User Fees, Drug Safety - Pharmaceutical Technology

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User Fees, Drug Safety
Top Priorities for FDA


Pharmaceutical Technology



Jill Wechsler
The US Food and Drug Administration is setting the stage for a broad debate over how much the agency should rely on industry payments for support, and how much control FDA should have over how user-fee revenues are spent. FDA officials would like to allot more fee revenues to drug-safety surveillance, an area that continues to draw attention from Congress as well as the media. Another challenge for the agency is to encourage and regulate new vaccines and drugs to protect against pandemic disease and bioterrorism. All these initiatives will stress FDA's tight budget for the coming year, which relies increasingly on user fees to support its expanding responsibilities.

Debate begins

FDA opened the debate about reauthorizing the Prescription Drug User Fee Act (PDUFA 4) at a public meeting this past November. FDA Acting Commissioner Andrew von Eschenbach termed PDUFA reauthorization critical to FDA's ability to bring new medical discoveries to patients. FDA Deputy Director Janet Woodcock described how user fees support a broad range of FDA activities from early discovery through postmarket surveillance. The added resources from user fees over the past decade have improved the new drug application (NDA) approval process, noted Steven Galson, director of the Center for Drug Evaluation and Research (CDER). Most NDAs need only one review cycle to gain approval, he pointed out, and the scientific expertise of CDER's staff has improved noticeably. An FDA white paper explains the agency's case for more appropriated funding and user fee collection to support its more-complex and costly drug review process (white paper available at http://www.fda.gov/oc/pdufa).

Similar discussions have begun involving reauthorization of user fees for medical device manufacturers, which also expire in 2007. Officials at FDA's Center for Devices and Radiological Health want to use some fees collected under the Medical Device User Fee and Modernization Act of 2002 for postmarket surveillance, a proposal gaining momentum following recent safety crises involving pacemakers and defibrillators.

Although some consumer advocates and their Congressional allies criticize user fees for extending industry control over the drug approval process, FDA officials, pharmaceutical manufacturers, and patient-disease groups applaud the program's success in ending drug lag and speeding new therapies to market. At the same time, FDA officials seek more flexibility that will allow it to use more of the $250 million user-fee revenues to expand postapproval drug safety surveillance, boost scrutiny of direct-to-consumer advertising, and support collaborative research activities under its Critical Path initiative.

FDA cites a growing workload to justify fee revisions. Although NDAs and biologics license applications (BLAs) remain fairly flat, manufacturing and efficacy supplements continue to rise, and chemistry and manufacturing controls supplements have doubled from 1247 in 1993 to 2481 in 2004. In addition, FDA struggled this past year to prepare for more than 2000 industry-requested meetings and to assess nearly 350 special research protocols under tight deadlines, including requests for FDA to evaluate new carcinogenicity and stability-testing methods.

No Christmas trees

Manufacturers basically want to renew PDUFA but hold the line on fee increases and the use of fee revenues for activities unrelated to drug development and market approval. It now costs sponsors nearly $800,000 to file an NDA or BLA, an amount spurring proposals for more waivers and reduced fees for small companies and orphan drug developers.

Industry's broader goal is to prevent a PDUFA reauthorization bill from becoming a "Christmas tree" loaded with legislation peripheral to the drug approval process. Measures to spur development of follow-on biologics, to establish new drug safety oversight arrangements, to mandate completion of postapproval studies, and to boost oversight of direct- to-consumer advertising are just some of the popular proposals circulating on Capitol Hill.

Manufacturers have no problem, though, with linking PDUFA legislation to a bill reauthorizing incentives for studying drugs in pediatric populations, which also is up for renewal in 2007. The six-month patent extensions on drugs that add pediatric information to labels have been a boon for pharmaceutical companies, while also generating important prescribing information for physicians and patients. Generics makers object that the patent extensions only boost drug costs for everyone. But, doctors applaud the new pediatric formulations and useful prescribing information generated by the program.


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