FDA Policy Tracker: 2025 Was a Year of Change
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring…
From the Biotech Insider archive. This article dates from Dec 30, 2025 and is preserved as first published.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
From vaccines to rare diseases and the phasing out of animal testing requirements, it was a busy year for biopharma on the policy front as Health Secretary Robert F. Kennedy Jr. and his team at HHS made their mark on the FDA, CDC and National Institutes of Health.
Many of the FDA’s 2025 guidances have focused on accelerating the path of cell and gene therapies to the market—particularly those intended for rare and ultrarare diseases. In a year where controversy is almost expected with every news announcement, the need for more and more-effective therapies for rare conditions may be the one area on which Americans of every political stripe can agree.
Analysts and other FDA watchers who spoke with BioSpace see the momentum generated in this area in 2025 continuing into the new year. “I do think that, given what we’re seeing from FDA, rare orphan diseases as an area” of great interest for biopharma and investors will persist into 2026, Graig Suvannavejh, managing director of Equity Research at Mizuho Securities, told BioSpace. Married with reports that the FDA will soon begin requiring only one pivotal trial as opposed to the standard two, “this would make it seem ripe for rare orphan [diseases],” he added.
Analysts and other FDA watchers who spoke with BioSpace see the momentum generated in this area in 2025 continuing into the new year.
Another key area of focus for the HHS under Kennedy—with his long history of antivaccine activism—has been in the vaccines space. On April 30, the Health department announced it would require all new vaccines be tested in placebo-controlled trials before they are approved, a “radical departure” from past practices, an HHS spokesperson told The Washington Post at the time. Earlier this month, Kennedy’s reformulated CDC Advisory Committee on Immunization Practices made another radical departure from the norm, voting to delay the hepatitis B vaccine from birth to two months of age for some infants.
“Obviously [Kennedy is] driving a lot of this, from vaccine policy to staffing and everything like that,” Chad Landmon, Hatch-Waxman & Biologics chair at Polsinelli Law Firm, told BioSpace, “so I think it’ll be interesting to see how that continues, whether the same people continue in those roles.”
BioSpace has compiled a review of our coverage of this year’s key policy initiatives. We will continue to update this tracker as we move into 2026 and see what comes next.
