House lawmaker raises new concerns over FDA’s ultra-fast drug review program

A Democratic lawmaker has raised significant concerns about a controversial Food and Drug Administration program designed to fast-track certain drug approvals, questioning both its transparency and legal foundation.

In a letter sent Tuesday, Representative Jake Auchincloss of Massachusetts criticized the FDA’s Commissioner’s National Priority Voucher program, which promises expedited reviews of one to two months for new medicines deemed to support “national interests.” The program stands at the center of FDA Commissioner Marty Makary’s initiative to reduce bureaucratic processes at the agency.

Auchincloss, who serves on a House health subcommittee, contends that details about the program have been “shrouded in secrecy,” pointing to the FDA’s failure to respond to multiple congressional inquiries.

“The public must have transparency about the ‘voucher’ program, under which drug approvals have been made almost wholly and in an unprecedented manner by the FDA’s political leadership,” Auchincloss wrote in his letter.

His concerns emerged on the same day the FDA conducted an employee town hall on the program, according to three agency staffers who spoke to The Associated Press anonymously. Much of the internal debate centers on worries that drug decision-making authority is being shifted away from career scientists to political appointees.

During Tuesday’s town hall, FDA leadership sought to reassure staff that final approval decisions would remain with drug center professionals. “The approval decision remains with the relevant product center, using the center’s normal processes,” stated presentation materials shared with the AP.

A major point of contention raised by Auchincloss involves the lack of publicly available financial disclosure forms for eight senior FDA officials who determine which drugs receive priority vouchers. The committee’s membership, first reported by Stat News, largely consists of officials aligned with Health Secretary Robert F. Kennedy Jr., including Deputy FDA Commissioner Dr. Sara Brenner, vaccine oversight director Dr. Vinay Prasad, and FDA drug center director Dr. Tracy Beth Hoeg.

These financial disclosure forms, collected annually by the Office of Government Ethics, are designed to reveal investments, outside income, and other financial details for senior officials and their spouses – information crucial for identifying potential conflicts of interest, especially in an agency regulating multibillion-dollar companies.

The lawmaker also questioned whether the FDA possessed legal authority to establish the voucher program without congressional action, which typically authorizes such initiatives through legislation. According to Auchincloss, the FDA’s legal office “was not consulted nor provided findings to support the agency’s claim” that it could independently create the program.

This legal uncertainty has reportedly led several senior FDA staffers to decline signing off on drug approvals processed through the program, as previously reported by the AP.

The letter from Auchincloss follows previous unanswered inquiries. In November, Senator Bernie Sanders of Vermont and Representative Frank Pallone of New Jersey, the top Democrat on the House Energy and Commerce Committee, sent a letter containing 15 questions about the program. According to a committee staffer, the agency has not responded to that inquiry either.

The Department of Health and Human Services did not immediately respond to AP’s questions about Auchincloss’s letter.

The scrutiny highlights growing tension between political appointees and career scientists at the FDA, an agency traditionally known for its rigorous, science-based approval processes. Critics worry that expedited approvals without proper scientific review could potentially compromise drug safety and efficacy standards that have been the hallmark of FDA’s reputation.

Industry observers note that while reducing unnecessary regulatory burdens remains a worthwhile goal, maintaining the scientific integrity of the approval process is essential to preserve public trust in FDA-approved medications and treatments.