DOJ's "Get Out of Jail Free" card for pharma and device mergers?
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.