FDA wants new teeth. On April 3, the agency sent Congress legislative proposals under the Trump administration’s FY2027 budget, asking for explicit authority to enforce postapproval manufacturing change requirements.
The core ask: block drugs from reaching patients until major changes are properly validated. That covers switching facilities and swapping API suppliers. The 1997 law requires approval for major changes, but FDA says gaps in the Federal Food, Drug, and Cosmetic Act limit what it can actually enforce.
There’s a sharper ask buried deeper. FDA wants power to withdraw products from the market if companies don’t report how much API they source from each listed supplier. Not a warning letter. A market withdrawal. The agency said the current setup “hinders its visibility into the supply chain.”
If Congress agrees, the compliance stakes shift hard. What used to end in a Form 483 could now end with product off shelves. Commissioner Marty Makary framed it as moving “from a reactionary system to a proactive system” — language that tends to mean someone’s about to have a bad quarter.
The budget also requests $9 million and 19 full-time employees for advanced manufacturing, including a new PreCheck program to help companies build U.S. facilities.
Congress still has to pass it.
Sarah Chen