Congress Passes Long Awaited PDUFA Renewal Act
The U.S. House and Senate passed the long awaited FDA Revitalization Act, a five-year renewal of the Prescription Drug User Fee Act of 1992 (PDUFA). PDUFA allows the FDA to collect fees from drug and device companies applying for regulatory approval. That law was set to expire on Sept. 30.
The new bill calls for an increase in those submission fees to bolster FDA’s drug safety review and monitoring activities. Under the bill, pharmaceutical developers would pay nearly $400 million and medical device makers $48 million in fees next year, a 25% increase.
However, the bill would go much further than its predecessor. The proposed law will grant the FDA much more oversight on treatments already approved and give teeth to the agency in enforcing rules that have been ill-defined the past.
The bill would enhance the government’s clinical trial registry (clinicaltrials.gov) by making studies posted there conform to the international standards developed by the World Health Organization. Written into the bill are regulations that require drug developers to publish all clinical trial results used to obtain a drug’s approval, including any trial results used by the review committee, which reviewed the product, and any trial conducted after the product has been approved.
The law would also give the FDA the ability to impose fines on companies that do not conduct any additional studies that the agency mandated upon granting an approval. Historically, these post-approval studies were not tracked. The bill also calls for a generic drug database, a litigation clauses and orphan drug provisions.
A link to the bill can be found here.