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

By MATTHEW PERRONE

WASHINGTON (AP) — A Democratic lawmaker raised new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs, including whether senior officials involved in the effort are complying with federal ethics rules.

In a letter sent Tuesday, Rep. Jake Auchincloss of Massachusetts took issue with the lack of transparency in FDA’s handling of the program and questioned its legal underpinnings, noting that Congress did not sign off on the plan.

Under the Commissioner’s National Priority Voucher program, drugmakers are promised expedited reviews of one to two months for new medicines that support “ national interests.” It’s at the center of FDA Commissioner Marty Makary’s stated goal of “cutting red tape” at the agency.

But Auchincloss says details about the program have been “shrouded in secrecy,” in part because the FDA has not responded 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,” states Auchincloss, who is a member of a House subcommittee on health.

The new scrutiny came on the same day that the FDA held an employee town hall on the program, according to three agency staffers who spoke to The Associated Press on condition of anonymity to discuss confidential agency matters. Much of the debate surrounding the program involves concerns that drug decision-making is being taken away from agency scientists.

But FDA leaders used Tuesday’s event to stress that final approval decisions continue to be made by drug center staffers, not political appointees.

“The approval decision remains with the relevant product center, using the center’s normal processes,” stated a slide presented at the meeting and shared with the AP.

In his letter, Auchincloss asserts that the FDA has failed to publish or release financial disclosure forms for eight senior FDA officials who vote on which drugs should receive priority vouchers. Membership of group, which was first reported by Stat News, is mostly comprised of officials closely aligned with Health Secretary Robert F. Kennedy Jr., including Deputy FDA Commissioner Dr. Sara Brenner, Dr. Vinay Prasad, who oversees vaccines, and Dr. Tracy Beth Hoeg, FDA’s drug center director.

The forms, which are collected annually by the Office of Government Ethics, list investments, outside income and other financial details for senior government officials and their spouses. Such disclosures are considered critical to avoiding potential conflicts of interest at the FDA, where staffers are often involved in regulating multibillion-dollar, publicly traded companies.

A Department of Health and Human Services spokesperson didn’t immediately respond to AP’s questions about the letter.

Elsewhere in his letter, Auchincloss questions whether the FDA had the legal authority to establish the voucher program without action from Congress, which typically legislates such programs into law. His letter states that the FDA’s legal office “was not consulted nor provided findings to support the agency’s claim,” that it could independently establish the program.

Several senior FDA staffers have declined to sign off on drug approvals going through the program due to legal concerns, as previously reported by the AP.

Auchincloss also notes that FDA officials did not respond to two letters he sent last year requesting information. In the new letter, the lawmaker instructs the agency to “affirm or refute,” his findings.

In November, Sen. Bernie Sanders of Vermont and Rep. Frank Pallone of New Jersey sent a letter seeking answers to 15 questions about the FDA’s voucher program. Pallone is the top Democrat on the House Energy and Commerce Committee, which oversees health agencies.

The agency did not respond to the letter, according to a committee staffer.

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