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Wednesday, December 17, 2003

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Staffing Levels, Not User Fees, Responsible For Decline
In Prescription Drug Approval Times, Health Affairs Study Says

Analysis Shows No Reduction In Approval Times
Had FDA Not Expanded Drug Evaluation Center


BETHESDA, MD—Prescription drug review times have declined by 3.3 months for every 100 staff members added to the Food and Drug Administration’s drug review division since 1977, but the effects have been less pronounced since the federal government began charging user fees to applicants in 1993, according to a new study published on the Health Affairs Web site, www.healthaffairs.org.

The study authored by a group of scholars from the University of Michigan says the reduction in approval times is more related to the resources appropriated for the FDA than it is to the source of funding.

Before 1993, when the Prescription Drug User Fee Act (PDUFA) authorized the FDA to begin collecting levies from pharmaceutical manufacturers and use them to fund drug review activities, adding 100 staff members to the FDA sped approval times by an average of 6.6 months, say the authors, led by Harvard University government professor Daniel Carpenter, who did the work while he was at the University of Michigan.

Their statistical analysis indicates that had staffing levels remained constant following enactment of PDUFA, there would have been no reduction in approval times.

“Our results do not uphold the industry’s claim that the recent decline in approval times is entirely attributable to user fees,” Carpenter says. “While PDUFA may have further reduced review times, it did so because it increased staff resources at the FDA.

“We stress that a substantial staff-related decline occurred in the five years before PDUFA’s passage,” Carpenter says. “We strongly believe that nearly all of the decrease in approval times would have been achieved had the FDA been appropriated these funds directly, instead of relying on user fees.”

The authors also found:
• Larger pharmaceutical companies did not experience faster reviews
• Firms that spent more on lobbying did not experience faster reviews

Carpenter’s coauthors were Michael Chernew, an associate economics professor in the University of Michigan School of Public Health’s Department of Health Management and Policy; Dean Smith, a health policy professor in the same department; and Mark Fendrick, a professor of general medicine in the University of Michigan medical school’s internal medicine department. Carpenter’s research is supported by the National Science Foundation and the Robert Wood Johnson Foundation Scholars in Health Policy Program.

To view the article, click http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w3.618.

Health Affairs, published by Project HOPE, is a bimonthly multidisciplinary journal devoted to publishing the leading edge in health policy thought and research.



©2003 Project HOPE–The People-to-People Health Foundation, Inc.