FDA commissioner's drug review plan sparks alarm across the agency

"The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical, and scientific standards long used to vet the safety and effectiveness of new medicines. Marty Makary's program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts, and leadership upheavals, according to seven current or recently departed staffers."

"At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioner's National Priority Voucher program, which promises approval in as little as one month for medicines that support "U.S. national interests." Traditionally, approval decisions have nearly always been handled by FDA review scientists and their immediate supervisors, not the agency's political appointees and senior leaders."

"Outside experts point out that FDA drug reviews-which range from six to 10 months-are already the fastest in the world. "The concept of doing a review in one to two months just does not have scientific precedent," said Dr. Aaron Kesselheim, a professor at Harvard Medical School. "FDA cannot do the same detailed review that it does of a regular application in one to two months, and it doesn't have the resources to do it.""

Marty Makary's program aims to drastically shorten FDA drug review timelines, promising approval in as little as one month for medicines deemed to support U.S. national interests. The initiative is generating alarm, legal and ethical concerns, and confusion among staff already affected by layoffs, buyouts, and leadership upheavals. Questions persist about which officials have authority to sign off on expedited approvals and whether political appointees will encroach on scientific review processes traditionally handled by FDA scientists and supervisors. Reviewers report limited information on the program and pressure to skip regulatory steps for an anticipated anti-obesity pill. Experts caution one- to two-month reviews lack scientific precedent and the necessary resources to perform detailed evaluations.

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