FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes

 

Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.

The FDA is seeking new powers to enforce requirements related to postapproval manufacturing changes as part of the Trump administration’s fiscal year 2027 budget proposal.

Through the funding request, released April 3, the agency proposed legislative changes intended to help it meet its goals for 2027. One proposal covers the validation and authorization of postapproval manufacturing updates. These include major changes such as the use of a different facility or active pharmaceutical ingredient (API) supplier. Such changes can adversely affect the safety or effectiveness of the finished product.

To mitigate that risk, the FDA has proposed revising drug and biologics laws to clarify the agency’s ability to enforce manufacturing change requirements. The legislative changes are intended to ensure that people are not exposed to medicines until postapproval changes have been appropriately validated.

Legislation published in 1997 requires manufacturers to receive approval for major changes, which the FDA will review before they apply to products delivered to patients. However, the agency has identified a need to revise various sections of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act to clarify its powers.

The FDA has also requested “express authority to require actions to address residual quality risks in the postapproval period.” Using its authority, the agency could make companies provide information on ongoing quality via postapproval updates.

The FDA said the powers would support its ability to identify and act against adulterated products.

The agency also wants lawmakers to confirm and expand its ability to disclose and use certain information related to drug impurities when it deems these actions to be in the interest of public health. The FDA said early identification of impurities and disclosure of acceptable intake limits would support timely corrective actions, such as changes to manufacturing processes and product reformulations.

Other proposals include a request for powers to withdraw products from the market if companies fail to report how much API they source from each supplier listed in their approval submissions. The FDA said the current situation hinders its visibility into the supply chain.

The proposals will facilitate the FDA’s transition “from a reactionary system to a proactive system,” Commissioner Marty Makary wrote in his opening letter for the 2027 budget document.

Finally, the budget proposal includes a request for $9 million and 19 full-time employees to accelerate advanced manufacturing. The money will fund initiatives including PreCheck, a new FDA program intended to help companies build manufacturing facilities in the U.S.

https://www.biospace.com/fda/fda-seeks-expanded-authority-to-regulate-postapproval-manufacturing-changes