Article Summary:
The U.S. Food and Drug Administration (FDA) has proposed several changes to the Generic Drug User Fee Amendments (GDUFA) program as part of the renewal process for fiscal years 2028-2032. One key proposal is to waive annual facility fees for the first three years for companies that establish domestic manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs).
However, the pharmaceutical industry has opposed this proposal, arguing that there are more effective ways to enhance domestic manufacturing capacity, such as expanding production at existing U.S. facilities or retrofitting unused ones. Industry representatives claim the waiver would unfairly subsidize new competitors at the expense of established U.S. manufacturers.
The FDA has also proposed raising the foreign facility fee from $15,000 to $25,000 to account for inflation and facilitate more unannounced inspections of overseas facilities. The industry opposes this increase, fearing it may lead companies to exit the U.S. generic drug market.
Additionally, the FDA has proposed prioritizing ANDA reviews for firms that conduct pivotal bioequivalence testing in the U.S., have a waiver from bioequivalence testing, or manufacture finished dosage forms domestically. The industry agrees this could encourage domestic manufacturing and testing but is unsure if the FDA can grant priority review to companies meeting only a subset of the criteria.
Finally, the FDA suggests extending ANDA goal dates by 180 days if there are data fidelity or integrity issues related to bioequivalence or bioanalytical data. The industry supports this proposal but questions how it will address the root causes of such data problems.
Overall, the FDA’s proposals aim to enhance domestic pharmaceutical manufacturing and reduce reliance on foreign production, though the industry has raised concerns about the effectiveness and potential unintended consequences