FDA panel: Agency should make records of denials public

The Food and Drug Administration's Transparency Task Force has recommended that the agency should make more information available to the public about companies and the FDA's reasons behind decisions not to approve products, Reuters reports. "Wider disclosure could alter companies' ability to control news that could affect their stock prices, especially negative FDA actions such as denying a product or highlighting safety concerns." The FDA's letters to companies detailing why products are rejected were previously only published if a company chose to do so (Heavey and Richwine, 5/19).

"Currently, the FDA only releases information about products it approves and won't comment on what applications are pending before the agency, even if that information has been released by a company," The Wall Street Journal reports. The task force also says the agency should publish inspection reports, which are currently only released in major cases "such as Johnson & Johnson's recent recall of Tylenol for children" (Dooren, 5/19).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.