By MATTHEW PERRONE
WASHINGTON (AP) — A Democratic lawmaker raised new concerns about a Food and Drug Administration (FDA) 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, Representative Jake Auchincloss of Massachusetts took issue with the lack of transparency in the FDA’s handling of the program and questioned its legal basis, noting that Congress has not signed off on the plan.
Under the Commissioner’s National Priority Voucher program, drugmakers are promised expedited reviews of one to two months for new drugs that support the “national interest.” This is at the heart of FDA Commissioner Marty Makary’s stated goal of “cutting red tape” at the agency.
But Auchincloss said details about the program are “shrouded in secrecy,” in part because the FDA has not responded to multiple congressional questions.
“The public must have transparency regarding the ‘voucher’ program, under which drug approvals have been conducted almost entirely and in an unprecedented manner by the FDA’s political leadership,” said Auchincloss, who is a member of the House health subcommittee.
The new oversight came the same day that the FDA held an employee meeting regarding the program, according to three agency staffers who spoke to The Associated Press on condition of anonymity to discuss a confidential agency matter. Much of the debate surrounding the program involves concerns that decision-making about medicines will no longer be in the hands of scientists.
But FDA leaders used Tuesday’s event to emphasize that final approval decisions continue to be made by drug center staff, not political appointees.
“Approval decisions remain in the hands of the relevant product center, using that center’s normal processes,” said a slide presented at the meeting and shared with the AP.
In his letter, Auchincloss asserted that the FDA had failed to issue or release financial disclosure forms for the eight senior FDA officials who voted on which drugs should receive priority vouchers. The group’s membership, first reported by Stat News, consists largely of officials with close ties to Health Secretary Robert F. Kennedy Jr., including FDA Deputy Commissioner Dr. Sara Brenner, Dr. Vinay Prasad, who is overseeing the vaccine, and Dr. Tracy Beth Hoeg, director of the FDA’s drug center.
The form, compiled annually by the Office of Government Ethics, lists investments, outside income and other financial details for senior government officials and their spouses. Such disclosures are considered important to avoid potential conflicts of interest at the FDA, where staff are often involved in the regulation of billion-dollar public companies.
A spokesman for the Department of Health and Human Services did not immediately respond to AP questions about the letter.
Elsewhere in his letter, Auchincloss questions whether the FDA has the legal authority to establish a voucher program without action from Congress, which typically enacts such programs into law. His letter states that the FDA’s legal office “was not consulted or provided findings to support the agency’s claims,” that the agency could have created the program independently.
Some senior FDA staff refused to sign off on approval of the drug to undergo the program due to legal concerns, as previously reported by the AP.
Auchincloss also noted that FDA officials did not respond to two letters he sent last year requesting information. In the new letter, lawmakers instructed the agency to “affirm or deny,” its 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 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 committee staff.
The Associated Press Health and Science Department receives support from the Department of Science Education at the Howard Hughes Medical Institute and the Robert Wood Johnson Foundation. AP is solely responsible for all content.
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