Lawmakers are pressing the FDA for answers about its Commissioner’s National Priority Voucher program, voicing concerns over potential corruption, safety risks and transparency issues.
In a Nov. 20 letter to FDA Commissioner Martin Makary, MD, and HHS Secretary Robert Kennedy Jr., Rep. Frank Pallone Jr. and Sen. Bernie Sanders questioned the legal basis and implementation of the initiative, which has granted 15 expedited review vouchers since June. The FDA awarded nine vouchers in October, followed by six more on Nov. 6.
Launched June 17, the program aims to accelerate drug reviews for products tied to “U.S. national interests,” reducing approval timelines from 10 to 12 months to as little as one or two. The program uses a team-based review process that includes a pre-review phase and a one-day decision meeting.
Drugs selected so far include therapies for vaping cessation, Type 1 diabetes, sickle cell disease, tuberculosis, obesity and multiple cancers. Four of the nine initial voucher recipients told lawmakers they had not applied for the voucher and were “surprised” to be chosen, according to the lawmakers’ letter.
Mr. Pallone and Mr. Sanders wrote that the compressed timelines could compromise drug safety, particularly as the agency faces staffing shortfalls.
