The Food and Drug Administration recently proposed recommendations to Congress that would broaden and upgrade the agency’s drug safety plan, increase resources for television advertising review and improve drug development processes.

The recommendations are part of the reauthorization process for the Prescription Drug Use Fee Act, which requires drug companies to contribute money to expedite the FDA’s human drug review programs. The PDFUA was passed by Congress in 1992 and has enabled the FDA to reduce its review times dramatically, while increasing scientific consultations, clarifying drug development issues, and increasing oversight of postmarket drug safety.

The FDA proposed an $87.4 million user-fee increase that would pay for the program enhancements; the largest portion of the money—$37.9 million—would boost postmarket drug safety efforts. In addition, the proposal calls for the creation of a separate user fee program that would collect new fees from companies that seek FDA advisory reviews of their direct-to-consumer television advertisements.

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