FDA to Study Ways to Be More Open With Public

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In recent years, the FDA's credibility has been damaged over a variety of perceived missteps.

Problems have included the belated decision to remove the painkiller Vioxx from the market long after clinical data showed it increased the risk of heart attack. Another series of problems arose recently over the FDA's oversight of the nation's food supply. Contaminated pet food and other products from China, salmonella outbreaks stemming from the import of Mexican peppers, and the discovery of salmonella-laced peanut butter made in a U.S. plant have called the agency's ability to safeguard consumers into question.

These and other problems have highlighted budgetary limitations at the FDA, including the need for more regulatory staff.

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Dr. Sidney M. Wolfe, acting president of the consumer watchdog group Public Citizen, welcomed the agency's desire to become more transparent, especially as it relates to disclosing clinical trial data on new drugs.

"For something like 36 years, through litigation and every other means, we have been trying to expand access to data on drug safety and efficacy," Wolfe said.

Wolfe thinks that the FDA needs to make access to that information a permanent policy. Some of these changes can be made by the agency directly, while others will require Congressional action, he noted.

"To make access to clinical trial data [happen] much sooner is a great idea for the public, for everyone that's involved," Wolfe said. "It's anti-scientific and anti-intellectual to have these important data secret."

More information

For more on the U.S. Food and Drug Administration, visit the U.S. Food and Drug Administration.

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