House lawmaker raises new concerns about FDA’s drug voucher program

Summary

Rep. Jake Auchincloss, a Massachusetts Democrat, sent a letter to the Food and Drug Administration raising fresh concerns about the agency’s “National Priority Voucher” program, which is intended to speed up drug reviews for certain medicines. Auchincloss said he wants more transparency about how the program works and whether senior FDA officials involved in voucher-related decisions are complying with federal ethics requirements.

Auchincloss’s concerns centered on what he described as limited public information about the voucher program and the legal basis for how the FDA is operating it. In the letter, he argued that Congress did not sign off on the plan and said details about the “voucher” program have been “shrouded in secrecy,” in part because the FDA has not responded to multiple congressional inquiries.

The voucher program, under the FDA Commissioner’s National Priority Voucher approach, is designed to offer expedited review time frames of one to two months for certain new medicines that support “national interests.” The program has been promoted as part of a broader effort by FDA Commissioner Marty Makary to “cut red tape” at the agency, according to the Associated Press report.

Auchincloss also raised questions about whether the FDA acted within its authority when it established the voucher program. His letter said the FDA’s legal office “was not consulted nor provided findings to support the agency’s claim” that the agency could independently establish the program without additional Congressional action.

The scrutiny also focused on the role of senior FDA officials associated with the voucher decisions. Auchincloss said the FDA has not published or released financial disclosure forms for eight senior FDA officials who vote on which drugs should receive priority vouchers, a group that was first reported by Stat News and is described as being closely aligned with Health Secretary Robert F. Kennedy Jr.

According to the Associated Press report, those disclosures are collected annually by the Office of Government Ethics and include information such as investments and outside income, which lawmakers say are important for identifying potential conflicts of interest for senior government officials and their spouses. The report also said some senior FDA staffers have declined to sign off on approvals for drugs going through the program due to legal concerns.

The new letter arrived as the FDA held an employee town hall on the voucher program. Three agency staffers who spoke to the Associated Press on condition of anonymity said much of the debate among staff involves concerns that drug decision-making is being taken away from agency scientists, but FDA leaders used the event to emphasize that final approval decisions continue to be made by drug center staff rather than political appointees.

A slide presented at the meeting and shared with the AP said, “The approval decision remains with the relevant product center, using the center’s normal processes,” reinforcing the message that the voucher-related pathway does not change where the approval decision is formally made. In his letter, Auchincloss also pointed to what he said were unanswered requests for information sent last year, and he instructed the agency to “affirm or refute” his findings.

Auchincloss’s letter adds to earlier congressional pressure on the voucher program. In November, Sen. Bernie Sanders of Vermont and Rep. Frank Pallone of New Jersey sent a letter seeking answers to 15 questions, and Pallone is the top Democrat on the House Energy and Commerce Committee, which oversees health agencies; the AP report said the agency did not respond to the November letter, according to a committee staffer.