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FDA Seeks Your Suggestions for Increased Transparency

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The FDA has established a Transparency Task Force, and has called for public comment. We certainly applaud this as a hopeful sign. Openness in government is imperative, and prompt disclosure to the public of government activity ensures legitimacy and accountability.

New FDA Commissioner Margaret Hamburg announced that she created the task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months.

The FDA has long operated under strict confidentiality rules. Its scientists routinely handle reams of private information from drug companies, medical device manufacturers, even laboratories working on genetically engineered animals. The clinical data is critical for government experts to make decisions about the safety and effectiveness of products that could be sold to the public.

It has been argued that improper disclosure—for example, to a competitor—can severely damage a company laboring to bring a new product to market. But Hamburg said she believes the need for secrecy may have been taken too far, and is harming the FDA’s credibility within the medical community and among consumers.

In the past few years, the FDA has been criticized for taking too long to disclose safety concerns about many drugs, including antidepressants, Vioxx (a painkiller) and Rezulin (a diabetes drug). Antidepressants now carry strong warnings about suicide risks for youths; Vioxx and Rezulin were withdrawn from the market. Critics say lives could have been saved if the agency had opened up.

Hamburg said the task force will seek the views of a broad range of interested parties, including industry, medical researchers, and consumer groups. She expects the FDA will be able to act quickly on many of the recommendations. In some cases, however, the agency may have to rewrite regulations, or even ask Congress to change laws that restrict release of information.

Consumer groups applauded the FDA’s search for a new direction. Information on safety and effectiveness should be released routinely so it can be analyzed by independent scientists, said Dr. Sidney Wolfe, director of Public Citizen’s health research group. “There is still an enormous amount of information that’s considered trade secrets,” said Wolfe. “Are doctors and patients fully aware of the risks and benefits of a drug? Certainly not if the data is kept secret.”

The drug industry said, rather predictably, that while it’s not opposed to disclosure, the pendulum could swing too far, undermining competition to develop new medicines.

As you know, we have been sharply critical of many of the the FDA’s actions, particularly in their support of pharmaceutical giants, not to mention their draconian suppression of the scientific proof behind supplements. And we firmly believe that the FDA needs to be rebuilt from bottom to top. To that end, we invite you to be part of our ReformFDA campaign, and add your name to the petition calling for extensive changes at the Food and Drug Administration.

At the same time, we feel this call for public comment is an excellent opportunity for you to provide recommendations to FDA regarding increased transparency about its activities and its decisionmaking process. That’s why we’ve created a new Action Alert to help you send FDA your comments. On our Action Alert page, we tell you how to contact the FDA, discuss in greater depth the issues involved in transparency, and offer concrete suggestions for topics to include in your letter, or thoughts to include in your statement if you choose to appear at the hearing in person.

Let your voice be heard!

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