FDA agrees to deal that speeds reviewsThe Food and Drug Administration and the biopharma industry have agreed in principle on a revamp of the Prescription Drug User Fee Act, by which drug firms 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 the Pharmaceutical Research and Manufacturers of America described as “the result of lengthy technical negotiations between the biopharmaceutical industry and the FDA.”
The act was first enacted in 1992.The agency's new 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.
Biotech trade group BIO gave the agreement its blessing, expressing hopes of improved communication and less unpredictability for stakeholders.
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 could grind to a near halt.