Preventing the next Public Health Crisis: New Drug Approval after Vioxx

Abstract

The U.S. Food and Drug Administration (FDA) drug approval system has sought to strike a balance between two goals: ensuring that new drugs are safe enough for human use, while getting therapeutically important medications to the market quickly. The recent withdrawal of Vioxx from the market highlights several deficiencies in the FDA’s drug approval and monitoring system. Scientists at Merck and the FDA knew of the drug’s risks years earlier but failed to act until thousands had died. To protect the public, Congress should authorize additional FDA funding to strengthen the agency’s review system; increase fines for pharmaceutical companies that hide adverse data about their drugs; authorize the establishment of an independent drug safety board for post-marketing surveillance; and ensure that only drugs for serious or life-threatening illnesses receive expedited review.