Mar. 23 -- FRIDAY, April 13 (HealthDay News) -- Controversy continues to engulf renewal of the Prescription Drug User Fee Act (PDUFA), with the key issue being whether the law does enough to protect U.S. consumers from potentially harmful drugs.
The act was passed by Congress in 1992 to establish "user fees" that are paid by drug companies to the U.S. Food and Drug Administration to review and vote on new drug applications. In 2008, these user fees are expected to total $438 million and account for more than 42 percent of all the money the FDA receives for regulating drugs.
Now, several sides of the debate are expressed in a trio of opinions that will be published in the April 26 issue of The New England Journal of Medicine; the articles were released Friday to coincide with public debate on the issue.
Opinions about PDUFA, which has to be renewed every five years and is set to expire Sept. 30, vary. They range from those who think the user fees make the FDA too cozy with the drug companies, leading to compromised drug safety, to those who believe the funds are essential to the FDA. Still others think that more of these funds should be spent on drug safety than is currently planned by the FDA.
One of the NEJM articles, co-authored by Sean Hennessy, an assistant professor of pharmacology and epidemiology at the University of Pennsylvania School of Medicine, argues that more of the PDUFA money should go to FDA-funded drug safety studies once medications have been approved, to monitor their safety in the marketplace.
"FDA has dramatically insufficient resources to perform or commission post-approval safety studies," Hennessy said. "As a result of this, the American people rely almost exclusively on pharmaceutical companies to fund the research to identify the risks associated with their own products."
Hennessy noted that the current plan is to spend only $29.3 million of the almost $438 million in PDUFA fees for drug safety. "This is in stark contrast with the $12 billion spent on marketing prescription drugs each year," he said. "FDA should be provided with the resources so that they have to rely less on industry to study the risks associated with prescription drugs."
In another article, Dr. Jerry Avorn, a professor of medicine at Harvard Medical School and chief of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital in Boston, states that renewal of PDUFA should be predicated on fixing what he sees as the dangerous shortcomings in the law. In particular, he is calling for more requirements for safety studies and better oversight of adverse drug effects.
Ultimately, Avorn would like to see the FDA's drug-related work funded by monies from federal revenues, not the drug industry.
"We are learning that the PDUFA is having important negative, unintended consequences," he said. "Drugs are being rushed through, not getting the attention they deserve. And the culture within the FDA has changed, seeing industry as the client they need to please.
"People within FDA say they feel they are under pressure to not find safety problems with drugs, and make approval decisions they would not have made if they were not under the gun," he added.
Avorn also thinks that if the law is renewed, the renewal should only be for a maximum of 12 months to allow time for a debate on the legislation and the current relationship between the drug industry and the FDA.
In a third article, former FDA Commissioner Dr. Mark McClellan, now a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington, D.C., says he supports renewal of PDUFA. But he also calls for congressional funding of the FDA to increase the dollars needed to improve drug safety.
The issue of drug safety exploded into the public's consciousness in 2004 when the arthritis drug Vioxx was removed from the market after post-approval studies found that it increased users' chances of heart attack and stroke. The FDA also faced sharp criticism from some quarters over the possible link between the family of antidepressants called selective serotonin reuptake inhibitors (SSRIs) and suicidal thoughts and actions in children.
One critic of PDUFA thinks the law should be repealed altogether.
"We have opposed PDUFA since shortly after it passed," said Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group. "FDA seemed to have done well for the first 86 years of its existence with funding coming entirely through the congressional appropriations process."
Once the law was passed in 1992, more drugs started being approved, Wolfe said. "When the FDA views the drug companies as their client, it erodes the adversary relationship. It changes it from being a regulator to being a collaborator," he said. "PDUFA needs to be repealed. It's not workable at all. The FDA is too important to be left to be funded by the industry it's supposed to be regulating."
Concern about drug safety in the United States was fueled by a scathing 2006 report by the U.S. Institute of Medicine (IOM). The report found that there is a "perception of crisis" that has compromised the credibility of FDA and of the pharmaceutical industry.
Drug safety is hampered by serious resource constraints on the FDA that weaken the quality and quantity of the science that is brought to bear on medication reviews, the report said.
In addition, the IOM found that the FDA and the "pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion."
Learn more about PDUFA at the U.S. Food and Drug Administration.
SOURCES: Sean Hennessy, Pharm.D., Ph.D., University of Pennsylvania School of Medicine, Philadelphia; Jerry Avorn, M.D., professor of medicine at Harvard Medical School, and chief of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital, both in Boston; Sidney M. Wolfe, M.D., director, Public Citizen's Health Research Group, Washington, D.C.; April 26, 2007, New England Journal of Medicine; September 2006, Institute of Medicine report, The Future of Drug Safety: Promoting and Protecting the Health of the Public