FDA final week issued new rules that purpose to ascertain 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 pharmaceutic and medical device companies must rush out safety updates on products entirely if there is clear evidence of a risk of infection not til now reviewed by FDA. The Pharmaceutical Research and Manufacturers of America supported FDA's actions, expression the new rules provide clarity more or less drug word of advice 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 summation, the American Association of Justice aforesaid 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 pickings away consumers' right to sue would also take away a strong motivator for the FDA and the pharmaceutic 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 eugene Sue will keep federal agencies and manufacturers more honest -- and the public more protected" (Las Vegas Sun, 8/23).
Reprinted with kind permission from hypertext transfer protocol://www.kaisernetwork.org. You can thought the total Kaiser Daily Health Policy Report, lookup the archives, or sign up for email delivery at hTTP://www.kaisernetwork.
