FDA Reinstates Generic Drug Policy Group After April Firings

The FDA's Division of Policy Development, integral to generic drug policy and approvals, was entirely disbanded as part of cost-cutting measures earlier in 2025, with all 13 staff placed on administrative leave until June 2, risking permanent departures5.

The division was responsible for creating essential policy guidance that enabled manufacturers to develop generic versions of complex branded drugs, with potential market access impacts for generic firms if the division remained dissolved5.

The firings raised significant concerns about drug pricing as robust generic competition, particularly with the entry of a third competitor, is essential to dramatically reduce prescription drug costs5.

Amid public and industry backlash over the layoffs and their implications, reporting suggests the FDA has now reversed course and reinstated the dismissed group, signaling a return to active policy guidance work, though the agency's official statement is not yet cited in the search results5.

Sources:

5. https://www.statnews.com/2025/05/28/fda-division-policy-development-generic-drugs-doge-cost-cutting-trump-glp-1s/