Article Summary:
This week, the FDA was able to resume some operations after the government shutdown ended, allowing it to start accepting submissions requiring fees again. Significant personnel changes occurred, with Richard Pazdur being named the new director of the Center for Drug Evaluation and Research, replacing George Tidmarsh. According to sources, FDA Commissioner Makary personally persuaded Pazdur to accept the position.
The legislation to reopen the government allocated $6.957 billion in funding for the FDA in fiscal year 2026, which is more than the administration’s proposed budget cuts. This includes $1.17 billion specifically for the agency’s foods program. Additionally, the FDA released guidance on pH adjusters in generic drug applications and qualified a new biomarker to detect drug-induced liver injury.
The text also reports on controversies at the agency. Two top FDA officials are said to be “quietly upending” vaccine regulations, with one proposing to change labeling to say the risks outweigh benefits for certain age groups. Additionally, the deputy director of the Office of Vaccines has reportedly resigned.
Elsewhere, the HHS Secretary is navigating a potential conflict after the administration announced a price-cutting deal for obesity drugs, in contrast with the Secretary’s previous criticism of such medications. On the product approval front, the FDA greenlit several new drugs and medical devices, including an interchangeable biosimilar to the breast cancer drug Perjeta.
Overall, the summary covers a range of regulatory, personnel, and product updates at the FDA during this eventful week.