Article Summary:
This week’s FDA update covers a range of regulatory issues and developments. The main focus is on the Commissioner’s National Priority Voucher (CNPV) program, which has raised concerns among FDA officials and the industry. The program aims to prioritize the review of drugs deemed critical to national security, potentially shortening their review times. However, unnamed officials have expressed worries that this may be illegal, unethical, and could lead to a disregard for the agency’s scientific standards. There are also reports of delays in the review of two drugs that are part of the CNPV program due to safety concerns.
In other news, Republican lawmakers are calling for restrictions on the use of the abortion drug mifepristone, arguing that it should only be prescribed based on in-person visits. Meanwhile, the Department of Health and Human Services has appointed two OB/GYNs with histories of opposing vaccines and antidepressants to the CDC’s Advisory Committee on Immunization Practices.
The FDA has also requested the removal of information about the risk of suicidal ideation and behavior from the labeling of certain glucagon-like peptide-1 (GLP-1) receptor agonist drugs, and it has been reported that the agency quietly deleted a webpage listing unproven and bogus autism treatments.
Additionally, the FDA has published updates to its Standard Operating Policy and Procedure manuals for the administrative processing of clinical holds and IND applications, and has approved the first treatment for Menkes disease in children.