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Commentary

FDA goes straight to press
Dr. Scott Gottlieb, USA Today, 5-11-05

Gottlieb worries that the FDA’s new approach to drug safety—quickly releasing public health advisories to the media when they become aware of potential problems—generates public anxiety before the risks are well understood or communicated to doctors.

No doubt, this approach is the agency's response to critics, but a press release is no place for a regulatory agency to flex its muscle. FDA is absorbed in an atmosphere that emphasizes managing drug risks over maximizing overall public health benefits. The agency's response to its critics is to move away from carefully tempered scientific statements made mostly on drug labels and through "Dear Doctor" letters and toward the bully pulpit. The agency is also issuing press releases that shine a spotlight on "emerging risks" rather than focusing on scientifically proven drug side effects. Critics eager to see a tough FDA may be assuaged by hard-talking headlines, but…shotgun warnings fall indiscriminately on both the right and wrong ears. …
All drugs have certain risks, so when regulators choose to highlight one in the press, it should be for good reason. Too much information, especially when it is poorly conceived or scientifically shaky, can be as bad as too little. Overstating a product's risk can discourage legitimate use, too.


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