DarshanTalks Podcast
Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
🔒 Trump’s Bold Picks Shake Up Life Sciences
Subscriber-only episode
The Trump administration’s new appointees, including Elon Musk, Dr. Marty Makary, Dr. Jay Bhattacharya, and Robert F. Kennedy Jr., promise a significant shift for the life sciences industry. Each brings a disruptive approach to their respective agencies, signaling potential changes in clinical research, drug advertising, and regulatory oversight.
Key highlights:
Elon Musk will lead the Department of Government Efficiency, introducing innovation-focused reforms that could streamline processes but heighten accountability.Dr. Marty Makary at the FDA might push for more transparency in clinical trials and pa...🔒 3 Regulatory Opportunities in Clinical Trials!
Subscriber-only episode
We explore the rapidly evolving role of artificial intelligence (AI) in clinical trial research design. He discusses how AI is reshaping the pharmaceutical landscape and highlights key areas identified by the FDA where AI is expected to make a significant impact.
Darshan delves into the transformative power of digital health technologies, which enable real-time patient monitoring and enhance adherence to treatment protocols. These technologies not only improve patient safety but also provide critical data that can refine trial outcomes.
The e...
Don't Take Non-Prescription Ozempic or other Weight Loss Drugs
We explore the emerging trend of patients bypassing traditional healthcare to obtain weight loss medications like Ozempic through unofficial channels and telehealth platforms. This underground movement raises serious ethical and legal concerns, as individuals manipulate systems to access these drugs without proper prescriptions, risking their health and undermining physicians' reputations.
Recent reports from The Atlantic and ABC News highlight the rise of "OZIC hackers" and Eli Lilly's decision to sell its new weight loss drug, Z-bound, directly to consumers. While this shift aims to increase accessibility, it poses significant risks...
Clinical Trial Principal Investigator Duties in Clinical Trials
The FDA has stressed the critical importance of adequate supervision and monitoring in clinical trials to ensure they are conducted properly. A key figure responsible for this oversight is the Principal Investigator (PI), as outlined in 21 CFR 32.6. The PI must ensure the trial follows the protocol and all applicable regulations, and that the rights, safety, and welfare of the trial participants are protected, including obtaining informed consent.
Consistently, the FDA has raised concerns about two major areas:
1. Drug Control: Investigators are required to maintain control and proper documentation of the...
Supreme Court Redefined Pharma Marketing Rules
The Supreme Court's ruling in Loper Bright Enterprises v. Raimondo significantly impacts off-label marketing for pharmaceutical and medical device companies by challenging the FDA's authority to restrict off-label speech. This decision is poised to reshape the regulatory landscape that has traditionally limited such communications.
Key Legal Context:
- Historically, the FDA has prohibited off-label promotion based on misbranding statutes, which require drug and device labeling to specify only FDA-approved uses. This has left off-label uses outside compliant labeling.
- The FDA's argument that promoting off-label uses...
AI concerns in M&A for Life Sciences
Artificial intelligence (AI) is transforming the life sciences sector, offering groundbreaking advancements in areas like drug discovery, clinical trials, and personalized patient care. As AI-driven technologies become more integrated into these processes, the allure of acquiring AI-powered companies grows stronger. However, the complexities that come with AI introduce significant risks, especially when it comes to mergers and acquisitions (M&A). Life sciences attorneys must move beyond just understanding AI technology—they need to be deeply familiar with the regulatory, ethical, and legal intricacies that AI introduces in these transactions.
At the heart of successful M...
Trump Teams Potential Changes to Healthcare
Healthcare and life sciences are on the brink of transformative change, fueled by a combination of technological innovation, ideological shifts, and evolving regulations. Visionaries like Elon Musk, Vivek Ramaswamy, and RFK Jr. are advocating for decentralization in healthcare, pushing for more personal control over patient data. While decentralization promises to reduce federal oversight, potentially lowering compliance costs and streamlining operations, it also raises serious concerns about the security and privacy of health data. Weakened federal regulations like HIPAA could lead to increased risks of data breaches and misuse, and state laws may not be enough to fill the gaps.<...
🔒 Can AI Rewrite the Rules of Clinical Trials?
Subscriber-only episode
In this episode, we're diving into the intersection of technology and healthcare, specifically the role of Artificial Intelligence (AI) in clinical trials. As a Food and Drug lawyer, Darshan has seen firsthand how AI is revolutionizing drug development and testing. The FDA is closely monitoring this shift, recognizing the potential of AI to enhance patient outcomes, improve trial efficiency, and reduce costs.
However, it’s not all smooth sailing. AI can help identify the right patients for specific treatments, but it’s crucial to address potential biases in AI algorithms, whic...
Ad Promo Review in Pharma - How Far is Too Far?
Katie Graham and I discuss various aspects of FDA and FTC regulations, including ad promo, the Chevron decision, and the evolving role of compliance in the pharmaceutical industry.
Key topics include:
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Why Staff Training Problems are a liability for Your Clinical Trial site
Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, instances have emerged where this responsibility was neglected.
In one notable case, PIs were prosecuted due to inadequate training and oversight of research staff. Study coordinators, often without relevant research experience and from low-wage backgrounds, were left to manage studies without proper guidance. This lack of training led...
