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FDA to reveal more on drug, food safety

/ Source: The Associated Press

The agency that regulates everything from pacemakers to peanut butter would begin publicizing safety problems with the drugs and devices it rejects under a proposal announced Wednesday.

The effort is part of a broader plan to remake the Food and Drug Administration's public image, which has come under fire for being too secretive.

The agency suggested 21 ways the FDA could release more information to the public in areas like drug evaluation and food manufacturing inspections. Agency leadership stressed that the agency is merely considering the changes and that some would require legal changes by Congress to implement.

The FDA has long operated under strict confidentiality rules because its scientists handle reams of proprietary information from food, drug and device companies.

However, that operating style has come under fire in recent years from critics who have charged that the agency is too slow to disclose drug safety issues.

Problems with FDA transparency were highlighted in 2004 when the popular painkiller Vioxx was pulled from the market five years after its approval, because of links to heart attack and stroke. Critics said lives could have been saved if the agency had opened up its files to outside researchers and health advocates.

Half of the new suggestions are designed to give more information about experimental drugs and devices under review at the agency. Under current FDA regulations, communication about such products is extremely limited. In the initial months of review FDA spokespersons will not even confirm the existence of a new drug application. Additionally, when the FDA declines to approve a treatment it allows the manufacturer that make the announcement — which usually comes in the most vague, unspecific terms possible.

Under proposals outlined in a 67-page report, the FDA would begin publishing rejection letters to drug and device manufacturers, including any safety concerns that led to the decision. Such a change would mark an about-face from current policies that allow manufacturers to control public information about products in development.

The Pharmaceutical Research and Manufacturers Association said Wednesday it is reviewing FDA's proposal and generally supports increased transparency.

The group's Senior Vice President Ken Johnson added that FDA must "ensure that the competitive development process remains intact to serve patients and the public."