Food, Drugs, Healthcare, Life Sciences

Expert testimony is often the center of gravity in life sciences and technology disputes because patent, licensing and other commercial cases often turn on specialized scientific or technical questions. Yet the traditional method of presenting expert testimony—one side presents its expert, the expert is examined and cross-examined and, days later, the opposing expert goes through the same process—is not always well suited to resolving these questions. By the time the second expert addresses a point made by the first, the tribunal is comparing testimony delivered at different times, in response to different questions and sometimes using different terminology or assumptions. And much of what the experts have to say is really not in dispute.

On September 18, 2026, the Department of Justice (DOJ) announced revisions to the Justice Manual formalizing two significant changes to False Claims Act (FCA) enforcement policy. First, DOJ reestablished and enhanced a prior policy providing that alleged noncompliance with nonbinding agency guidance documents cannot establish civil FCA liability. Second, when making a declination decision, DOJ attorneys "will in each case" assess whether to seek dismissal.

Recent developments in patent law are creating significant uncertainty for life sciences companies. The USPTO's evolving stance on obviousness-type double patenting, increasingly stringent enablement requirements following Amgen v. Sanofi, and the Supreme Court's clarification of skinny-label protections in Hikma v. Amarin are fundamentally reshaping how pharmaceutical and biotechnology companies must approach patent strategy and generic competition.

On September 18, 2026, the Department of Justice (DOJ) announced revisions to the Justice Manual formalizing two significant changes to False Claims Act (FCA) enforcement policy. First, DOJ reestablished and enhanced a prior policy providing that alleged noncompliance with nonbinding agency guidance documents cannot establish civil FCA liability. Second, when making a declination decision, DOJ attorneys "will in each case" assess whether to seek dismissal.

The FDA's September 2026 warning letter to Empower Pharmacy reveals critical enforcement priorities surrounding compounded semaglutide and tirzepatide, particularly regarding prescriber determinations of "significant difference" under Section 503A. This detailed analysis examines how prescription documentation, production volumes, and third-party prescribing platforms factor into FDA's scrutiny of whether compounded GLP-1 medications qualify for statutory exemptions.

The U.S. Food and Drug Administration has unveiled the final design of its Expedited Investigational New Drug Pilot Program, opening applications for sponsors and Qualified Research Institutions through October 2026. The FDA plans to select eight to 10 sponsor-QRI pairs for the initial pilot cohort by December 2026, marking a significant development in the drug approval process.

The FDA has escalated enforcement against online peptide sellers through warning letters and criminal prosecution, while state medical boards impose stricter standards on prescribers. Recent actions reveal how research-use-only disclaimers fail when evidence shows intended human use, and one case resulted in a 70-month prison sentence combined with $5 million forfeiture.

Recent developments in patent law are creating significant uncertainty for life sciences companies. The USPTO's evolving stance on obviousness-type double patenting, increasingly stringent enablement requirements following Amgen v. Sanofi, and the Supreme Court's clarification of skinny-label protections in Hikma v. Amarin are fundamentally reshaping how pharmaceutical and biotechnology companies must approach patent strategy and generic competition.

The FDA's September 2026 warning letter to Empower Pharmacy reveals critical enforcement priorities surrounding compounded semaglutide and tirzepatide, particularly regarding prescriber determinations of "significant difference" under Section 503A. This detailed analysis examines how prescription documentation, production volumes, and third-party prescribing platforms factor into FDA's scrutiny of whether compounded GLP-1 medications qualify for statutory exemptions.