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From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of sound bites, featured two standout sessions: Food and Drug Administration (FDA) Commissioner Dr. Martin A. Makary on Day 1 and Congressman (D-Mass) Jake Auchincloss on Day 2. Their talks, of course, revealed stark differences in approach—Dr. Makary’s forward-looking optimism and Mr. Auchincloss’s calls for concern—yet shared a commitment to advancing innovation and protecting the core of the agency. To be sure, much of what was said (aside from Dr. Makary’s now widely reported-on comment about a new vaccine framework) was not new, but there are a number of industry takeaways when viewed together and in the context of the conference itself.Continue Reading Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

As the spring conference season winds down, there was one topic that remained top of mind. At the Food and Drug Law Institute (“FDLI”)’s Annual Conference on May 17-18, 2023, the U.S. Department of Justice (“DOJ”)’s Consumer Protection Branch (“CPB”), and the Food and Drug Administration (“FDA”) continued the discussion surrounding each agency’s approach to the CPB’s new Voluntary Self-Disclosure Policy for Business Organizations (“Voluntary Self-Disclosure Policy”). The Voluntary Self-Disclosure Policy responds to Deputy Attorney General Lisa Monaco’s September 2022 memorandum (the “Monaco Memo”), which directed all DOJ components that prosecute corporate crime to review or issue new written policies on corporate self-disclosure of criminal misconduct. The Monaco Memo, in turn, reflects the DOJ’s continued efforts to increase transparency and predictability for companies deciding whether to self-disclose misconduct. The DOJ’s continued efforts led the Criminal Division to announce its Corporate Enforcement and Voluntary Self-Disclosure Policy (“Criminal Division Policy”) in January 2023, and several other DOJ branches and divisions, including CPB, have followed suit, borrowing from the Criminal Division’s guidance while tailoring their policies to the specific matters within their jurisdiction. As part of the FDLI panel discussion, CPB and FDA provided their perspectives on the new CPB policy, discussed best practices to implement, and emphasized questions to ask and answer in the evaluation of a company’s compliance program.Continue Reading DOJ Continues to Discuss Updates to Compliance Program Guidance and Corporate Enforcement Policies