Article Summary:
The FDA has been busy with several regulatory updates and initiatives this week. A new analysis revealed the extent of staff reductions at the Department of Health and Human Services (HHS) under the Trump administration, with over 20,500 employees – around 18% of the workforce – either fired or leaving since January 2017.
FDA Commissioner Marty Makary stated the agency is reviewing applications for its new Commissioner’s National Priority Voucher (CNPV) pilot program, which aims to accelerate the review of certain products. The agency also announced a public meeting to discuss performance metrics and resource capacity planning for its various user fee programs.
The FDA is facing growing public mistrust, with hundreds of HHS employees accusing Robert F. Kennedy Jr. of sowing distrust in the CDC and fueling the recent attack on its headquarters. Meanwhile, the White House plans to impose low tariff rates on generic drug imports from the EU.
On the drug and biologics front, the FDA approved Ionis Pharmaceuticals’ Dawnzera, the first RNA-targeted drug for hereditary angioedema. The agency also extended target action dates for two Eylea applications due to manufacturing concerns. Additionally, the FDA announced plans to host workshops on patient experience data and its proposed PreCheck program to boost domestic drug manufacturing.