The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”
A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors.
The U.S. FDA’s device guidance drought ended with the issuance of one draft and one final guidance, the latter of which deals with the Q-sub program for early interaction with sponsors of device applications. Per a request by industry, the agency indicated it is amenable to including FDA policy staff during these meetings, which may help to avoid surprises in premarket applications.
The funding boost Moderna Inc. had expected via a roughly $590 million Biomedical Advanced Research and Development Authority award now looks to be off the table. The company disclosed May 28 that the U.S. Department of Health and Human Services (HHS) said it will terminate the award for late-stage development and right to purchase pre-pandemic influenza vaccines.
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
The U.S. Trade Representative (USTR) is asking for help in its search for “freeloaders” that refuse to shoulder their share of the cost of biopharma R&D.
The controversy over budget scoring by the Congressional Budget Office (CBO) once again prompted legislation that would overhaul the membership of a health advisory panel that may affect legislation dealing with the Medicare program. The Health Panel Act of 2025 requires the panel be composed of six members each appointed by Republicans and Democrats. The bill's sponsor said this is crucial to ensure diversity of political views, which is said to be lacking as the panel is currently constituted.
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
The U.S. Department of Health and Human Services (HHS) put biopharma companies on notice May 20: It’s time to commit to reducing prescription drug prices to reflect most-favored-nation (MFN) pricing in accordance with President Donald Trump’s May 12 executive order. HHS said it expects manufacturers to commit to aligning their U.S. prices for all brand products across all markets that don’t currently have generic or biosimilar competition with the lowest price of a set of economic peer countries.
Recognizing the potential legal challenges to U.S. President Donald Trump’s executive order calling for most-favored-nation (MFN) prescription drug pricing and the limits of that order, several congressional Democrats introduced a bill in both the House and Senate May 14 that could make MFN pricing the law of the land and extend it to both government health programs and private insurance.
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