FDA Weighing Non-Prescription Status for Chronic Disease Drugs
March 9, 2012 The Food and Drug Administration is weighing whether to let consumers buy medicines for some chronic conditions without a prescription while speeding approvals of drugs for infection,Alzheimer’s disease and rare conditions.
FDA Commissioner Margaret Hamburg and the agency’s director of the Center for Drug Evaluation and Research yesterday outlined ways to get drugs in patients’ hands faster. The House Energy and Commerce health subcommittee today will hold a hearing on ways to expand the agency’s accelerated approval program and encourage drugmakers to develop antibiotics.
The FDA plans to expand its accelerated approval program based on relaxed standards for effectiveness, which is now largely limited to AIDS and cancer drugs, said Janet Woodcock, the agency’s top drug evaluator. The agency will also hold a two-day public meeting this month to evaluate whether to reclassify drugs for high blood pressure, cholesterol, migraines and asthma so patients can get them without a prescription.
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