Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IV

Consumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines.

The groups argued that current testing capacity is insufficient to maintain confidence in the safety and efficacy of generic drugs that patients rely on.

They also urged the agency to adopt stricter metrics for post‑market safety reporting, aiming to improve transparency and monitoring of adverse events.

The request comes as the FDA prepares to implement GDUFA IV, which will shape the regulatory and financial framework for generic drug manufacturers in the coming years.