‘A slow-moving catastrophe’: What we heard at the Biopharma Congress At this week’s Biopharma Congress in Washington, former FDA officials and industry leaders gathered to discuss the agency’s current turmoil, touching on workforce cuts and potential reorganizations. A rare bright spot: The first in a new series of rare disease workshops is expected to be…
Right off the bat, the high-profile departure of Peter Marks, M.D., Ph.D., former director of the FDA’s Center for Biologics Evaluation and Research, was linked to his advocacy for vaccines, which opposes certain viewpoints held by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. Now, Marks is making it clear: His…
In the latest of a string of clawbacks, the Department of Health and Human Services (HHS) is now sharing plans to cut contract spending by 35% across all divisions. “Every agency within HHS is committed to reducing contract expenditures by this target,” an HHS spokesperson told Fierce Biotech. “These cuts are designed to ensure that…
Amy Comstock Rick joined the FDA last November, and she not only survived the widespread staff cuts last week, she’s one of only a handful of FDA officials to speak at a live conference since the Trump administration took over. Rick told a crowd of mostly pharma industry employees and analysts at the Biopharma Congress…
Layoffs and other staff reductions at the US Food and Drug Administration are a “slow-moving catastrophe” that will undermine drug approvals in subtle ways, former Principal Deputy Commissioner Janet Woodcock said. The “whole apparatus to get a drug on the market has been undermined,” Woodcock said 7 April at the Biopharma Congress, presented by Prevision…
As President Donald Trump’s massive overhaul of federal agencies continues, several former FDA officials spoke about the potential ramifications for drug reviews and provided a look inside current FDA conditions. “Leadership in the agency’s been decapitated, and I think that was somewhat deliberate,” Janet Woodcock, M.D., former acting FDA commissioner and former principal deputy commissioner of…
A federal judge in Texas quashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds. “The Court VACATES and SETS ASIDE, in its entirety, the FDA’s Final Rule titled Medical Devices; Laboratory Developed Tests,” the ruling reads.…
The Food and Drug Administration’s top vaccine official, Dr. Peter Marks, resigned under pressure Friday and said that Health Secretary Robert F. Kennedy Jr.’s aggressive stance on vaccines was irresponsible and posed a danger to the public. “It has become clear that truth and transparency are not desired by the secretary, but rather he wishes…
When newly confirmed US Food and Drug Administration Commissioner Martin Makary enters the halls of a newly-crowded White Oak on 27 March, all eyes will be watching for whether he leans in to the Trump Administration’s actions that destabilized the agency or changes course to reinvigorate morale. The Senate voted 56-44 on 25 March to…
Stakeholders want the US Food and Drug Administration (FDA) to consolidate its accelerated approval guidances. They also asked for clarification about when the agency considers a confirmatory trial to be underway and acceptable trial benchmarks. In January, FDA proposed a guidance that would hold sponsors of drugs with accelerated approval more accountable for conducting confirmatory…
