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# FDA Reevaluating Makary’s Journal Articles, Podium Policies: DeGette
- URL: https://www.fdaweb.com/fda-reevaluating-makarys-journal-articles-podium-policies-degette/
- Published: 2026-07-16T12:00:00.000Z
- Updated: 2026-09-14T13:43:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161469

Rep. **Diana DeGette** (D-CO) took FDA to task recently, winning assurances from the agency that several policy announcements issued during former commissioner **Marty Makary**'s tenure — including articles published in medical journals and media interviews — are not intended to be recognized as official agency guidance. During a 4/16 House Energy and Commerce Health Subcommittee hearing on maintaining U.S. leadership in drug development ([see earlier story](https://www.fdaweb.com/hearing-highlights-concerns-over-biomedical-innovation-growing-in-china/)), DeGette disclosed that she had sent FDA a letter in February questioning whether several policy announcements issued while Makary was in office constituted official agency guidance.

According to DeGette, FDA responded last week that the communications in question “were not in fact guidance and did not communicate FDA policy.” That response was penned by acting commissioner **Kyle Diamantas**, according to a letter obtained by the Regulatory Affairs Professionals Society. Diamantas reportedly told DeGette the agency is not using those publications as regulatory guidance and that they were intended to provide scientific analysis rather than establish binding FDA policy. He also indicated that FDA is evaluating whether additional formal guidance is needed for programs announced during the previous leadership.

According to Diamantas’ letter, a 2025 *JAMA* article authored by Makary and former CBER director **Vinay Prasad** outlining expectations for CAR T-cell therapies "was not intended to communicate FDA policy" and is not being relied upon in regulatory decision-making. Likewise, he said a *New England Journal of Medicine* article describing a proposed approval pathway for ultra-rare diseases and an FAQ announcing the National Priority Voucher program should not be interpreted as formal FDA policy. The agency is continuing to evaluate whether additional guidance is warranted for the voucher program, he said.

During her remarks at the hearing, DeGette contrasted what she characterized as the disruption under former Makary with what she said are early signs of a return to more traditional regulatory practices under Diamantas. “I've never seen a more precarious time for U.S. leadership around the world in biomedical research," DeGette said, arguing that FDA's ability to oversee clinical trials and ensure scientific integrity has been weakened over the past year and a half.

The Colorado Democrat said the FDA lost about 3,500 employees following workforce reductions led by the Department of Government Efficiency (DOGE), headed then by **Elon Musk**, leaving the agency with diminished expertise and low employee morale. She also accused political appointees of making decisions that should have been left to career scientists.

"The agency is now in the process of hiring thousands of staff to fill critical gaps," she said, although she acknowledged recruitment has been hampered by reputational damage from the earlier workforce reductions.

She also praised Diamantas, saying he has demonstrated a willingness to empower career scientists and restore confidence in the agency's scientific review process.

DeGette said FDA's return to greater transparency and adherence to established guidance procedures will be critical as Congress prepares to reauthorize the agency's user fee programs next year.