I am honored to testify in these hearings on the drug safety and the Food and Drug Administration. Since the Merck Company voluntarily withdrew its pain reliever Vioxx from the U.S. and other markets worldwide on September 30, 2004, the FDA has come under intense criticism for its handling of drug safety. Much of this criticism arose from a series of events involving the Cox-2-inhibitor class of pain relievers (Vioxx, Celebrex, and Bextra), the SSRI class of antidepressants (where the possibility of suicidal behavior is the main issue), the diabetes drug Avandia (involving excess adverse cardiovascular events in clinical trials), the antibiotic Ketek, and others.

Some observers have suggested that we face an ongoing crisis in drug safety and that the FDA lacks the determination and institutional tools necessary to deal adequately with drug safety (Avorn 2007; Curfman, et al. 2006; Fontanaros, et al., 2004; Furberg, et al., 2006; Hennessy and Strom 2007; Kohn and Bor 2004; New York Times, September 28, 2006; Okie 2005; Psaty and Furberg 2005; Smith 2007; Strom 2006; Topol 2004b). Among the FDA's alleged problems are weak leadership, weak incentives to give due weight to drug safety, an institutional structure ill-designed to deal with drug safety before and after drug approval, and a lack of resources. Although the FDA Amendments Act of 2007 (FDAAA) was designed to address many of the problems, vigorous criticism of the FDA continues.

I believe these criticisms are largely unfounded. On the whole, the FDA is giving adequate, and indeed, more than adequate weight to safety in its deliberations over drug development and approval and in its handling of approved drugs in the marketplace. This was true before passage of FDAAA and it remains true today. To be sure, changes at the FDA and in the entire health care sector could improve drug safety at reasonable cost, but that does not mean that the FDA has been neglectful.

John E. Calfee is a resident scholar at AEI.

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