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Prescription for trouble
Consumer Reports, 1-1-06

Consumer Reports has issued a series of articles on drug safety. The editors argue that:

It's up to Congress to plug gaps and give the FDA the tools it needs. Two bipartisan bills, introduced in 2005 by Senators Charles Grassley (R-Iowa) and Christopher Dodd (D-Conn.), would bring significant changes. Neither bill has received a hearing, and similar efforts in the House of Representatives have likewise stalled.

• S. 470 would require drugmakers to register and make public their clinical drug trials to help researchers, physicians, and patients learn of potentially harmful side effects. Currently, negative studies can be hidden from public view.

• S. 930 would give the FDA authority to require drug manufacturers to conduct further safety studies of new drugs on the market, change warning labels, and require that ads be clearer about the risks and benefits.

• Separate proposals would impose a two- or three-year moratorium on ads for new drugs, allowing time for any serious adverse side effects to emerge after a drug hits the market and is widely used.

The editors believe that “the bills before Congress are common-sense reforms that will not slow the introduction of lifesaving drugs and therapies [and] ensure that doctors, researchers, and patients know more, and they let the FDA take meaningful action.”

We respect Consumer Reports (and consult it from time to time). But in this instance they’re off base. The clinical trials that the FDA uses to approve drugs are imprecise, because the statistical power needed to detect rare side effects in a pre-market environment would require incredibly large, prohibitively expensive, and time consuming efforts. The FDA must balance safety and benefits; holding up drugs to detect ever more rare side effects would bring the drug development process to a grinding halt.

Companies are already disclosing significant amounts of clinical-trial data. The best safety information, however, probably won’t be gleaned from clinical trials, but from better real-time monitoring of insurer and hospital databases, and from electronic patient records, which can spot potential problems long before clinical trials would. The FDA is moving forward on this front, and Congress shouldn't step in to second guess the agency in a very complicated area.

The FDA is already working with companies to update drug labeling regulations that would clarify the most important safety risks. The agency is also working with risk-management experts to update its risk communication strategy for physicians and the general public. Additionally, the FDA will soon release its Critical Path opportunities list, which will identify how specific research programs (for liver toxicity, for instance) can help screen out dangerous drugs earlier in drug development. Finally, the Institute of Medicine is conducting (at the FDA's request) a comprehensive review of its drug safety programs.

The safety hurdles that the agency is tackling now are largely scientific and technical. Congress shouldn’t burden the FDA with inflexible regulations that will be technologically outmoded before the ink on them dries.

Project FDA.
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