According to a new report published by the General Accounting Office (GAO), a special investigative branch of Congress, a law that allows the U.S. Food and Drug Administration (FDA) to rush new medication approvals may be responsible for a high rate of drug recalls. Under the Prescription Drug User Fee Act of 1993, pharmaceutical companies pay the FDA to meet tight deadlines to make a
drug available to the public. In the past nine years, the FDA has cut its decision time on whether a new medication is safe and effective nearly in half, from 27 months to 14 months.
Critics argue that the law forces the FDA to focus more resources into approving new drugs, limiting the agency's time for monitoring medications already approved. The GAO report indicates that since 1993, the percentage of drugs withdrawn from the U.S. market for safety reasons has increased by nearly one-half percent. While the FDA agrees that its resources are limited because of the law, the agency says the increases are too small to make a proper conclusion on the benefits of its drug approval process.