congessactstoimprovedrugsafety

CONGRESS ACTS TO IMPROVE DRUG SAFETY—BUT LAW FALLS SHORT

This past summer saw a perfect storm as the growing number of drug safety debacles of the past several years (Vioxx, Paxil, Ketek and Avandia, to name a few) collided with the pressing need to reauthorize the collection of user fees from industry in order to keep the FDA functioning. (User fees, paid by drug companies to the FDA to speed up the drug approvals, is one of those bad ideas written into law years ago). The perfect storm actually provided a unique political opportunity for Congress to propose legislation requiring a certain portion of user fee be earmarked to monitor the safety of new drugs once they go on the market. This proposal, signed into law last month by President Bush, is somewhat surprising as similar attempts over the years to link safety reform to reauthorization of user fees have always failed.

The law earmarks several hundred million dollars in user fees for beefed up drug safety surveillance over the next five years, but that is still only about a tenth of the money available for speeding up the FDA process for getting new drugs on the market. Today fees from industry deposit over $400 million a year to the FDA coffers, more than a fifth of the agency’s budget.

The importance of monitoring drugs once they go on the market was underscored recently by a study documenting a disturbing increase in serious injury and death attributable to prescription drug use. Thomas Moore and Michael Cohen of the Institute of Safe Medication Practices, and Curt Furburg of Wake Forest University School of Medicine, analyzed all serious and fatal drug adverse events reported to the FDA’s MedWatch database from 1998 through 2005. They found that serious and fatal adverse drug events had increased by 2.6 and 2.7 fold respectively during that period.

These findings, published in Archives of Internal Medicine, led Moore and colleagues to conclude that “substantially growing numbers of patients are experiencing serious injuries from drug therapy,” and call for “far-reaching legislative, policy and institutional changes.”

Unfortunately, the new safety measures just passed by Congress hardly qualify as “far-reaching.” In addition, the “policy and institutional changes” called for by Moore and colleagues, which echo recommendations in a 2006 Institute of Medicine (IOM) report on FDA and drug safety, is, at least according to one expert, in limbo. In her New England Journal of Medicine article entitled, “Sidelining Safety—The FDA’s Inadequate Response to the IOM,” Sheila Weiss Smith, PhD, associate professor, University of Maryland School of Pharmacy, is strongly critical of FDA’s current leadership and its continued marginalization of safety concerns. According to Smith, “By pitting safety directly against ‘access and innovation,’ the agency betrays its mandate to ensure that U.S. drugs are both safe and effective.”

Don’t assume that the new law and all the attention focused on drug safety of late have made the FDA any better equipped to protect the public from harmful drugs. On the plus side, the FDA has recently launched a free monthly drug safety newsletter to help prescribers and the public keep up to date with safety concerns. It can be accessed at http://www.fda.gov/cder/dsn/2007_fall/2007.pdf .

Consumers should also take greater responsibility for reporting adverse drug events to the FDA MedWatch data base. Moore and colleagues calculated that only about 25% of the reports come from users. The MedWatch report form can be downloaded or filed electronically by visiting http://www.fda.gov/medwatch/report/consumer/consumer.htm.