FDA, industry agree on PDUFA deal to speed NME reviews

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The FDA and the biopharma industry have agreed in principle on a revamp of the Prescription Drug User Fee Act (PDUFA), by which pharmas provide nearly two-thirds of what the agency spends on drug reviews.

The agency, which is still wrangling with the generic drug and device industries over user fee agreements, published a draft, dubbed “PDUFA Reauthorization Performance Goals for 2013 through 2017,” which PhRMA described in a statement as “the result of lengthy technical negotiations between the biopharmaceutical industry and the FDA.”

The agency's outline includes measures aimed at speeding reviews of New Molecular Entities, in part by facilitating more and better dialogue between companies with NMEs up for review and the agency. That had emerged as a priority during the drafting of industry's PDUFA wish list.

Said PhRMA: “FDA's robust drug safety system would also be strengthened through provisions in the agreement hat include greater standardization of and earlier consideration of risk evaluation and mitigation strategies in the review process, support for the use of Sentinel as a tool for assessing post-market safety issues, methods for maximizing existing FDA tools for adverse event detection, and adoption of standardized approaches for electronic information.”

Biotech trade group BIO also gave the agreement its blessing, saying “Unpredictability in the review process, suboptimal communication with sponsors and decreased FDA performance not only hinders patient access to new treatments but also negatively impacts the ability of biotechnology companies to raise funding to support clinical development and ongoing innovation.”

The agreement must be voted on by Congress and signed by the President before September 2012, when the current PDUFA expires, or the approvals process would grind to a near halt.
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