FDA Issues New Rules On Product Warning Label Updates For Pharmaceuticals, Medical Devices

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics;  Public Health
Article Date: 26 Aug 2008 - 5:00 PDT

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FDA last week issued new rules that aim to ensure medication warning labels provide clear and concise information to consumers, the AP/Denver Post reports. The new rule, which will take effect next month, states that pharmaceutical and medical device companies must rush out safety updates on products only if there is clear evidence of a risk not yet reviewed by FDA. The Pharmaceutical Research and Manufacturers of America supported FDA's actions, saying the new rules provide clarity about drug warning labels, the AP/Post reports. However, consumer advocacy lawyers said the new rules provide legal protection to companies that withhold information on risks associated with their products. In addition, the American Association of Justice said the new rules require an unnecessary standard of scientific evidence before companies must update their labels (Perrone, AP/Denver Post, 8/24).

Editorial Addresses NEJM Commentary on Pre-Emption
A Las Vegas Sun editorial agrees with the editors of the New England Journal of Medicine "who say that taking away consumers' right to sue would also take away a strong incentive for the FDA and the pharmaceutical industry to be open about a drug's potential for causing harm." According to the editorial, the NEJM editors "state the obvious" that FDA and the pharmaceutical companies "haven't always been completely open or correct in their labeling, even when the risk of lawsuits has been present." The editorial concludes, "Preserving the right of consumers to sue will keep federal agencies and manufacturers more honest -- and the public more protected" (Las Vegas Sun, 8/23).

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