Regulatory Reform – Changes Needed

The weaknesses of the postmarketing surveillance (PMS) system weren't the only problem the FDA had. Another burning issue was poor supervision of post-marketing studies that were to be conducted in return for an accelerated product review and approval. It was found that the agency had allowed drug companies to renege on performing the postmarketing trials. Analyses indicated that almost half of the promised studies remained unfinished. While the FDA had made enormous strides in improving the time to approve products, it had neglected its postmarket-ing responsibilities. This situation occurred because under a user-fee agreement, the industry paid the FDA to review their marketing application, but the money was only for functions related to those applications. In the meantime, the overall FDA budget was being cut and those reductions had a serious effect on other programs such as PMS. The downfall of Vioxx, a top selling pain drug illustrated the deepening negative image of the FDA. Congressional hearings and press stories painted a picture of overly aggressive drug marketing and negligent regulation by the FDA. Corrective action by Congress led to passage of the FDA Revitalization Act giving the agency the power to deal with many of the postmarketing problems it faced.