Reduction in US FDA Guidance production

Date

May 15, 2025

Category

US Regulations

Description

The production of FDA Guidance has slowed significantly since President Trump took office, with many product-specific guidance (PSG) documents, which provide bioequivalence and other information for generic drug development, not being released as scheduled. The development of new guidance to help speed generic drugs to market has almost stopped since layoffs at FDA decimated its policy staff, with just 7 guidance documents across all centers being issued since President Trump’s inauguration. The generic drug industry is very concerned as it uses the FDA guidance to set development priorities.

The FDA has published more than 2,200 PSGs over the years and, historically, has regularly updated them. As of 14 May, no new or updated PSGs have been published since November 2024 despite the FDA website (see Upcoming Product-Specific Guidances for Generic Drug Product Development | FDA ) listing 36 new PSGs scheduled to be published in February and another 10 in May.

On 13 May 2025 the U.S. Department of Health and Human Services (HHS) and the FDA announced the launch of a public Request for Information (RFI), with a 60-day response period, to identify and eliminate outdated or unnecessary regulations; see HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers. The initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency, in alignment with President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation.” Under the directive, HHS Secretary Robert F. Kennedy, Jr. has committed the HHS to a "10-to-1" deregulatory policy: for every new regulation proposed, at least ten existing regulatory actions will be rescinded.