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New Study Links PDUFA to More Unsafe Drugs

Since the Prescription Drug User Fee Act (PDUFA) was implemented 22 years ago, a study published in Health Affairs found that 27 percent of drugs received black-box warnings or were removed from the market within 16 years, as opposed to the 21 percent before. According to an article published by CBS News, new drugs have over a 30 percent chance of acquiring a new black-box warning or being pulled from the market for safety concerns within 25 years of approval. These findings are resulting in calls for more stringent regulations on approving drugs, and the need for reformation in order to improve patient safety.

Read the study published in Health Affairs.

Read the article published by CBS News.