Rep. Auchincloss Seeks FDA Whistleblowers
Representative Jake Auchincloss (D-MA) is urging FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers. “FDA Commissioner Marty Makary’s incompetence and poor stewardship are undermining the Food and Drug Administration,” Achincloss says in a video posted on X. “Multiple former senior FDA officials have confided to me that the world’s gold standard biomedical regulator has hemorrhaged 20 years of credibility in just the past year. If you are an FDA employee who was illegally fired, intimidated, silenced, or if you have knowledge of malfeasance, corruption, or abuses of power at the FDA under commissioner Makary, I want to hear from you. Your disclosure can have a real impact. Congress relies on whistleblowers to shine light on misconduct and to strengthen our constitutional oversight of the federal government.”
Recently, Auchincloss has been critical of FDA’s new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program undermines scientific standards and the agency’s credibility. In an interview with U.S. News & World Report, Auchincloss, a member of the House health subcommittee, described FDA’s Commissioner’s National Priority Voucher program as a “short-circuiting” of the traditional drug review process and called on Makary to step down.
Auchincloss argued that the program enables the commissioner to grant favored companies a higher probability of receiving approval, a move he claims is intertwined with drug pricing negotiations and White House priorities. “The FDA has to evaluate drugs based on safety and efficacy — not on any consideration of price,” he said, asserting that tying regulatory decisions to pricing discussions would be illegal.
He has sent three letters to Makary outlining his concerns, citing whistleblower accounts, industry feedback and public reporting as reinforcing his view that the program constitutes “a political end run around career scientists.”
The Massachusetts lawmaker warned that patients and physicians rely on the FDA’s reputation as the global “gold standard” regulator. Introducing political considerations into the review process, he said, risks weakening that trust. “When it’s political appointees, then patients have less confidence,” Auchincloss said. “The White House is looking for a short-term win rather than long-term safety and efficacy.”
He suggested that drugs approved under the program could face heightened scrutiny from hospitals and formulary committees, and said the industry itself should not have confidence in the program. “I think it’s a poisoned chalice,” he said.
Auchincloss also criticized House Republicans for not holding oversight hearings on the voucher program. He said the top priority should be compelling Makary to testify before the health subcommittee. “Makary needs to sit in front of the House health subcommittee and answer for his terrible stewardship,” Auchincloss said, adding that if Democrats regain control of the chamber, oversight would intensify.