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PDUFA Likely to Stay, and Fee Hike Will go to Post-Market Safety

NEW YORK, March 7 - Biotech companies, including genomics-firms-cum-drug-discoverers, will get to keep the Prescription Drug User Fee Act, but it'll cost them a bit more than they're used to.

After seven months of back-room negotiations, the US Food and Drug Administration and the pharmaceutical and biotechnology industries have come to a provisional agreement on a new version of the popular act.


By the proposed deal, the FDA will be able to hike drug fees by about 40 percent by 2003. This means that total collections under PDUFA would climb to about $260 million in five years from roughly $160 million this year.


In return, the FDA will use the extra cash to improve and accelerate safety reviews of newly approved drugs, doubling its drug-safety staff within five years.


PDUFA, originally enacted in 1992, uses fees collected from the pharmaceutical industry to underwrite FDA expenses from the drug-approval process. The act is set to expire this fall.


The president's budget proposal, released in early February, initially projected a 60 percent hike in PDUFA fees. The whopping increase caught biotech and pharma industry leaders by surprise. "The current budget proposal reflects a basic misunderstanding of the economics of the biotechnology industry," said Biotechnology Industry Organization president Carl Feldbaum in a statement at the time.


Since then, government and industry reps have been hammering out a compromise that would both provide the FDA with more money and address the needs of the biotech and pharma industries.


On Wednesday, the US House of Representatives Energy and Commerce Committee's health subcommittee heard testimony from agency and industry representatives on the proposed changes to the act. Elan Pharmaceuticals Executive Vice President Mary Pendergast, on behalf of BIO, outlined some of the other FDA changes that the lobbying group has negotiated as part of this compromise:


--The industry wants to be able to separately track review times for the FDA's Center for Drug Evaluation and Research, which governs drug approvals, and the Center for Biologics Evaluation and Research, which oversees many new biotech products.


--BIO also asked that the FDA improve early communications in order to shorten the number of review cycles it requires to act on a drug, device, or new technology application.


--The organization also asked the FDA to bring in outside experts to help evaluate clinical trial design for complex new technologies.


Ultimately, only Congress can decide whether to reauthorize PDUFA,  but the subcommittee is expected to use these recommendations to shape the new version of the law.

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