FDA last week issued new rules that train to ensure medication warning labels bring home the bacon clear and concise information to consumers, the AP/Denver Post reports. The raw rule, which will claim effect succeeding month, states that pharmaceutical and aesculapian device companies must haste out safety updates on products only if in that location is sack evidence of a peril not still reviewed by FDA. The Pharmaceutical Research and Manufacturers of America supported FDA's actions, saying the new rules allow for clarity some 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 increase, the American Association of Justice aforesaid the fresh rules ask an unneeded 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 hold away a strong bonus for the FDA and the pharmaceutic industry to be open about a drug's voltage 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 slump in their labeling, even when the risk of lawsuits has been award." The editorial concludes, "Preserving the right of consumers to eugene Sue will maintain federal agencies and manufacturers more honest -- and the public more protected" (Las Vegas Sun, 8/23).
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