DarshanTalks Podcast

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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 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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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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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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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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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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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 [email protected]

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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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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 [email protected]

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