New White House policy could throttle FDA guidance-writing

How a new OMB policy could cripple FDA’s ability to produce guidance documents

A new Trump administration policy could slow the release of FDA guidance documents to a crawl, reducing transparency that product developers, patients and investors value.

The policy is spelled out in an April 11 memo from Russell Vought, acting director of the Office of Management and Budget (OMB), to the heads of executive departments and agencies. It requires federal agencies, including FDA, to conduct extensive cost-benefit analyses of guidances and to submit guidance documents to OMB for clearance prior to their release.

FDA has not previously been required to analyze the economic impacts of or receive OMB clearance for guidance documents.

The agency does not have enough economists to conduct analyses of the hundreds of documents it produces every year that a literal reading of the memo could require. If it

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