Researchers have recently reported increased prescription drug safety issues since 1992, when the Prescription Drug User Fee Act was implemented.
The Prescription Drug User Fee Act (PDUFA) was designed to accelerate the drug approval process at the Food and Drug Administration to make drugs more readily available by imposing user fees on Pharmaceutical companies to pay for the regulatory review of new medicines.
Because the FDA had not received sufficient appropriations from Congress to hire additional staff, Pharmaceutical companies had to wait to begin to recoup the costs of research and development. At the same time, demonstrating AIDS activists desperate for new treatments and outraged at the cost of drugs approved for the treatment of HIV/AIDS provided a driving force behind enacting PDUFA.
Since the Act was implemented, drug approval times have been cut in half. A recent study now finds an increasing number of FDA-approved prescription drugs that have received black-box warning labels or were later withdrawn from the market because of safety concerns.
Between 1999 and 2009, prescribers wrote 30 million prescriptions for nine drugs that were later withdrawn for safety reasons or received black-box warnings for their potentially deadly side effects. The investigators concluded that almost 27 percent of drugs approved since the law’s passage got black-box warnings or were pulled from the market within 16 years, compared with about 21 percent before.
The study suggests a need for reforms to reduce patient exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was only recently approved.