DarshanTalks Podcast (Darshan Kulkarni)

 Istvan Fekete and Darshan Kulkarni discuss the 7 types of clinical trial agreements (CTAs). CTAs Explored Include: 

1.  Industry-Sponsored Trials, 
2. Phase Four and Post-Market Studies, 
3. Registry Studies, 
4. Federally Funded Studies, 
5. Drug and Device Studies, 
6. Consortium Studies, 
7. Investigator-Initiated Studies: 

We discuss the potential risks of seeding trials, and the need for both sponsors and sites to be vigilant about potential fraud and compliance issues.

Discussions include practical advice for both sponsors and sites, encouraging proactive feasibility assessments and streamlined concurrent negotiations.

The conversation underscores the multifaceted nature of clinical trial agreements, underscoring their pivotal role in advancing medical research while ensuring ethical practices and efficient collaborations. Join our discussion between Darshan Kulkarni and Istvan Fekete.

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#clinicaltrialagreements #researchcontracts #ResearchAgreements #compliancematters #medicalbreakthroughs #trialagreementtips #advancingmedicine #regulatoryguidelines #clinicaltrialethics #darshantalks #dt #kulkarnilawfirm #klf

Website: https://www.darshantalks.com/
Law Firm: https://kulkarnilawfirm.com/
Twitter: https://twitter.com/darshantalks

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 Isaac Rodriguez-Chavez discusses the role and the significance of the Decentralized Clinical Trials guidance. 
We discuss the following: 

• What are decentralized clinical trials? - 2:05- 4:25 
• What factors led to the rise of decentralized trials? – 4:26- 10:58 
• What is the role of decentralized clinical trials?- 10:59- 14:36 
• What is the process of FDA to develop a guidance?- 14:42- 17:48 

#innovativeapproaches #healthcarerevolution #industryinnovation #hybridapproaches #remotetrials #diversityintrials #patientcentrictrials #inclusiveresearch #clinicaltrials #clinicalresearch #patientempowerment #kulkarnilawfirm #klf #darshantalks #dt #recentrecap 

Sign up for our newsletter- https://darshantalks.com/ Website: http://www.darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ ---- 

Disclaimers: This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship 

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 In this episode, the focus is on planning #FDA meetings and the significance of pre-IND meetings. We discuss how pre-IND meetings are crucial for identifying and addressing any roadblocks or gaps in the preclinical program before the actual filing. By doing so, potential delays or complications during the clinical trial phase can be mitigated. The discussion also includes insights into optimizing dosing strategies in oncology phase two studies, prioritizing patient experience, and finding tolerable doses that allow for extended drug administration. The conversation touches on cultural differences in FDA approval approaches across regions and the collaborative nature of successful FDA meetings. Overall, the episode emphasizes the importance of preparation, data-driven justifications, and effective collaboration to advance drug development and ensure safe treatments for patients. Points discussed: FDA meetings and Pre-IND significance: 1:30- 3:48 Optimizing oncology dosing strategy: 3:49- 8:32 Navigating maximum tolerated dose across cultures: 8:33- 13: 56 Key Indicators to address: 13:57- 15:38 Collaborative FDA meetings: 15:39- 21:59 FDA meeting composition: 22:00- 25:16 Learning from virtual FDA meetings: 25:17- 27:42 Strategic planning for FDA meetings: 27:43- 28:42 #FDAMeetings #FDA #FDAInsights #DrugDevelopment #PatientCentric #FDAapproval #FDAteam patientexperiences #medicalinnovation #patientsafety #clinicaltrials #clinicalresearch #darshantalks #kulkarnilawfirm #dt #klf #recentrecap 

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 Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA examines various aspects like manufacturing, clinical research, pharmacovigilance, advertising, and distribution. FTC now addresses advertising and antitrust concerns. DOJ concentrates on corporate compliance. Is your organization well-prepared for these assessments? Get in touch with us for more information. 

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 The FDA's Center for Tobacco Products (CTP) was created in 2009 to regulate tobacco products. Micah Berman worked at CTP from 2011-2012. He discusses the CTP's evolution in the past decade and shares insights from his recent article published in the New England Journal of Medicine. We discussed the following: 

• When was Micah a part of CTP? - 0:58 - 1:27 
• What was the vision behind CTP's creation? - 1:35 - 4:48 
• What caused CTP to be created? / The background of how CTP was established – 5:07 – 12: 33 
• What was the reasoning behind the tobacco industry's move to be regulated by the FDA? – 12:35 – 17:16 
• What challenges did the FDA and CTP encounter when they first started regulating cigarettes, and how does the situation compare in 2023? – 17:17 – 25:19 
• Can the FDA shut down the entire tobacco industry? – 25:20 – 27: 30 
• How can the FDA, with its authority over tobacco product regulation, improve public health? – 27:31– 29:33 
• Micah talks about his article: 29:33 – 34:50 
• What should the FDA focus on while regulating tobacco products/cigarettes? – 34:57 – 40:08 

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 Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clinical trials. Specifically, Tatsene failed to test on the appropriate number of subjects, thus compromising the integrity and reliability of the trial data. How to Avoid this Fate: To sidestep such consequences, individuals and organizations must strictly adhere to FDA guidelines, which include rigorous clinical trial protocols like proper sample sizes for testing. Failing to do so could result in severe penalties, including debarment. Impact: This action sets a precedent that has significant implications for clinical researchers and Contract Research Organizations (CROs). Not only does it tarnish reputations but it also raises questions about data integrity, potentially delaying drug approvals and harming patients in the long run. 

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 AI expert Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI's potential impact across industries. Dave underscores that while LLMs can generate text, they lack true understanding. The conversation explores the challenges of scraping data for accuracy and ponders the future of AI, emphasizing the value of content creators and the necessity for expert verification in an AI-augmented world. We discussed the following: 

1.  Are the tools we are using AI or LLMs? 
2. Can these tools replace people? 
3. Can you provide two descriptive comparisons that are relevant to the current state of generative AI? 
4. What does generative AI represent right now? 
5. Is there value to having different large language models? 
6.  Why is it difficult to train these models? 
7. Who owns the results provided by these models? 

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 We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading promotion, as many unapproved applications lack scientific support. It's worth noting that the FBI oversees biohacking, despite its primary purpose not being generalized research. 

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 We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading promotion, as many unapproved applications lack scientific support. It's worth noting that the FBI oversees biohacking, despite its primary purpose not being generalized research. 

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 In this episode, we’ll discuss how to speed up your marketing approval process with these must know concept review tips. We will talk to Heather McFalls, Director of AD Promo at Organon. In this interview we will address the following questions: 
1.    How often do people do concept reviews? 
2.    Is it useful to have an attorney at the concept review stage? 
3.    Is the role of PRC advisory or quality-focused?
4.    Who owns the PRC process? 
5.     Should the PRC process be sequential or parallel? 
6.     Has AI been disruptive in the concept review process? 

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FDA is suggesting the use of one-pagers to provide essential drug information to patients. Past attempts faced challenges, such as one-size-fits-all content and patient trust issues. 
 
Darshan emphasizes that while the FDA's proposal is a step in the right direction, it must ensure that these one-pagers are comprehensive, accurate, and transparent. Patients often rely on healthcare providers and trusted sources like WebMD for drug information. This short explores the potential benefits and concerns surrounding this FDA initiative, stressing the need for precise and reliable drug information.

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The FDA has taken action by sending warning letters to eight companies that have been marketing unapproved eye products, potentially violating federal laws and risking consumer health. 

These companies include Boiron Inc, CVS Health, Dr. Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan USA or Similasan AG, TRP Company Inc., and Walgreens Boots Alliance Inc. 

These companies are now under increased scrutiny and may face legal consequences if they fail to comply with FDA regulations. They must either seek FDA approval for their products or remove them from the market to avoid further repercussions. 

Additionally, they need to establish appropriate marketing compliance programs to ensure accurate product labeling. 

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In this episode, guest Dave Bulger delves into the intricate role of AI, questioning whether it functions as a creator, a copycat, or perhaps both. Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI's potential impact across industries. Dave underscores that while LLMs can generate text, they lack true understanding. The conversation explores the challenges of scraping data for accuracy and ponders the future of AI, emphasizing the value of content creators and the necessity for expert verification in an AI-augmented world.

We discussed the following:

Introduction to the discussion- 1:09- 2:21

Are the tools we are using AI or LLMs?  2:23- 6:14

Can these tools replace people? 6:15- 9:45

Can you provide two descriptive comparisons that are relevant to the current state of generative AI? 9:46- 11:46

What is the current state of generative AI? 11:47- 13:05

Is there value to having different large language models?  14:26- 18:02

Why is it difficult to train these models on language using Reddit and other websites?  18:03- 19:51

What are your thoughts on content is king when we know that it's unsustainable? 19:52- 21:23

Who owns the results provided by these models? 21:41- 24:32

Should government agencies regulate AI? 24:33- 25:41

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On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data.
 
We highlight the significance of pharmacists recognizing red flags indicating potential fraud, including patients unknowingly or involuntarily enrolled in clinical trials.
 
Beyond the broader impact on public trust, pharmacists could face specific repercussions, such as disciplinary actions from the State Board of Pharmacy. Moreover, clinic owners could be barred from participating in research activities.
 
Implementing robust internal controls and collaborating with law enforcement to identify and report suspected fraud are essential steps for pharmacists and clinic owners to safeguard themselves from legal ramifications.

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The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process.
 
Key steps include:
1) Develop a risk-based framework- 0:39- 1:03
2) Get pre-market clearance or approval- 1:04- 1:37
3) Quality control and quality assurance- 1:38- 2:04
4) Adhering to FDA guidelines for labeling and marketing- 2:05- 2:21
5) Ensuring data security and patient privacy- 2:22- 2:43
6) Conducting post-market surveillance- 2:44- 3:03
7) Staying proactive in meeting new compliance requirements- 3:04- 3:20
 
For expert guidance on FDA approval and regulatory clearance, contact Darshan Kulkarni at 302-252-6959.
 

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We discuss the 7 things to do before closing your pharmacy:

1. Return your DEA registration,
2. Notify the Board of Pharmacy,
3. Dispose of controlled substances appropriately,
4. Inventory your pharmacy and create a clear inventory list,
5. Keep all documentation, especially for controlled substances, for at least 2 years,
6. Know where your records are stored, as the DEA may request them later and
7. Contact the Board to let them know that you will be transferring documentation and any drugs and/or devices.

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Virginia Tech recently received a $50 million gift from the Red Gates Foundation for Health Sciences research expansion. In light of recent news about research fraud prosecuted by the Department of Justice, it is crucial for the Fralin Biomedical Research Institute to implement robust research integrity policies.
Here are five key steps that the institute can take to address research fraud:
1.  develop and implement a clear research integrity policy,
2.  establish written procedures,
3.  provide comprehensive training on research integrity,
4.  form a research integrity committee, and
5.  encourage the reporting of suspected misconduct.

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Jessica Thompson discusses how project management can be a game-changer in clinical research.  We talk about how poor project management can lead to delays, cost overruns, and regulatory violations, and that lawyers can play a role in ensuring that clinical research projects are managed effectively. Thompson emphasized the need for early planning and communication between all stakeholders involved in a clinical research project.

Points discussed:

Do clinical research project management tools differ from those used in other industries?-  1:58- 4:25

What does the term 'critical path' mean?- 4:25- 6:34

How to companies respond to the concept of critical path?- 6:53- 8:46

How is Association of Clinical Research Professionals (ACRP) connected to Association of Clinical Research Project Managers (ACRPM)?- 9:54- 12:01

How should sponsors involve project managers in their projects?- 12:04- 18:47

Is a project manager different from a manager?- 19:07- 21:00

How do Kaizen and Lean Six Sigma fir into clinical research project management?- 21:02- 22:47

What is the significance of the Iron Triangle in clinical research project management?- 22:49- 28:08

What is the advantage of being a part of ACRPM?- 28:34- 30:48
 
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Planning to incorporate artificial intelligence into your business in 2024? Stay informed about the Federal Trade Commission's (FTC) expectations. In his discussion, Darshan Kulkarni highlights the FTC's recommendations for AI:
FTC expects that AI will foster fair, open and competitive markets,
FTC intends to use its tools to challenge unfair and deceptive practices involving claims based on AI including the use of AI to discriminate the and 
FTC intends to promulgate market-wide rules to address harms from AI this includes fake reviews impersonators and other issues.

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The case study on academic research center misconduct highlights the urgency to address and prevent such issues in the field. Instances of research misconduct, as exemplified by the Miami case, have drawn the attention of regulatory agencies like the Department of Justice, emphasizing the need for stringent oversight and ethical conduct. Examining the fictional case of Padre Pio Hospital in Philadelphia reveals the complexities and challenges involved in managing research misconduct, requiring strict adherence to FDA and IRB guidelines, staff training, and internal auditing. 
To effectively address the situation, a comprehensive compliance program, self-disclosure, and corrective actions as per the FDA, OIG, and DOJ guidelines must be implemented, underscoring the importance of ethical conduct, timely reporting, and ongoing staff training in research centers.

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Recently, Celia Sandhya Daniels was announced to be one of the top 20 LGBTQ leaders in Bio Pharma by Endpoints News.

In this episode, We're venturing into the captivating world of Diversity, Equity, and Inclusion (DEI) in the realm of pharmaceuticals and healthcare. Get ready for a journey that will unravel the mysteries and intricacies of DEI!

We’re joined by Celia Sunday Daniels, a seasoned professional with 25 years of experience in the pharmaceutical and healthcare industry.

We discuss:

Why is DEI crucial, especially in a world where companies could face scrutiny for advocating DEI? (3:07- 9:13)
How can we reconcile the goals of DEI with privacy concerns? (10:20- 18:32)
Does the FDA prioritize certain intersections more than others in its risk-based approach to DEI? (18:44- 24:33) 

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Darshan Kulkarni talks about how the generic drug industry is facing several challenges that are impacting profitability, including:

1. Pressure from insurers to lower prices,
2. Rising costs of manufacturing and distribution,
3. Inflation,
4. Supply chain disruptions and
5. Increased competition from other generic companies

Pharmacies are fighting back against these challenges by:

1. Bypassing wholesalers and negotiating directly with manufacturers,
2. Offering discounts and coupons to patients and
3. Partnering with other organizations to negotiate lower prices

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In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns raised by regulatory agencies such as the FDA, DOJ, FTC, and OIG. The discussion revolves around the risk-based review of outward-facing information shared by medical device companies. The podcast delves into seven hierarchical layers that dictate how organizations should approach compliance. These layers include:

1. The Constitution (First Amendment): Highlighting the clash between First Amendment rights like free speech and FDA regulations. Emphasizes the importance of truthful and non-misleading information.

2. Laws Made by Congress: Discussing how laws such as the Food, Drugs, and Cosmetics Act set the rules but can be ambiguous, potentially leading to regulatory challenges.

3. Regulatory Agency Interpretation: Exploring how FDA, FTC, and OIG interpretations through regulations, guidances, and enforcement actions add another layer of compliance focus for Pharma companies.

4. CIA Settlements: Examining Integrity Agreements or CIA settlements as legal precedents that set industry wide regulatory expectations for Pharma companies.

5. Industry Codes: Discussing voluntary codes like Pharma or AdvaMed codes, which, while not legally binding, may influence industry standards.

6. Internal Policies: Highlighting the importance of company-set policies for day-to-day operations, which are more conservative than the law but serve as prudent forms of engagement.

7. Personal Risk Tolerance: Acknowledging that individual risk tolerance varies, and while policies guide the process, they won't eliminate personal risk tolerance.

The podcast emphasizes the need for companies to navigate these layers carefully and stay informed and compliant. It concludes with an invitation to seek assistance in creating digital health engagement programs by contacting the speaker via email at darshan@kulkarnilawfirm.com

Website: http://www.darshantalks.com
Law Firm: http://www.kulkarnilawfirm.com
Twitter: https://twitter.com/darshantalks
LinkedIn: https://www.linkedin.com/in/darshanku...

----
Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depen

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Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally not. Key considerations include the complexities of handling publication rights, the impact of tax-exempt municipal bonds on project restrictions, ensuring equal patient treatment, the reality of universities generating revenue from intellectual property, the distinct goals of principal investigators versus institutions, and the necessity of a comprehensive congruence review among documents related to clinical trial agreements.
 
Points discussed:

1. What are the 6 big areas that large academic medical institutions tend to think about that sponsors or smaller hospitals/private institutions may not be thinking about in the context of clinical trial negotiations? - 2:29- 4:55
2. Are tax-exempt municipal bonds a factor in clinical trial negotiations? 4:58- 12:03
3. What is the impact of the Bayh-Dole Act on publication rights? 12: 04- 13:40
4. Why do we not discuss confidentiality as much as we talk about publication rights?- 13:41- 21:26
5.  Should sponsors have the right to be present during an FDA audit in a large medical center?- 21:27- 24:19
6. Should sponsors have a right to review and change a proposed audit in the case of a larger academic medical center? Check out our latest podcast episode to find out. 24:20- 26:20
7. 6 different types of clinical trial transparency. - 26:21- 29:30 

Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship.

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This week, a data breach was disclosed by 23andMe, affecting 6.9 million users and compromising their genetic data information.

The incident raises significant concerns about data privacy and security. It's important to note that while some perceive this as a violation of HIPAA, it typically doesn't apply to direct-to-consumer genetic testing services like 23andMe, as they don't involve covered entities such as physicians. This leaves a gap in privacy protection, and alternative legal frameworks, such as those enforced by the Federal Trade Commission, may come into play. However, actions against direct-to-consumer genetic testing companies by the FTC have been rare. The breach highlights the need for increased awareness and potentially new laws and regulations to safeguard sensitive genetic data in the rapidly evolving digital landscape.

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In a significant update on September 19th, Samuel Levine, Director of the #FTC's Bureau of Consumer Protection, outlined the agency's key priorities at the National Advertising Division's annual conference. Levine emphasized a three-pillar enforcement agenda. 
The first pillar targets practices causing substantial consumer harm, 
While the second aims not only to cease violative conduct but also alter incentives to deter future misconduct and 
The third pillar introduces tools beyond case-by-case enforcement, emphasizing corrective and preventative actions (CAPA). 
Levine's increased focus on substantive concerns and his expressed concern about "dark patterns" highlight a proactive stance in FTC enforcement. 

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Darshan Kulkarni discusses the FDA's IT strategy for 2024 to 2027. The FDA aims to create a unified FDA ecosystem, promote cross-functional collaboration, and foster a more integrated organizational culture. Key goals include 
strengthening IT infrastructure, 
modernizing enterprise services, and 
optimizing the IT services portfolio for stable, resilient, and adaptive solutions aligned with mission needs. 
The FDA emphasizes the importance of sharing data to drive efficiency, excellence, and public health innovation. Additionally, the strategy involves adopting artificial intelligence and staying proactive in identifying opportunities and risks related to emerging technologies.

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Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations.

The draft guidance emphasizes the significance of technological characteristics. If the new device shares the same technological characteristics as the predicate device, the 510(k) summary should include a comprehensive summary of these features.

Design-related recalls take center stage in the FDA's recommendations. The agency discourages choosing a predicate device that has been subject to a design-related recall. If a submitter opts for such a device, they must explicitly address how they've mitigated the safety concerns that led to the recall.

Transparency and documentation constitute the third crucial consideration. The FDA stresses the need for a detailed 510(k) summary that provides a comprehensive understanding of the basis for determining substantial equivalence.

The guidance encourages the inclusion of a narrative explanation in the 510(k) summary. This narrative should elucidate the process behind selecting the predicate device, offering transparency and insight into the decision-making process.

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In this podcast episode, we'll uncover five strategies to expedite the digital promotion review process. Starting with
1. Policy creation and training emphasizes aligning policies across platforms, incorporating key stakeholders' expectations, and ensuring consistency with relevant agreements and guidelines. 
2. Pre-review meetings with marketing teams help establish a shared perspective, streamlining the process.
3. AI-based tools offer preliminary data analysis, although current applications are somewhat basic. 
4. Modular approvals involve reviewing individual components before the final review, aiming to accelerate the overall process. 
5. Lastly, applying quality learnings from past programs aids in avoiding mistakes and optimizing the promotional review process. 

Tune in for more insights and tips!  

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he recently issued FDA guidance mandates manufacturers, packers, and distributors to adhere to new standards, emphasizing mandatory product and facility registrations, creation of safety substantiation information, and implementation of adverse event reporting. Daron breaks down key definitions, clarifies information submission processes, and discusses public accessibility. 

Tune in to stay informed about the crucial expectations, including adverse event reporting, recordkeeping, and safety substantiation, to ensure compliance with the evolving regulatory landscape.

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In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed:

1. Privacy Compliance:
   - Consider where audience data will be stored and ensure compliance with privacy laws (TCPA, CCPA, GDPR, etc.).
   - Prioritize secure handling of sensitive information and always obtain audience consent.

2. Transparency and Disclosure:
   - Adhere to FTC requirements for transparency and disclosure.
   - Communicate upfront about sponsorships, product claims, and any financial relationships impacting the content.

3. Controlled Audience Targeting:
   - Tailor the digital presentation to specific individuals or groups.
   - Adjust tone, scientific detail, and compliance messages based on the target audience (e.g., clinicians, P&T committees).

4. Distinguishing Marketing from Education:
   - Clearly differentiate between marketing and educational content.
   - Ensure that educational materials genuinely inform without serving solely as a sales pitch to benefit from legal protections.

5. Product or Health Claim Evaluation:
   - Scrutinize the presentation topic to determine if it constitutes a product claim or a disease awareness advertisement.
   - Adhere to FDA requirements for product claims, ensuring substantial evidence, while disease awareness ads follow a lower scientific evidence standard.

For assistance with digital engagement or marketing programs, contact Darshan Kulkarni at darshan@kulkarnilawfirm.com

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The National Advertising Division (NAD) recently examined a TV ad by Bravecto, comparing its flea and tick prevention product with NexGard's. The ad suggested Bravecto's greater effectiveness, disputed by NexGard. NAD sided with NexGard, emphasizing the need for clear and conspicuous disclosures in comparative advertising.

 In a separate case, Google's ads for YouTube TV claimed a $600 cost savings over cable, leading to a dispute with a cable provider. NAD supported the cable provider, stressing the importance of clear definitions for comparable services to prevent consumer misinterpretation. 

These cases underscore the FTC's focus on addressing ambiguous and misleading comparative claims, particularly in drug product advertising—a realm already subject to FDA caution.

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In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of computer science, statistics, and engineering, employs algorithms to perform tasks like learning, decision-making, and prediction. Within the context of drug development, we unravel three significant applications of AI. First, it aids in scanning medical literature for pertinent findings; second, it predicts individual responses to treatments and assesses side effect risks; and third, it enables the creation of digital twins for intervention modeling.

Join us as we navigate the potential of conversational agents and chatbots equipped with AI, serving as invaluable tools in clinical trial inquiries and adverse event reporting. Yet, the integration of AI comes with its own set of risks. As regulatory bodies like the FDA shift toward a risk-based analysis approach, it is crucial for stakeholders—whether practitioners, sites, sponsors, or research organizations—to remain vigilant and comprehend the evolving regulatory landscape. In this episode, we shed light on the impact and risks associated with AI in drug development, offering insights into navigating this transformative era.

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In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care Option (CRACO). While the concept seems promising, particularly for patients with conditions like rare diseases or cancer, it introduces a host of concerns. The alignment of Institutional Review Board (IRB) goals with the essence of a clinical study becomes pivotal. If the trial's outcome is already known, it may be labeled a seeding trial, raising ethical and FDA-related red flags. Conversely, administering a drug with uncertain effectiveness to a hopeful patient brings its own set of ethical and legal challenges. 
This evolving landscape demands careful consideration and resolution of ethical and legal issues associated with integrating clinical research and care. 

Stay tuned as discussions on this innovative approach continue to unfold.

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We explore the crucial aspects outlined by the FTC regarding comparative claims in drug and device advertising. 
the paramount importance of transparency in promotional efforts,
the pitfalls associated with broad generalizations, and 
the need for readiness in the face of scrutiny from both the FDA and the FTC.

Providing a valuable intersection of pharmacy, law, and marketing, our short offers a comprehensive guide for navigating the complex landscape of comparative claims in the healthcare industry. 

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We discuss five key legal and regulatory considerations for a digital sales force:
Starting with updates to the Physician Payment Sunshine Act, emphasizing the need for training, robust internal controls, and monitoring.
 It also touches on guidance for interactions with healthcare professionals, emphasizing transparency and ethical practices.
 The SIUU guidance is discussed, emphasizing accurate and fair presentation of scientific information.
The updated CMS guidance recommends comprehensive compliance programs, promoting a culture of compliance and
Lastly, the DOJ pilot program for clawbacks in employment agreements is outlined, urging employers to review agreements, establish clear policies, and conduct due diligence.
Addressing these considerations ensures digital sales forces contribute to an ethical and responsible healthcare industry, requiring companies to stay updated and provide ongoing training.

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Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state or area, its reach (national, international, or local), and the associated costs. He warns against the trend of traditional marketing companies entering the clinical trial recruitment space, advising careful assessment of their experience and disease state knowledge. He also suggests that while this trend is emerging, its ultimate impact remains uncertain. Additionally, he concludes by encouraging those in need of assistance with training, policy development, or gap analyses to contact Darshan Kulkarni at darshan@kulkarnilawfirm.com

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Accelerate your digital speaker program review with these 5 game-changing strategies:
 Policy Creation & Training
 Pre-reviews
 AI-based Reviews
  Modular Reviews
Applying Quality Learnings Across the Program

Dive deeper into each strategy on our podcast! 

Watch the full podcast- https://www.youtube.com/watch?v=Ud8jn4c3cCM 

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Insider Exposes crucial missing step in Clinical Trial Agreements activation - Congruency Review Details Revealed!

In the clinical trial agreement activation pathway, the journey involves several critical steps. It begins with the signing of the Confidentiality Disclosure Agreement (CDA), followed by the study team's review of the protocol and feasibility goals. Once the study gets the green light, the congruency review phase becomes crucial. This phase kicks off with a Medicare coverage analysis to determine what falls under research billing and sponsor billing versus insurance billing.

The Medicare coverage analysis further involves creating a detailed calendar and schedule of events in the clinical trial management system. Budget negotiations come into play, and once finalized, the financial console aligns with the clinical trial management system calendar. Simultaneously, contract and informed consent negotiations occur, often involving multiple groups within the institution and various vendors.

Despite the complexity, there's a notable gap in the industry – the lack of comprehensive congruency review. This gap is observed both on the site side and the pharmaceutical side. Many times, discrepancies arise when regulatory discussions conflict with legal interpretations, and there's no final congruency review to ensure alignment between the Medicare coverage analysis, calendar, budget, contract, and informed consent form. Bridging this gap becomes pivotal to ensure a seamless and error-free process.

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FDA Issues Crucial Guidance on Prescription Drug Software! 

Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key considerations:
1. software functions, 
2. end-user output, and 
3. regulatory guidelines. 

Notably, the FDA emphasizes distinguishing between functions relying on direct device data transfer and those that don't. The document also outlines the significance of characterizing software output, such as symptom data and alerts. Lastly, regulatory guidelines stress that functions not directly transferring device information should be omitted from product information unless essential for safe use, with details to be determined on a case-by-case basis. Tune in for expert insights into this pivotal FDA update!

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In this podcast, we discuss the legal and regulatory factors for securing approval for your digital speaker program. Key points include 
prioritizing audience privacy, 
adhering to FTC disclosure regulations, 
explicit audience definition, 
distinguishing between educational and promotional content, and 
navigating health versus product claims. 

Link to the detailed podcast:  https://www.youtube.com/watch?v=MH6UEY_I-kI

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Darshan discussed crucial updates to the Department of Justice's (DOJ) corporate enforcement policies, particularly impacting FDA-regulated industries like pharmaceuticals and medical devices. The DOJ's focus on mergers and acquisitions (M&A) emphasizes the importance of compliance professionals throughout the entire process.

Key Highlights:
1. Corporate Enforcement Policies Update: The DOJ has introduced significant changes to its corporate enforcement policies, impacting companies engaged in M&A transactions. Compliance professionals are now essential stakeholders at the due diligence table.

2. Antitrust Division's Impact on Pharma: Recent cases involving pharmaceutical companies Teva and Glenmark showcased the DOJ's shift in approach. Divestiture of a core product was required, marking the first instance of such a demand in a corporate criminal resolution.

3. Compliance Program and Compensation: The new pilot program mandates companies to incorporate compliance-promoting criteria into their compensation systems. The DOJ urges companies to address this now, emphasizing the need for proactive compliance policies.

4. Voluntary Self-Disclosure Policy: The DOJ announced a voluntary self-disclosure policy, creating a safe harbor for companies that promptly report wrongdoing. The policy encourages self-reporting, offering a presumption of declination for qualifying companies.

5. Qualification for Safe Harbor: Companies must disclose misconduct within six months of acquisition, with one year to fully remediate. These deadlines may be extended based on case specifics. The Safe Harbor applies only to criminal conduct in bona fide M&A transactions.

6. DOJ Principles: The DOJ aims to hold wrongdoers accountable, incentivize compliance, and deter repeat offenses. The new policy offers a presumption of declination for companies self-disclosing, cooperating, and remediating.

7. Impact on Pharma and Device Companies: FDA-regulated industries, particularly pharmaceutical and device manufacturers, may benefit from the clear safe harbor. Voluntary self-disclosure, under the new policy, could become more common in the life sciences sector.

8. Considerations and Conclusion: Companies must carefully evaluate when self-disclosure is appropriate, with minor regulatory violations potentially better handled directly with the FDA. Compliance teams play a vital role, and ongoing developments at the intersection of compliance and FDA regulation will be closely monitored.

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In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law Firm, the episode highlights key points:

1. Scientific discussions: Courts are generally cautious about FDA scrutiny in scientific discussions, such as those in academic conferences or scholarly articles, falling within FDA safe harbors.

2. Consistent with label guidance from the FDA: Sharing information aligning with the appropriate use of a drug or device, even if not explicitly mentioned, is legally acceptable.

3. FDAMA 114:  The guidance emphasizes sharing health economic information, including off-label data, with specific entities.

4. SIUU guidance: It introduces a nuanced framework for discussing information implying off-label use, necessitating companies' awareness of its implications.

5. Education and non-company representatives: Engaging in discussions independent of pharmaceutical companies, provide crucial avenues for off-label information sharing, avoiding FDA scrutiny.

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We delve into the growing allure of clinical research sites and organizations for private equity firms. Backed by BPOC, these investments signify more than just single business deals; they are a testament to the increasing interest in fueling healthcare innovation and services.

As this trend gains momentum, thorough due diligence becomes crucial in navigating the complexities of these acquisitions. The Kulkarni Law Firm, specializing in Life Sciences law, plays a pivotal role in providing comprehensive support for regulatory compliance, contract reviews, and risk assessments. Daron emphasizes that these investments go beyond financial gains, contributing to the redefinition of the healthcare investment landscape.

The Kulkarni Law Firm keeps a watchful eye on the latest updates from the Department of Justice (DOJ), Office of Inspector General (OIG), and the Food and Drug Administration (FDA), ensuring that clients are well-informed and compliant. 

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In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves accurately analyzing Medicare coverage, determining designations based on National and Local Coverage Determinations. This forms the foundation for what is billed to the study sponsor and insurance. Any discrepancies at this stage can lead to downstream errors.

Following the coverage analysis, it becomes imperative to align the calendar with the protocol's schedule of events and the designated elements from the coverage analysis. Once the calendar is established, the focus shifts to the budget negotiation phase. Multiple touchpoints during budget negotiations necessitate periodic checks to confirm alignment with the calendar and coverage analysis designations.

On the contractual side, congruency revolves around matching the contract and budget provisions. This involves verifying that payment terms and the final budget in the contract align with the negotiated terms. Another critical aspect is ensuring congruency between the informed consent and the contract, specifically focusing on subject injury language. Standardized language for subject injury in both the informed consent and contract streamlines the congruency process. Deviations from these standards trigger communication between those handling the informed consent and contract to ensure alignment. This meticulous congruency review safeguards against discrepancies and ensures a seamless process in clinical research.

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In December 2023, two US senators raised concerns, urging the government to scrutinize the FDA's oversight of medical device recalls, notably amidst the ongoing Phillips Respironics recall.

Join us today as we delve into the world of medical device recalls. Facing a recall is every manufacturer's nightmare, but handling it right is paramount. It safeguards patients, preserves reputations, and sidesteps legal nightmares.

Educate Yourself: The first step? Knowledge is power. Familiarize yourself with FDA guidance – understanding what you can, should, and must do. Develop policies consistent with this guidance to fortify your approach.

Transparency Is Key: Building trust is pivotal. Be upfront with the FDA when necessary. Clear, concise communication lays the foundation for swift and effective action.

Meticulous Planning: Plan with precision. Consider logistics and support. Identify affected devices, create a comprehensive notification strategy, and establish clear instructions for replacement or return. A well-thought-out plan is your best defense.

Legal Support Matters: Recalls happen, but with the right legal partner, you can minimize the impact. The Kulkarni Law Firm is here to help you navigate recalls with reassurance, ensuring the protection of your patients and your business.

Trust the Kulkarni Law Firm to guide you through the maze of medical device recalls, ensuring minimal scars and maximum protection. The path to a well-managed recall starts here.

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We discuss biotech fraud and the pivotal role of a comprehensive legal strategy, especially one that integrates FDA regulatory lawyers. A biotech CEO's admission to securities fraud, misleading investors about a crucial test, underscores the need for stringent legal oversight.

At the Kulkarni Law Firm:

We’re on the lookout for major red flags, 
We ensure press releases not only comply with SEC regulations but also meet FDA requirements. 
Evaluating the scientific accuracy of information, 
Analyzing clinical data, 
Understanding regulatory pathways, and 
Ensuring public disclosures are truthful.

An effective legal strategy, integrated with FDA regulatory lawyers, collaborates with communication teams, works closely with the R&D department to grasp the science behind claims, and liaises with compliance teams to cover all regulatory bases. By integrating FDA regulatory lawyers into the communication process, companies can prevent missteps, rigorously vetting public statements for accuracy, legality, and scientific validity. This proactive approach significantly reduces the risk of misleading investors and the public, addressing concerns related to fraud and compliance.

For expert guidance on navigating the complex intersection of securities, FDA regulations, and legal compliance, look no further. Call us at 302-252-6959. 

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In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in light of the SIUU guidance and the CFL guidance. The First Circuit ruled against Facteau, emphasizing the distinction from the Caronia case. Unlike Coronia, where the focus was on broader free speech and off-label promotion issues, the US v. Facteau case centered on the roles and actions of individuals involved. Notably, Facteau's direct executive involvement in promoting off-label uses, coupled with evidence of intent to circumvent FDA regulations, set this case apart. This ruling highlights the nuanced considerations surrounding off-label marketing and underscores the importance of individual actions and intent in legal outcomes.

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In a recent announcement, Elon Musk's company Neuralink revealed the successful implantation of a brain device in a human, pushing the boundaries of neurotechnology.
 In our latest short, we discuss key considerations for those venturing into such groundbreaking work. 
We emphasize the importance of having a clear investigational plan that outlines study design, methodologies, endpoints, and analysis strategies. 
Additionally, we also highlight the significance of obtaining adequate informed consent to address potential health risks 
The need for meticulous record-keeping for regulatory compliance, including maintaining detailed delegation logs and up-to-date resumes.
These measures are crucial for navigating the complexities of both technological advancements and regulatory policies in this innovative field.

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eBay found itself as an unexpected marketplace for pill-making equipment, resulting in the company paying a hefty $59 million for facilitating the sale of such equipment. In our video, Darshan delves into this crackdown, shedding light on the hidden underbelly of online retail. The incident highlights the ease with which tools for potentially illegal drug manufacturing can evade e-commerce oversight. He emphasizes the importance of consulting with consumer safety and regulatory lawyers before engaging in the sale of materials that could be easily diverted in the digital age. The podcast serves as a cautionary tale, urging awareness and proactive measures in the ever-evolving landscape of online commerce.

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The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implications. 
We provide a comprehensive overview of seven strategic approaches for LDT developers to challenge the FDA's regulatory proposal. 
Firstly, leveraging the public comment period,
Participating in Part 15 hearings provide direct avenues to voice concerns and influence final regulations,
Additionally, joining industry associations allows for collective lobbying efforts on behalf of developers,
Exploring legal challenges, though potentially premature without final action, remains an option,
Raising public awareness through media campaigns is suggested, emphasizing the benefits of LDTs and drawbacks of proposed regulations. 
Collaboration with healthcare providers to gather real-world evidence and testimonials strengthens the developers' case. 
Lastly, engaging in congressional lobbying harnesses legislative power to potentially alter or block the FDA's proposals. 
Despite the FDA's focus on patient safety, developers are presented with a multi-pronged approach to effectively challenge and shape the outcome of the regulatory process.

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Today, we analyze a fictional drug advertisement, identifying and highlighting the nine key unethical and non-compliant elements.
- Misleading Information: The claim "The End of High Blood Pressure" suggests that the drug can completely cure high blood pressure, which is likely exaggerated and misleading.
2- Absolute Efficacy Claims: Stating "Proven to work in 100% of patients" is an absolute claim that is unrealistic and unsubstantiated, making it misleading.
3- Ignoring Risks and Side Effects: The risks and side effects are not prominently displayed, which fails to provide a balanced view of the drug’s benefits and risks. Additionally, the color and font is difficult to read.
4- Small Print for Important Information: Essential information in tiny, unreadable font is a common tactic to downplay risks and is generally inappropriate.
5- Adverse Event Reporting- Should include a statement saying "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088."
6- Lack of Supporting Data: Claims made in the advertisement are not likely unsupported by scientific data, which is misleading and non-compliant.
7- Efficacy Claims: Claims like "The End of High Blood Pressure is unrealistic, as is "Proven to work in100% of patients without any side effects"
8- No Mention of Generic Name: Not including the generic name of the drug can be considered a violation of advertising standards.
9- Omission of Necessary Lifestyle Changes: Failing to mention that the drug should be used in conjunction with lifestyle changes and possibly other medications provides an incomplete picture of the treatment process.

Did we miss anything? Let us know in the comments.

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In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical companies and research sites share the responsibility for ensuring congruency between the budget, contract, informed consent form (ICF), and coverage analysis. Istvan mentions that a lack of congruency affects both parties and, therefore, both sides should actively participate in the vetting process. While pharmaceutical companies are responsible for ensuring budget and contract congruency, research sites should also conduct thorough reviews to align coverage analysis, budget, and contract. In Istvan’s view, it's not an either-or scenario; both sides play a crucial role in maintaining congruency throughout the clinical trial process.

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We explore the chemical similarities and key differences between brand-name and generic drugs. Learn about:
Equivalence in active ingredients, as approved by the FDA.
Exceptions: Narrow Therapeutic Index drugs and inactive ingredients.
When to consult a doctor before switching brands.
Listen to find out if you can save money without sacrificing quality!

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In an ideal world, every patient in clinical trials would feel truly represented. In this video, Darshan Kulkarni outlines three crucial takeaways for collecting diversity data in clinical trials, following guidelines from the FDA.
 The guidance emphasizes that one size does not fit all when it comes to race and ethnicity, encouraging detailed categories to embrace the global diversity of participants. 
Darshan advises starting by asking about identity, specifically Hispanic and Latino, before delving into race, respecting the complexity of ethnicity and allowing participants to self-identify. 
He emphasizes the importance of trusting participants to share their own stories, asserting that self-reported data on race and ethnicity is not only more accurate but also honors individual identity, contributing to a more nuanced and enriched dataset.

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McKinsey’s vision for Medical Affairs in 2030 envisions profound integration of digital tools, analytical innovation, evidence generation, and leadership transformation. However, this vision faces a critical challenge as recent lawsuit losses against the FDA have shifted the landscape. Previously, Medical Affairs held the exclusive right to share off-label information, but FDA losses prompted guidelines allowing sales reps, under supervision, to share such information.
This regulatory change provides a more cost-effective approach for companies, challenging the traditional role of Medical Affairs representatives. Artificial intelligence is also emerging to supplement or replace certain functions of Medical Affairs in a compliant manner. The evolving landscape necessitates Medical Affairs to swiftly redefine its role with a strategic vision to avoid becoming sales-centric, potentially jeopardizing its educational and patient-centric functions.
Without a clear vision, Medical Affairs risks devolving into sales roles, hindering its potential impact on patient outcomes. The legal and regulatory reality demands a careful alignment of Medical Affairs activities with compliance. 
For further insights and compliance discussions in Medical Affairs, contact at 302-252-6959. Stay tuned for more updates! 

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Bringing a drug to market is a costly and intricate process, averaging $2.3 billion. This expense encompasses multiple levels of testing, ranging from small animals to extensive human trials. The drug company, whether partnering with a university or a private investor, foots the bill for each phase of testing, ensuring safety and efficacy before reaching the market. The investment covers meticulous testing procedures, safeguarding against potential risks and ensuring the drug's viability on a large scale.

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Here are 5 clinical trial record retention problems.
1. Fabricating Data and Documentation,
2. Forging the Principal Investigator's signatures,
3. Data Manipulation,
4. Misappropriating Samples and 
5. Forging Subject Dairies

Join us as we delve into the complexities of record retention and data integrity in clinical trials. Learn why compliance is key for FDA approval and how we can help. Call us at 302-252-6959 for expert assistance with your clinical trial compliance program.

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In this video, Darshan distinguishes between dietary supplements and drugs. The 
primary difference lies in the claims they can make. Dietary supplements are treated as foods and can only make limited claims, such as improving health or well-being. In contrast, drugs undergo rigorous FDA approvals and trials to make claims of curing, treating, preventing, or mitigating diseases. While there may not be much difference chemically, the key distinction is in the level of proof required for their claims. Darshan highlights that drugs may have once been dietary supplements but must meet higher evidentiary standards. 

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We cover three steps for preventing food recalls:
Identify all potential hazards.
Focus on known and foreseeable risks.
Develop preventive controls for specific hazards.
Ensure every bite is safe! Need help? Call Darshan at 302.252.6959.

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Have you ever wondered why your prescription takes what feels like an eternity to fill at the pharmacy? Darshan will shed some light on the process. 

When you drop off your prescription, the pharmacist isn't just mindlessly grabbing bottles from shelves. They're meticulously reviewing your medication to ensure it's the right fit for your condition, checking for potential interactions with other drugs or even your diet, and making sure it's covered by your insurance.

This detailed process, while aided by computer systems, often requires a human touch and can take some time. And remember, you're not the only one waiting for their medication – there's a queue of patients with prescriptions to fill.

So next time you're twiddling your thumbs in the pharmacy waiting area, remember that your pharmacist is doing their best to ensure your health and safety.

 

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When acquiring a drug or device company, regulatory attorneys play a crucial role in ensuring compliance during the due diligence process. It's vital to recognize that registration with state and local authorities is often overlooked by these companies, who may mistakenly believe that FDA registration suffices. However, failure to register appropriately with state and local authorities could lead to sales restrictions within those jurisdictions. Each state has its own criteria for registration, which can vary widely. Depending on the circumstances, a company may need to register as a manufacturer, distributor, or wholesaler. 

Consulting a regulatory attorney is essential to ensure proper registration and avoid potential complications down the line.

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In this short, Darshan sheds light on the relationship between doctors and pharmaceutical companies. He explains how pharmaceutical companies often pay doctors to ensure they understand their drugs and promote their products. 
However, patients can now access information on what doctors are being paid by pharmaceutical companies through the CMS website, as mandated by the Sunshine Act Law. This transparency allows patients to make informed decisions about their healthcare.

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We discuss the five common reasons behind the failure of mergers, acquisitions and licensing deals  in the life sciences industry. 

Inadequate understanding of capability, where focusing solely on financials without comprehending the target company's regulatory and compliance processes leads to failure. 
The side project dilemma, illustrated by Philip Morris' venture into pharmaceuticals, emphasizing the importance of aligning with core business objectives. 
Clash of perspectives, exemplified by cultural and business differences between BioGene and Novartis, highlighting the necessity of alignment in strategic vision. 
Low margins on generic drugs, as seen in Teva's acquisition of Actavis, revealing the 
challenge of profitability in this sector.
Overpaying, stressing the significance of thorough due diligence to avoid paying more than a company's actual value. 

For assistance with M&A due diligence, contact us at 302-252-6959.

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1. Recent updates from the courts in class action lawsuits. 
2. Difference between equity and law. 
3. Demerging or diverging equity and law. 
4. Dictionaries used by courts to interpret contracts. 
5. Update on Johnson and Johnson baby powder case (Suing plaintiff’s witnesses for defamation and false advertising) 
6. Experts need to be cautious to avoid false advertising allegations against them. 
7. Update on Maybelline 24-hour make-up case. (24-hour sunscreen)  

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Darshan explains that drugs work by either enhancing or inhibiting processes that already occur in the body. Put simply, they amplify or reduce the body's natural functions. This fundamental principle underscores how drugs interact with our biology. 

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Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address 
concerns with a knowledgeable medical professional. For minors, parental involvement is required, and subjects have the right to withdraw consent at any time. It's not merely a form but an ongoing process that starts before the research begins and continues until the study concludes or the subject withdraws. 

Need assistance with your clinical trial compliance program? Email us at darshan@kulkarnilawfirm.com

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We discuss six critical errors in the informed consent process:

1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process.
2. Lack of Detailed Discussion: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects.
3. Inadequate Training: Coordinators lacked knowledge about the study and lacked a research background, leading to insufficient information provided to participants.
4. Unauthorized Handling of Paperwork: Unqualified individuals would sign required forms without proper understanding or expertise.
5. Lack of oversight: Subjects were allegedly denied meetings with sponsors, FDA, or IRB, citing privacy laws as a barrier.
6. Signature Verification Issues: Signatures were not compared with subjects' identification, posing challenges in ensuring the authenticity of informed consent.

For assistance with clinical trial compliance, contact Darshan at 302-252-6959

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We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. These consequences include

1. Hefty fines, revoked licenses, and even legal charges, potentially ruining your business. 
2. Additionally, non-compliance can result in reputational damage, eroding public trust and deterring potential partners. 
3. Moreover, loss of distribution rights could leave you unable to serve customers in entire states.

 To avoid this nightmare scenario, ensure registration with state boards of Pharmacy. For
 assistance, contact us at Darshan@kulkarnilawfirm.com

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We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.

We discuss the following:

1. What does off-label mean from a reimbursement standpoint? 
2. Lessons from the US v. Eli Lilly 2009 case 
3. How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau 
4. How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid? 
5. How are compounded drugs reimbursed? 
6. Could a company be held accountable for off-label use of a drug due to
7.  compounded products? 
8. Are weight loss drugs exempted from reimbursement? 

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We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer patients. While the situation is improving, shortages still exist for some drugs. Staying informed is crucial, and the FDA is actively tracking drug shortages to mitigate them. 
It's important to communicate with your doctor, who can provide the latest information and discuss alternative treatment options tailored to your needs. 

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Buying a Drug or Device Company? 6 Compliance Must-Knows
Thinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown:

The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it!
The DOJ demands strong compliance programs with thorough risk assessments, effective training, and clear reporting channels.
Companies can now claw back bonuses from employees who break compliance rules.
Accurate risk assessments, comprehensive training, and clear misconduct reporting are key for HHS compliance. 
Disclosing payments to doctors and hospitals is crucial too, with details readily available online.
Don't forget about mandatory clinical trial disclosures on ClinicalTrials.gov. Skipping this can lead to hefty fines and hinder future research.

Need Help Navigating M&A Due Diligence? We can help! 

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Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or presentation to fellow HCPs regarding a specific drug, device product, or disease state on behalf of the sponsoring company. Typically, the company compensates the speaker with an honorarium and may also provide remuneration, such as free meals, to attendees. Between 2017 and 2020, drug and device companies reportedly paid nearly $2 billion to HCPs for services related to speaker programs. It's important to note that some iterations of these events are referred to as drug dinners.

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In today’s short, Darshan discusses why drugs cost so much. It takes around 10 to 15 years and roughly $2.3 billion to bring a drug to market. That means a drug company spends between $420,000 and $630,000 daily during this process. Imagine going to a casino every day, betting that much money without knowing the outcome, for 10 to 15 years. What kind of return would you expect on that investment? That's why drugs are so expensive.

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Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and the law. 

In this podcast series, we'll dive deep into AI's role in promotional and non-promotional communications within the pharmaceutical and medical device industries. From regulatory compliance and ethical considerations to the latest FDA guidance, we'll cover it all. Whether you're a legal professional, an industry insider, or simply curious about the future of AI in healthcare, this series will provide the insights and expert analyses you need to stay ahead of the curve. Let's get started!

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In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not without its legal and ethical dilemmas. Take, for instance, the New York Times' lawsuit against OpenAI, highlighting the contentious issue of data ownership. As pharma companies increasingly rely on AI for content generation, they must navigate murky waters to ensure compliance with existing regulations and respect for intellectual property rights.

Controlling AI output presents another challenge. Unlike human creators, AI can produce content that may not align with intended guidelines or quality standards. For pharma, where precision and compliance are paramount, this unpredictability poses risks. It's crucial for companies to implement robust review processes, involving both legal and regulatory teams, to mitigate potential errors and ensure content accuracy.

Moreover, the issue of ownership looms large. Both legal and regulatory bodies have expressed concerns about the ownership of AI-generated content. The US Patent and Trademark Office requires human oversight to verify accuracy and compliance with existing rules. Similarly, the US Copyright Office has stringent criteria for copyright protection, requiring human authorship. This raises questions about how much human intervention is necessary before AI-generated content can be considered owned or copyrighted.

In conclusion, while AI offers immense potential for innovation in content creation, pharma companies must navigate a complex legal and ethical landscape. By staying informed, implementing robust review processes, and seeking legal guidance, companies can harness the power of AI while ensuring compliance and ethical use. For tailored advice on integrating AI into your content strategy, reach out to us at the Kulkarni Law Firm. 

Stay tuned for more insights on navigating the evolving landscape of AI in pharma.

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Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk. 

Here are 5 tips for pharmacy owners and managers to prepare for potential temporary closures:

1. Cross-Train Staff: Train front-end staff on basic pharmacy procedures (depending on state regulations) so they can assist with paperwork like taking in prescriptions and completing end-of-day tasks.
2. Stock Up on Prescriptions: Anticipate closures by keeping a surplus of routine 
3. prescriptions filled. This ensures patients don't miss important doses.
4. Notify Patients & Physicians: Develop a call list to efficiently notify patients and local doctors of a potential closure. This gives them time to make alternative medication arrangements.
5. Post Signage & Update Messages: Prepare clear signage indicating closure dates and times. Update voicemail messages to explain the situation.
6. Offer Prescription Transfers: Contact nearby pharmacies to see if they can take prescription transfers during a closure. This allows patients seamless access to their medications.

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We dive deep into 5 uses of  Ozempic, a drug known for managing diabetes, but with surprising potential beyond! Here are 5 intriguing uses you might not have heard of:

Liver Support: Early research suggests Ozempic could benefit liver health, but more studies are needed.
Weight Loss Weapon: Ozempic has a weight-loss version, offering a powerful tool many don't know exists.
Addiction Fighter: Ozempic might hold promise in combating alcohol and substance abuse (this one might surprise you!).
Heart Health Hero: Studies show Ozempic could help reduce the risk of heart problems.
Cancer Prevention & Treatment: Emerging evidence suggests Ozempic's potential role in preventing and treating certain cancers.
Alzheimer's Hope: Early research hints at Ozempic's possible use in managing Alzheimer's disease, although further investigation is crucial.

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Darshan explains  why you shouldn’t Trust Celebrities When Choosing Your Drugs!
Hidden Agendas: They're paid to promote, not give unbiased advice.
Not Medical Experts: Trust your doctor's knowledge, not a celebrity's opinion.
Oversimplified Info: 30-second ads can't tell the whole story.
Not Personalized: Your doctor can give you the right advice for your needs.
Ditch the Hype, Talk to Your Doctor!

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In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee.

Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-physicians handle the business side of a MedSpa, while a licensed physician oversees the actual medical services.

Points discussed: 

1. What are medspas?  
2. Different kinds of medspas  
3. How medspas are structured
4. Qualifications for running a medspa 
5. Services offered by medspas 
6. Can non-physicians run a medspa? 
7. Setting up a Management Service Organization (MSO) 
8. How can pharmacists get involved? 

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In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee .

Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-physicians handle the business side of a MedSpa, while a licensed physician oversees the actual medical services. 

What are medspas? 
Different kinds of medspas 
How medspas are structured
Qualifications for running a medspa 
Services offered by medspas
Can non-physicians run a medspa? 
Setting up a Management Service Organization (MSO) 
How can pharmacists get involved? 

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In this short, we explore four key reasons to get involved in clinical research.
First, it offers potential access to cutting-edge therapies, though it's important to note you might only receive the standard of care. 
Second, participation ensures closer monitoring by healthcare professionals. 
Third, it provides an opportunity to contribute to medical progress, benefiting others with similar conditions. 
Lastly, while financial compensation is a factor, it's controversial as it may impact informed consent. 

Tune in to hear more about these considerations and their implications.

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Today, we discuss four legal pathways to acquire unapproved drugs. 
First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph. 
Second, compounded drugs crafted by pharmacists provide an alternative despite lacking FDA approval.
Third, the FDA's new policy allows for state-imported drugs, provided certain protocols are adhered to. 
Lastly, individuals can legally import drugs for personal use from abroad within specified limits. 
For further insights, consult with legal and medical professionals. 

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We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use:

1. Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive compliance plan for AI use. Without clear goals, executing a successful strategy becomes challenging.

2. Establish Policies and Procedures: Clearly defined policies and procedures are necessary to understand and adhere to compliance standards. They provide guidelines for ensuring ethical and legal AI usage. 

3. Implement Training Programs: Training programs are essential for ensuring compliance with policies and procedures. They educate employees on AI usage protocols and help align their actions with organizational goals.

4. Conduct Continuous Quality and Audit Checks: Regular quality and audit checks are vital for ensuring adherence to policies, achieving goals, and maintaining ethical AI usage. Continuous monitoring helps identify and address any deviations from established guidelines.

 For assistance in aligning your marketing plan with AI use and ensuring compliance, feel free to reach out to us.

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In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse:

1. Verify the prescriber's identity.
2. Know the prescriber's DEA number.
3. Know your patient thoroughly.
4. Verify prescription dates for validity; ensure prescriptions are current.
5. Communicate directly with prescribers if any concerns arise.
6. Request identification when necessary.
7. Act decisively if fraud is suspected—never dispense suspicious prescriptions and report incidents promptly.
8. Recognize and report misuse patterns to appropriate authorities for swift action and prevention.

Tune in to DarshanTalks for more insights on healthcare compliance and safety.

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We discuss how to address drug shortages. First things first, it's important to stay calm. Just because there's a shortage doesn't mean you'll lose access to your medication entirely. Here are some action steps you can take: 

1. Schedule an appointment with your doctor to discuss alternative medications that might be effective for you. It's crucial to also talk about potential side effects and weigh the options together.

2. Pharmacies can be a great resource. They may have information on when your medication might be restocked or suggest similar drugs in the meantime.

3. Explore online FDA resources that track drug shortages. This way, you can stay updated on the situation.

Remember, communication is key. Talk with your doctor about any concerns and work together to find the best course of action. Stay informed and proactive in managing your healthcare.

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Drug accountability is a critical aspect monitored by the FDA at clinical trial sites. Principal investigators must maintain and document control over investigational products, ensuring they are only administered under direct supervision. Clinical research organizations also conduct routine audits to verify drug accountability. However, instances of improper disposal or false certifications have been identified, highlighting the importance of vigilance in maintaining accurate drug records. 

Compliance with drug accountability regulations is essential, as both the FDA and the Department of Justice oversee this area closely. 

For assistance with clinical trial compliance, reach out to us!

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In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance of compliance in avoiding legal pitfalls. Plus, learn valuable insights on the role of legal and compliance in navigating the complexities of ad promo. Don't miss out on this enlightening discussion! 

Points discussed:

1. How has the concept of regulatory evolved? 

2. Is legal essential in MLR? 

3. How do we define the roles of legal, compliance, and regulatory? 

4. How does a company's history and risk tolerance affect PRC committee interactions? 

5. How much flexibility should be given to regulatory consultants?

6. How to manage pushback within PRC team dynamics? 

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We discuss the risks associated with using AI in your pharma marketing plans: 

1.     Data Privacy and Security: Ensuring the security and privacy of data, whether it pertains to patients or non-patients, is paramount. 

2.     Bias: Questions arise regarding the sources of information, control over data, and addressing privacy concerns to prevent biases and comply with regulatory standards set by organizations like the FDA and FTC.

3.     Lacks Transparency: AI decisions must be transparent and understandable. Stakeholders need clarity on how decisions are made, and there should be traceability to ensure accountability and build trust in AI-driven processes.

4.      Intellectual Property Concerns: There are significant legal concerns surrounding intellectual property rights when using data to develop AI models. Lawsuits from entities like The New York Times or Google underscore the importance of protecting proprietary information and ensuring compliance with intellectual property laws.

5.     Consumer Protection: Implementing AI in marketing plans raises consumer protection issues. It's crucial to consider how AI-driven decisions may impact consumers and ensure that practices align with ethical standards and regulatory requirements to safeguard consumer interests.

By addressing these risks proactively, businesses can navigate the complexities of AI in marketing while minimizing potential pitfalls and ensuring compliance with legal and ethical standards.

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In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disruptions in menstrual cycles, violent episodes, or even deaths were not reported. While some cases were eventually identified, others went unnoticed, highlighting the importance of vigilant compliance. Sites should be aware that regulatory bodies like the FDA and DOJ closely monitor for such violations. 

Need assistance with your trial compliance? Reach out to Darshan at Darshan@kulkarnilawfirm.com. 

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In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure that patients' voices are not only heard but also central to decisions affecting their health. They play a crucial role in various aspects:

Firstly, patient advocates are instrumental in representing the patient voice in clinical trials. By advocating for patient-centric endpoints and highlighting symptoms that matter most to patients, they help ensure that trials are not only rigorous but also relevant to real patient needs.

Secondly, these advocates support the development and adoption of innovative drugs. They identify gaps in treatment options and advocate for the development of drugs that address unmet medical needs. By collaborating with pharmaceutical companies and healthcare providers, they advocate for the adoption of these drugs to improve patient outcomes.

Thirdly, patient advocates work tirelessly to ensure access to medications. They advocate for policies and practices that remove barriers to medication access, such as affordability and availability issues. By engaging with policymakers, healthcare providers, and the public, they strive to make sure that every patient can obtain the medications they need without undue hardship.

Moreover, patient advocates play a crucial role in healthcare decision-making processes. They participate in meetings with drug companies, hospitals, regulatory bodies, and government agencies to ensure that patient perspectives are considered in policy-making and healthcare delivery.

For those interested in becoming patient advocates, we discussed practical steps such as educating oneself on healthcare systems, clinical trials, and specific health issues, joining patient advocacy groups, attending conferences and workshops, volunteering, and sharing personal experiences to raise awareness.

In conclusion, patient advocates are instrumental in shaping a healthcare system that truly serves patients' needs. Their advocacy ensures that healthcare decisions are informed by patient experiences and priorities, ultimately leading to more effective, patient-centered care.

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We discuss how the shortage of chemotherapy drugs stems from economic challenges faced by generic drug manufacturers. Many cannot afford to produce these drugs due to low profitability. Factors include factory shutdowns for quality issues, a complex global supply chain, and older generic drugs being unprofitable to produce. Government pressure on prices further reduces profit margins, disincentivizing investment in production quality. Consequently, manufacturers prioritize newer, more expensive drugs, leading to treatment delays and stress for patients.

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Today, we're tackling a critical issue for restaurants and food marketers: promotional compliance and the risks of misbranding, as highlighted by a recent case in Biloxi. Mary Mahoney's Old French House Restaurant and its co-owner, Anthony Charles Savanovich, recently pled guilty to conspiracy and misbranding seafood. Over six years, they sold over 29 tons of fish fraudulently labeled as local premium species, when in fact, it was imported and frozen from Africa, India, and South America.

This case underscores the serious consequences of misrepresentation. Savanovich's guilty plea to a felony reflects the FDA's stance that such actions mislead consumers and pose health risks. For your restaurant or food marketing practice, any form of misbranding can lead to fines, recalls, and even criminal charges.

How can you protect your business? Ensure all promotional materials, from labels to advertisements, are truthful and compliant with food regulations. At the Kulkarni Law Firm, we specialize in FDA compliance, offering services such as promotional material review, compliance training, and legal guidance. Don't wait for legal issues to arise—take proactive steps to ensure compliance today.

Thank you for tuning in to this episode produced by DarshanTalks and powered by the Kulkarni Law Firm. 

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In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He emphasizes initiatives like the "Open Mic" policy for anonymous feedback and the grassroots movement Save Our Sites (SOS). Dr. Fox also explores issues with decentralized clinical trials, advocates for patient-centric practices, and underscores the roles of telehealth and AI in research, promoting transparency and ethical standards in clinical research operations.

1. What are the key challenges faced by clinical trial sites?
2. How can we ensure that sites have a platform to voice their concerns?
3. What is Save our sites?
4. Why SCOPE and ACRP may not be suitable platforms for sites?
5. How can we address the economics of running a conference when we do need people to buy those slots?
6. What is the incentive for individual sites to speak up?
7. The Decentralized Clinical Trials Controversy and Citizen Petitions
8. The role of Telehealth in Clinical Research
9. Does a DCT eliminate the need for localized PIs?
10. The Future of AI in Clinical Research

Check out Daniel Fox's websites:
CRPN- crpn.crpaynet.com
Save Our Sites- www.saveoursites.com

White paper- https://lnkd.in/ek9_NNT7

YouTube: @CRPNCentral 

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 In this episode, we discuss how drug and device manufacturers may seem to collaborate with telemedicine companies to market products and ensure patient needs are met conveniently. However, there are three major concerns:

1. Ignoring Pharma Laws: Telehealth companies might not adhere to pharma marketing laws and could act as agents for pharma due to developed relationships. This has drawn scrutiny from Congress, FDA, and FTC, raising concerns about potential non-compliance.

2. Inappropriate Product Sales: There are significant concerns about how telehealth and marketing companies are identifying patients. Inappropriate sales to patients who don't need the products have led to Department of Justice inquiries.

3. Signing Unnecessary prescriptions: Some telehealth companies use doctors to sign off on prescriptions for patients who may not need them, often influenced by kickbacks. This practice is highly problematic and may deter pharma companies from associations unless proper controls are in place.

For assistance with advertising compliance, reach out to us! 

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Edye Edens, a consultant and attorney with a background in regulatory affairs, shared insights into her unexpected yet exciting role at Weave, a rapidly growing startup specializing in AI-driven solutions for regulatory content creation. Edye discussed her journey from freelance consultancy to joining Weave, highlighting the unique challenges and opportunities this transition presented.

We discuss:

1.  Edye shares her journey of joining Weave

2. Leading the charge in hiring new talent

3. Dealing with competitors like Veeva

4. Building a culture of innovation at Weave

5. Managing Non-competition concerns

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In today's consumer landscape, privacy concerns reign supreme. Pharmaceutical and medical device manufacturers must prioritize meeting the expectations of this privacy-conscious generation. This begins with three key measures:

1. Consent Management: Clear communication about data usage is essential, aligning with regulations like CCPA and GDPR. Seeking user consent without relying on cookies is crucial.

2. Context-Based Information: Emphasize direct data collection from customers, in line with FTC guidelines. Implement opt-in provisions across all touchpoints to ensure explicit consent.

3. Robust Data Protection Practices: Ensure collected data meets regulatory standards, including FTC, GDPR, and CCPA requirements. Adhering to these standards is vital for maintaining trust and compliance.

By implementing these measures, manufacturers can navigate the evolving privacy landscape while building trust with consumers.

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Do dietary supplements interact with drugs? Many people think only prescription drugs can cause interactions, but dietary supplements can too. From an FDA perspective, a drug is defined by its claims and indications. Some supplements make drug-like claims and can interact with medications. Common examples include grapefruit juice and vitamin K, which often interact with drugs. Dietary supplements, like any food or drug, can cause interactions. Have you experienced a drug interaction from using a supplement? Tune in to the DarshanTalks podcast to learn more.

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Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs). 

PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-world setting. PMCs, while not legally mandated, are additional studies agreed upon by the drug developer, providing valuable insights.

Both PMRs and PMCs are essential for ensuring the safety and efficacy of medications. 

For clinical research sites, adhering to these protocols can be challenging but offers opportunities to showcase expertise and attract more research partnerships. 

For Sponsors: Sponsors must manage the costs and potential delays, but the insights gained can strengthen product value and regulatory trust. 

For CROs: CROs need to stay compliant and adapt to these requirements to secure lucrative collaborations.

Join us as we explore the latest FDA report and its implications for everyone in the clinical research arena. Don't miss out on understanding how these regulations shape the future of medical treatments and industry collaborations!

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Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promotional compliance within the pharmacy industry, and we're here to explore them in detail.
In a landmark case, the Department of Justice sentenced Richard Hall, a 53-year-old pharmacy owner from Fort Worth, to several years in prison. The charges? Hall paid illegal kickbacks to patient recruiters and physicians, leading to unnecessary prescriptions and defrauding federal healthcare programs. Court documents and trial evidence revealed that Hall, along with others, created and marketed expensive compounded medications. These medications, meant to be custom-tailored to individual patient needs, became the focal point of the fraud. Hall paid marketers to recruit doctors to write prescriptions for these costly compounded medications, offering "investment opportunities" that allowed the doctors to profit from the pharmacy operations. Furthermore, Hall engaged in a conspiracy to launder the unlawful proceeds of this scheme.
The Anti-Kickback Statute is explicit – financial incentives should never influence healthcare decisions. Yet, Hall crossed this line, resulting in severe legal consequences. This case was not just about kickbacks; it also involved money laundering to conceal the origins of the illicit funds. Such actions undermine the integrity of the healthcare system and highlight the critical need for strict compliance with legal and ethical standards.
This scandal emphasizes the importance of ensuring that: Every prescription dispensed is medically necessary and appropriately documented. As pharmacists and pharmacy marketers, it is our duty to prioritize patient care and uphold the highest ethical standards. The ramifications of failing to do so can be devastating, both legally and professionally.
So, what steps can you take to avoid similar pitfalls? First, steer clear of any financial incentives that could be construed as kickbacks. Second, ensure that every prescription is justified by medical necessity. Third, closely monitor financial transactions to ensure they comply with all legal requirements.

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