United States: Food, Drugs, Healthcare, Life Sciences

Congress returns for a legislative sprint focused on healthcare policy, with committees examining physician payment reform, cybersecurity protections, and healthcare fraud. Meanwhile, federal agencies advance major initiatives including FDA leadership changes, CMS actions against fraudulent medical equipment suppliers, and new biosafety oversight requirements for NIH-funded research.

The US Drug Enforcement Administration has submitted a final telemedicine special registration rule for review, potentially establishing a long-awaited pathway for telehealth prescribing of controlled substances. This development comes after more than 16 years since the Ryan Haight Act required such a process, with current telemedicine flexibilities set to expire on December 31, 2026.

President Trump has nominated Dr. Heidi Overton to lead the FDA, bringing a policy expert with experience in medical marijuana reform, vaccine policy, and drug access initiatives. Her prior positions on mifepristone regulation, childhood vaccination schedules, and pharmaceutical innovation offer insight into potential agency priorities. The nomination faces a contested Senate confirmation process as stakeholders assess how her health policy background may shape FDA's regulatory approach.

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.

Life sciences M&A activity surged in the first half of 2026 with 86 transactions totaling $196 billion, marking a 141% increase over the previous year and the strongest start since 2019. The resurgence is driven by an impending patent cliff threatening $305 billion in revenue, abundant dry powder on pharma balance sheets, and attractive target valuations. With companies increasingly focused on de-risked Phase II and beyond assets, and private equity emerging as optimization partners, the industry is positio

Representatives Bob Latta and Debbie Dingell have introduced the BEDROCK Act, legislation aimed at strengthening American biomanufacturing competitiveness and reducing dependence on China. The bill would designate a Commerce Department official to lead efforts, assess supply-chain vulnerabilities, develop action plans, and streamline federal commercialization processes to help scale domestic production of biologically-manufactured products.

An HHS Office of Inspector General audit of Methodist Hospital in San Antonio reveals how a review of just 100 claims led to a $12.4 million overpayment recommendation through statistical extrapolation. The audit targeted specific high-risk billing areas including Inpatient Rehabilitation Facility claims, certain diagnosis-related groups, and outpatient billing patterns, uncovering documentation and coding compliance issues that hospital leadership should examine within their own Medicare claims.

Congress returns for a legislative sprint focused on healthcare policy, with committees examining physician payment reform, cybersecurity protections, and healthcare fraud. Meanwhile, federal agencies advance major initiatives including FDA leadership changes, CMS actions against fraudulent medical equipment suppliers, and new biosafety oversight requirements for NIH-funded research.

A landmark Sixth Circuit ruling establishes that Medicare providers who reasonably interpret coverage requirements and submit claims in good faith may not be required to refund payments, even when services are later deemed noncovered. This decision fundamentally changes how Medicare coverage appeals should be approached and provides new protections for providers facing post-payment reviews.