PDUFA Faces Rough Reauthorization.
Year: 2007
Type: article
Abstract: For 15 years, the U.S. Food and Drug Administration has relied on the application, product, and establishment fees required in the Prescription Drug User Fee Act (PDUFA) to help fund its drug reviews. This year, PDUFA is up for its five-year reau-thorization vote in Congress, and the fiscal 2008 version of the act — PDUFA 4 — comes with both an industry commitment to sweeten its contribution to the FDA by $87 million and the enthusiastic endorsement of FDA Commissioner An-drew von Eschenbach.
“User fees have allowed the FDA to become more modern and to build on its reputation as the world’s leading drug regulatory agency,” Eschenbach was quoted in an FDA statement.
In an ideal world, Congress would provide the FDA with all the money it needs to do all of its work, says Susan Wood, PhD, now with the Project on Scientific Knowledge and Public Policy, at George Washington University.
But the new money and high-powered testimonial aren’t enough to tamp down the intense debate revolving around the act.
PDUFA has become a lightning rod for agency critics who say that the industry’s hefty fees come at a heavy cost. drug-approval deadlines spelled out in the act are skewing the agency’s focus, they say, raising safety issues and making the relationship between regulators and the drug companies they supervise far too cozy.
“User fees may appear to save taxpayer money, but at an unacceptable cost to public health,” warns a letter from one panel of experts that includes several people who coauthord a recent Institute of Medicine report harshly criticizing the FDA’s safety record.
The simple consequence is that meeting those deadlines has sucked up more of the FDA’s resources while funding for the rest of the agency’s responsibilities has remained flat, says Susan Wood, PhD, former director of the FDA’s Office of Women’s Health and who resigned in 2005 over the agency’s lingering failure to take action on Plan B, the morning-after pill. With PDUFA focused on “premarket reviews,” she adds, “there was much less [funding] available for postmarket surveillance or safety or marketing issues.”
Others have raised concerns as well. Harvard Medical School Professor Jerry Avorn, MD, wrote in the New England Journal of Medicine that PDUFA also has made the drug industry far too influential in what should be a completely independent agency working for the health and safety of the American people.
“Colleagues at the FDA have told me of a worrisome side effect of PDUFA: the growing sense that the organization is accountable to the industry it regulates,” Avorn wrote. “One FDA scientist, who was often criticized for being too concerned about drug-risk data, was told by his supervisor to remember that the agency’s client was the pharmaceutical industry.”
Both Wood and Avorn cite research by Harvard’s Daniel Carpenter, PhD, that suggests that drugs approved right on deadline are more likely to present safety problems and require new drug warning labels.
“Everybody feels pressure to meet that [PDUFA] deadline and meet that performance goal,” says Wood. But there’s no similar deadline pressure to review safety submissions or ensure that label changes are made within a certain time period.
In an ideal world, says Wood, Congress would provide the money that the FDA needs to do all of its work. After all, PDUFA only supplies $300 to $400 million of the FDA’s budget — a drop in the bucket compared with budgets needed for defense or Medicare.
“We need to rebalance,” adds Wood. “If we must have PDUFA fees, have [those] dollars go to support the entire agency, where the emphasis is not so much on performance but on quality goals.”
Source: PubMed Central
Author: John Carroll
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W1420365319