FDA Makary voucher drug reviews.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times. The initiative by FDA Commissioner Marty Makary promises ultra-fast reviews for drugs that align with “U.S. national priorities.” It’s at the center of Makary’s stated goal to “cut red tape” and “challenge assumptions” at the agency tasked with assuring the safety of food, medicines, medical devices and other consumer goods. But FDA staffers tell The Associated Press the push for faster approvals is contributing to a climate of anxiety, fear and confusion within the agency’s drug center.

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Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks during a press briefing at the White House, Wednesday, Jan. 7, 2026, in Washington. (AP Photo/Jacquelyn Martin)

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that’s been rocked by recent layoffs and resignations. Agency staffers and outside experts worry the FDA commissioner’s voucher program runs afoul of legal, ethical and scientific standards used to review new medicines. FDA staffers tell The Associated Press the effort is taking decisions away from career scientists and placing them in the hands of political appointees. The program awards vouchers to drugs favored by President Donald Trump’s administration, promising reviews in as little as one month, not six to 10 months. Health and Human Services says the voucher program prioritizes “gold standard scientific review.”

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