FDA PDUFA outline proposes 27 new staffers to review DTC ads, user fees of over $6 million projected

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The FDA says it needs 27 additional staff to review DTC TV ads and projects related user fees of $6.2 million in 2008. The agency called for a separate new user fee program to cover DTC TV ad reviews in its proposed outline for reauthorization of the Prescription Drug User Fee Act. The agency’s plan would raise user fees under the existing program by $87.4 million to $392.8 million annually in order to fund an expanded drug safety programming, increased screening of DTC ads and the agency’s Critical Path initiative. Of the rise in user fees, $29.3 million would go toward postmarket drug safety programs, allowing the agency to modernize its data analysis techniques for the detection and prevention of adverse events and hire an additional 82 employees to audit drugs already on the market for safety issues. The FDA also called for elimination of a statutory provision that says PDUFA fees can only be used to assess safety issues during the first three years after a product’s approval. An additional $4.6 million would go toward hiring 20 employees to expand guidance for reviewers and develop industry guidelines on clinical trial designs, while $4 million would go toward improving the agency’s IT infrastructure. For salaries and benefit increases to keep pace with inflation, the agency is asking for $17.7 million, along with $11.7 million to cover rent and the cost of the agency’s move to Silver Springs and $20 million to cover “significant increases in FDA’s drug review workload.” PhRMA CEO Billy Tauzin praised the agency’s PDUFA proposal. PDUFA IV, as it’s known – the fourth reauthorization of the program since its 1992 inception – must pass through Congress by October.
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