FDA should be able to establish a priority review process for generic drugs where there is minimal price competition for an off-patent drug, Gerard Anderson, professor of health policy and management at Johns Hopkins University, told the Senate Special Committee on Aging at a Dec. 9 hearing.
FDA Priority Review For Some Generics Urged To Address 'Market Failure'
Senate Aging Committee hearing addresses generic drug priority reviews at FDA, compounding and publicizing a “watch list” of off-patent drugs with no competition as ways of deterring dramatic price increases for such products.
More from United States
Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.
The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.
The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.
The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
More from North America
Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.