The Food and Drug Administration is seeking new legislative powers to enforce requirements related to postapproval manufacturing changes, according to an April 7 announcement as part of the Trump administration’s fiscal year 2027 budget proposal.
The agency’s request aims to ensure that medicines remain safe and effective after major updates in their production process. These proposed legislative changes are intended to clarify the FDA's ability to validate and authorize significant manufacturing updates, such as switching facilities or active pharmaceutical ingredient suppliers, which can impact drug safety or effectiveness.
The FDA has called for revisions to drug and biologics laws so it can better enforce these requirements. The agency said these steps would help prevent patients from being exposed to medicines until all postapproval changes have been properly validated. Existing legislation from 1997 requires manufacturers to get approval for major production changes, but the FDA says more clarity is needed in federal law about its enforcement powers.
Additionally, the FDA has asked for express authority to require companies address quality risks during the postapproval period by providing ongoing information through regular updates. The agency said this would improve its ability to identify and act against adulterated products.
Another part of the proposal seeks confirmation and expansion of the FDA's power regarding information on drug impurities when it serves public health interests. Early identification of impurities could lead to faster corrective actions like reformulating products or changing manufacturing processes. The agency also wants stronger authority over supply chain transparency, including withdrawing products if companies fail to report how much active ingredient they obtain from each approved supplier.
FDA Commissioner Marty Makary wrote that these proposals will help move "from a reactionary system to a proactive system." The budget request also includes $9 million and funding for 19 full-time employees dedicated toward accelerating advanced manufacturing initiatives such as PreCheck, a program designed to support building new U.S.-based facilities.
