Critics of FDA User Fees Shoot for Reform by Congress

April 13, 2007

BOSTON -- Hefty user fees from pharmaceutical companies account for some 40% of the FDA?s budget for new-drug reviews, but this scheme that spurs speedier approvals worries safety watchdogs.

BOSTON, April 13 -- Hefty user fees from pharmaceutical companies account for some 40% of the FDA's budget for new-drug reviews, but this scheme that spurs speedier approvals worries safety watchdogs.

Three opinion articles, issued by the New England Journal of Medicine ahead of a scheduled April 26 publication, tried to drive those concerns home. The so-called perspectives were aimed at Congress, which is reviewing the law that set up the user fees. The law is set to expire in September unless it is reauthorized now.

For instance, one of the perspectives, written by Jerry Avorn, M.D., a professor of medicine at Harvard, pointed out that the 5% of the user fees permitted to go to postmarket surveillance is not even enough for a single study to investigate the cardiovascular safety of drugs used to treat attention deficit disorder.

Dr. Avorn asserted out that the FDA is unique in that it is the only regulatory agency that works "so cozily" with a trade group that represent the industry, in this case Pharmaceutical and Research Manufacturers of America.

In his article, Dr. Avorn called for Congress to sever this relationship by requiring that "the FDA's drug-related work to be funded by general federal revenues, rather than by the industry it regulates."

The original law, enacted in 1992, allowed the FDA to levy user fees on drug companies, yet barred it from using those fees to monitor post-marketing safety. The law was re-authorized in 1997 but when Congress re-authorized it in 2002, about 5% of the fees were earmarked for post approval safety monitoring.

Dr. Avorn said that when the law was created in 1992 the FDA was regularly criticized for being too slow to approve new drugs-especially new AIDS drugs. In that climate, user fees seemed an ideal solution to eliminate perceived inefficiencies of government and speed up the FDA pipeline. The legislation established strict time limits for drugs to wend their way through the FDA process,

This time around, the FDA asked Congress to set aside 6.7% of the user fees to fund postmarketing studies. But in a perspective he co-authored, Brian L. Strom, M.D., M.P.H., of the University of Pennsylvania found that unsatisfactory.

"We agree with Dr. Avon's position that ideally all funding should come from [general revenues], but practically speaking that is not going to happen at a time of budget deficits," Dr. Strom said in an interview. "So what we are proposing is that Congress earmark more funds for the FDA to conduct its own safety studies-probably a number like million."

Dr. Strom and his University of Pennsylvania colleague, Sean Hennessy, PharmD., Ph.D., pointed out that under the current proposal the FDA is asking that .3 million of the .8-million it expects to collect in user fees in 2008 to be used for modernizing and transforming the drug-safety system.

To put that in perspective, they pointed out that Americans spent .5 billion on prescription drugs in 2004 and drug companies spent about billion advertising prescription drugs that same year.

Yet the FDA could not afford "even a single large study of one recently noted safety signal that has major public health importance-the indication of possible cardiovascular risk posed by drugs for attention deficit-hyperactivity disorder," they wrote.

In the third article, former FDA commissioner Mark McClellan, M.D., Ph.D., argued that the most effective fix for the FDA would be an overhaul of the postmarketing system by making use of available technology.

Dr. McClellan, now a visiting senior fellow at he AEI-Brookings Joint Center for Regulatory Studies in Washington, said that with electronic prescribing information and "the availability of increasingly detailed data on health care utilization and outcomes for insured Americans, we could implement a routine, systematic approach to active population-based drug surveillance that could identify potential safety problems much more effectively and relatively inexpensively."

Instead of the five years that it took to reveal the excess cardiovascular risk seen with rofecoxib (Vioxx), a "statistically significant 'signal' of serious cardiovascular risk could have been detected after less than three months of experience with rofecoxib" by the use of a now-feasible electronic surveillance network, with information on 100 million patients, he wrote.