This May, the food and drug law community gathered at an annual conference hosted by the Food and Drug Law Institute (“FDLI”) in Washington DC. The agenda featured speakers across the agency, including former Commissioner Makary, current Acting FDA Commissioner
In a joint motion filed February 5th with the U.S. District Court for the District of Maine, the U.S. Department of Health and Human Services (“HHS”) stated that it would terminate its current 340B Rebate Pilot Program (the “Program”), which
The U.S. Food and Drug Administration (FDA) recently updated two guidance documents applicable to wearable devices and guidance for clinical decision support tools, continuing the agency’s efforts to ease regulatory hurdles for digital health tools and potentially the use of
The Indiana Department of Health recently approved a major hospital merger in Terre Haute between Union Health and HCA Healthcare’s Terre Haute Regional Hospital. Under traditional antitrust analysis, the transaction is the kind of horizontal consolidation that would raise serious
For many health care organizations, including hospital systems, physician groups, and private equity–backed health care platforms, board and governance structures have grown increasingly complex as the industry consolidates and integrates across service lines. It is common for executives, physicians, and
The 2025 U.S. government shutdown kicked in effective at 12:01am, October 1, 2025, and as of this posting, has been in place for over a week. The shutdown will continue indefinitely until Congress unifies and resolves the budget impasse.
The
What happened. On September 10, 2025, the FTC announced it sent warning letters to a number of healthcare employers and staffing firms about potentially unlawful non-compete provisions, signaling the agency’s renewed focus on labor restraints in healthcare. The letters urge
On July 31, 2025, the U.S. Department of Health and Human Services Health Resources and Service Administration (HRSA) announced the availability of a new 340B Rebate Model Pilot Program (the Rebate Pilot Program). Under this Rebate Pilot Program, instead of
Amedisys, a major provider of home health and hospice care, has agreed to pay a $1.1 million civil penalty to settle allegations that it violated the Hart-Scott-Rodino (HSR) Act during the antitrust review of its pending $3.3 billion acquisition by
On May 12, President Trump signed an executive order entitled “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” (the “Order”). At the core of the executive order is a commitment to most-favored nation (“MFN”) pricing for drugs
