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FDA labeling plan a case of a little good news, a lot of bad news

January 18, 2006


Plan fails to improve amount, quality of drug safety information

(Washington, D.C.) – Consumers Union today said it is hopeful the Food and Drug Administration’s labeling proposal will make existing drug safety and risk information clearer to physicians, but said the new plan falls short of dramatically improving drug safety for consumers because it does not require better safety measures from drug makers.
“While it is good news that the FDA is trying to more clearly communicate existing drug information to doctors and pharmacists, it falls short of providing thorough and up-to-date risk information to all of us,” said Rob Schneider, director of a Consumers Union project to improve drug safety, efficacy and affordability.
“Drug companies still are not required to complete promised post-market studies that could tell us whether a drug is safe once it is actually used by millions of Americans,” Schneider said. “And drug companies still are not required to make public the results of their clinical drug studies, so they play up positive results and downplay studies that show harmful side effects.”
He said the FDA should be actively requiring drug manufacturers make this safety information publicly available so all consumers can make informed health-care decisions.
Consumers Union also opposed language in the FDA’s labeling rule that federally approved prescription drug labels pre-empt state liability laws.
“The last several years have seen repeated examples of drug industry deceptions and the reluctance of the FDA to aggressively pursue them. States should be encouraged to step in to protect consumers, not discouraged,” Schneider said. “Rather than offering advice that the states should not act, the FDA should be announcing stronger actions against drug company deception in clinical trials and the failure to fulfill post-market safety commitments.”

Contact: Susan Herold, 202-462-6262