FDA Circumvents Congressional Intent In Favor Of Drug Companies

Last year, the Food and Drug Administration (FDA) issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), an Act which encompasses the Prescription Drug and User Fee Act. As a result, drug companies will enjoy more relaxed labeling requirements and will surely use the rule to claim immunity for failing to warn patients of potential drug hazards. When Congress passed the FDAAA it included language confirming the responsibility of the drug manufacturer to promptly update its drug label when they become aware of new safety information. Congress was clear that it intended to keep the burden squarely on the drug companies to update warning labels. Nonetheless, the FDA had promulgated this new rule against Congress’ expressed wishes. Congress explicitedly stated that it did not intend to ease the requirements on drug companies to inform consumers of potential drug hazards. It reiterated the need for drug companies to change its label if the drug company learns of reasonable evidence of that risk. In fact, the drug companies fought and lobbied hard to include language to loosen warning label obligations that the Congress specifically left out of the final Bill. But since the drug companies could not get Congress to agree to lessen their responsibilities towards consumers, they turned to the Bush Administration. Unfortunately, the FDA’s tactics are not new to Bush Administration bureaucrats. Unelected federal agencies have been ignoring congressional directives in a number of other cases. The Environmental Protection Agency (EPA), National Highway Traffic Safety Administration (NHTSA), Consumer Product Safety Commission (CPSC), and others are also engaging in this tactic of bureaucratic activism.