Washington, DC - This week, the House of Representatives overwhelmingly passed legislation to enact important reforms at the Food and Drug Administration (FDA). The bipartisan vote of 403-16 on the FDA Amendments Act of 2007 (H.R. 2900) underscored the widespread congressional desire to address safety lapses and place a greater regulatory emphasis on the monitoring of drugs after FDA approval.

When the news broke in 2004 that the FDA had been aware of serious cardiac side effects associated with Vioxx, it became clear the FDA had failed to meet its mission of ensuring the safety of the nation’s drug supply. Many of the problems at FDA have been attributed to a work culture that stressed drug approval, with little attention paid to the safety of drugs after they are marketed to the public. The bill passed by the House this week would correct that bias through the creation of a new Risk, Evaluation, and Mitigation Strategy (REMS) program.

Under the REMS program, the FDA would establish a safety profile for approved drugs. Included in the profile would be the mandatory surveillance and monitoring of adverse events so that safety problems could be quickly identified and effectively addressed to protect the American public from any dangers associated with a particular prescription drug.

Congressional investigations into post-market drug safety activities also shed light on the FDA’s lack of authority. In the case of Vioxx, the FDA could not warn patients and physicians about the danger of heart attack or stroke. Rather, the agency was forced to rely on a drug sponsor’s willingness to voluntarily disclose potential dangers. The bill passed by the House this week rectifies this problem by giving the FDA the express authority to demand that drug sponsors update labels to reflect safety concerns.

The bill also gives the FDA authority to mandate post-market safety studies. Upon its pre-market approval of a drug, the FDA often requests that the drug sponsor conduct additional safety studies. However, the agency currently has no enforcement mechanism to ensure that these studies are completed. In fact, the FDA reported last year that drug sponsors had not even begun 71 percent of the post-market studies they promised to conduct.

This bill would impose heavy fines of up to $250,000 for each violation of safety standards, including the failure to complete post-market studies. These are hefty but necessary fines that signal the seriousness with which Congress and the FDA view safety violations.

In Congress, we have a duty to protect the public interest. Those interests include both patient safety and speedy access to lifesaving therapies. This bill strikes the appropriate balance between those interests and proves that the ongoing discovery of new pharmaceuticals does not have to come at the expense of patient safety.