ANN ARBOR, Mich. For the past ten years, drug companies have paid the U.S. Food and Drug Administration fees to review each new drug they want approved. But a new study shows that this program hasn't made the approval process any quicker -- its main goal -- than increased federal funding for the FDA was already doing before the industry fee program began.

The study, by a team from the University of Michigan and Harvard University, also counters critics' claims that the fee-based system might cause the FDA to give special treatment to larger, more powerful drug companies. The researchers found no evidence that those firms got faster approvals for their products. The results will be published online Dec. 17 by the journal Health Affairs.

"The bottom line is that the more staff the FDA has reviewing drug applications, the faster the approval process will be," says senior author A. Mark Fendrick, M.D., of the U-M Medical School and School of Public Health. "If you want more rapid assessment of new drugs, hire more people. And if you're still concerned about external influence or potential conflicts, fund them through additional mechanisms."

Fendrick and his colleagues compiled the new findings using a detailed analysis of 843 new drugs submitted for FDA approval between 1977 and 2000, including 320 drugs that were rejected. They looked at approval times for the drugs submitted in each year, and concurrent levels of FDA drug-review staffing. The analysis also included scrutiny of each drug's disease indications, and each drug company's sales totals, number of recent FDA submissions and lobbying budget.

The results enabled the researchers to see trends both before and after the passage of the Prescription Drug User Fee Act (PDUFA) in 1992. PDUFA set fees that companies pay to the FDA, to offset the cost of hiring additional reviewing staff. In the 10 years since PDUFA took effect, companies have paid about $1 billion in fees.

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Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
17-Dec-2003

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