DarshanTalks Podcast

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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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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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&A due diligence involving AI companies lies a deep dive into regulatory compliance. Life sciences is one of the most heavily regulated industries globally, and AI technologies operating within this space must comply with laws such as FDA guidelines, GDPR for data privacy, and HIPAA for patient data protection. Failing to evaluate the target company’s compliance with these regulations can lead to severe penalties and jeopardize the entire deal. Attorneys must ensure that AI systems are compliant to avoid unexpected liabilities post-acquisition.

Another critical area is intellectual property (IP). AI-driven companies typically possess valuable assets, such as proprietary algorithms and data models, but ownership of these assets is not always clear-cut. Life sciences attorneys need to thoroughly review the IP portfolio to ensure full ownership and absence of any disputes or pending litigation. Overlooking these issues can result in future challenges, potentially devaluing the acquisition. Partnering with experienced IP counsel during the due diligence process is crucial to securing a clean and clear transfer of assets.

Data integrity and security are also paramount in AI-driven life sciences companies. AI is only as good as the data it is trained on, and flawed or biased data can lead to catastrophic outcomes, especially in critical areas like patient care. Attorneys must assess the quality, source, and security of the data, ensuring that robust security measures are in place to protect sensitive patient information. This is non-negotiable in a sector where data breaches or flawed AI outcomes can lead to massive financial and reputational damage.

Lastly, ethical considerations must be part of the M&A conversation. AI systems in life sciences raise issues of transparency, accountability, and bias, and attorneys must evaluate whether the target company adheres to ethical standards. This includes ensuring human oversight over AI decisions and preventing biased outcomes that could lead to discriminatory practices. Failing to address these ethical considerations could harm the acquiring company’s reputation and market standing in a sector where trust is paramount.

In conclusion, while AI holds immense potential in life sciences, the risks associated with acquiring AI-driven companies cannot be ignored. Thorough due diligence—covering regulatory compliance, intellectual property, data integrity, and ethical considerations—is essential to a successful M&A transaction. The Kulkarni Law Firm, with its deep understanding of both AI technology and the life sciences regulatory landscape, is uniquely positioned to guide companies through these complex processes, ensuring that all risks are identified and managed effectively. For those seeking expert legal advice on AI-driven M&A, the Kulkarni Law Firm is your trusted partner. Reach out to us today to safeguard your business objectives and ensure a smooth and compliant acquisition.

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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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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 to errors and potential fraud, highlighting a crucial gap in compliance.

Ensuring that all research staff are properly trained is essential for the integrity of clinical trials. If you need help developing a robust clinical research program, reach out to me.

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