FDA Chief Says He Won’t Reorganize Agency After Mass Layoffs (1)

The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, and other departments, an HHS spokesperson confirmed with Bloomberg Law.

The Food and Drug Administration’s plan was first reported Tuesday by MedPageToday in an interview with Commissioner Marty Makary. The former Johns Hopkins surgeon said “there will not be a reorganization,” when asked about restructuring the agency’s centers and divisions.

Makary in the interview said he rejected a reorganization proposal that was offered by some staff, and the agency now only plans to consolidate travel offices and information technology.

Makary’s comments come after the US Department of Health and Human Services executed massive layoffs April 1 across federal health agencies, aiming to drastically reduce the size of its workforce. The cuts targeted 3,500 employees at the FDA and broadly hit staff working in program management, human resources, technology, policy, communications, and other administrative areas.

Makary said in the interview that the FDA’s staff has increased over the years, which resulted in an “increased regulatory creep.”

Employees left at the agency have expressed concerns about completing drug, medical device, and food reviews after the FDA culled administrative and support staff that would have helped them carry out their responsibilities.

Makary, however, said that center leaders are confident they will reach targets under the Prescription Drug User Fee Act (PDUFA). That act allows the FDA to collect sizable fees from industry so that the agency can complete reviews in a timely manner.

Stealth BioTherapeutics Inc., a biotech company, said Tuesday that the FDA communicated that it would not meet the April 29 PDUFA date for its New Drug Application for elamipretide, a drug created to treat Barth syndrome.

The FDA has delayed this PDUFA date before, according to Stealth.

A spokesperson for HHS said the FDA can’t comment on any pending application to preserve the integrity of the review process.

“Any delays in drug approvals are the result of the FDA’s rigorous review process, which is designed to ensure that all medications are safe and effective for the American people. These delays are not connected to the recent reorganization,” the spokesperson said in a statement.