On 11 October 1988, AIDS activists shut down the headquarters of the Food and Drug Administration, protesting that the agency was dragging its feet on approvals for promising new drugs while thousands of patients were dying. Days later, the FDA announced historic new regulations that would speed up the approval process for promising new medical products addressing unmet medical needs.
Since then, in response to pressures from legislators, patient advocates, and pharmaceutical companies, the agency has continued to develop a variety of fast-track pathways that expedite the approval of new drugs and medical devices.
Many are concerned, however, that the FDA has overcorrected. At a 13 June event at AAAS headquarters in Washington D.C., experts described examples of harmful drugs and devices that had reached the market and suggested that the bar to public safety has dropped below an acceptable level. The meeting was co-sponsored by AAAS, the Program on Regulation, Therapeutics, and Law within the Division of Pharmacoepidemiology and Pharmacoeconomics of Brigham and Women’s Hospital/Harvard Medical School, and the National Center for Health Research.[…]
More than 90% of all new medical devices are not tested in clinical trials at all, according to Diana Zuckerman, president of the National Center for Health Research. And, when Rita Redberg, a cardiologist at the University of California, San Francisco School, investigated the approval of cardiovascular devices in the highest-risk category over an eight-year period, she found that only one third was approved on the basis of a randomized clinical trial.
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