FDA would up PDUFA for DTC reviewsThe 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.
This past fall, the agency's Division of Drug Marketing, Advertising and Communication added a second DTC review group to meet soaring demand, bringing the agency's total review staff to eight. DDMAC also maintains four review groups for professional advertising.
Of the rise in user fees under the existing program, the largest chunk—$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. Other new fees would go toward expanding guidance, improving the agency's IT infrastructure, salary and benefit increases, rent and $20 million to cover “significant increases in FDA's drug review workload.”
PhRMA CEO Billy Tauzin praised the agency's PDUFA proposal, saying, “The FDA would have more resources to develop comments for companies before their ads are broadcast, which would help to ensure the advertising's accuracy, balance and compliance with all regulatory requirements.”
PDUFA IV—the fourth reauthorization of the program—must pass through Congress by October.