US FDA
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.
Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.
Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.
HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.
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 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.
The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.
Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.
Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
One CDRH employee said the cuts already are having a major effect on morale.
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.