FDA Seeks Suggestions on Increasing Transparency

The US Food and Drug Administration (FDA) has formed a Transparency Task Force. It is designed, in their words, “to develop recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format.” More information about the Task Force can be found at the FDA’s website.

AAHF has long expressed concerns over the lack of transparency in all FDA activity—everything from their response to Citizen Petitions to the approval of a new drug or medical device that is “safe for market use.” Open government is essential to ensure accountability and is the important first step in eliminating undue influence and conflicts of interest.

A clear example of the current lack of transparency in this government agency is the action the FDA took regarding the ban on estriol, a natural hormone replacement, in response to a Citizen Petition filed by a drug company. First the FDA failed to hold a public hearing, then they argued they did not have to justify their action to ban estriol even though thousands of women were potentially affected. FDA refused to disclose the information used to reach their decision despite the fact that this hormone has been used by women in the U.S. for decades and even though the FDA could not document a single adverse event with this medication. The agency refused to disclose this information not only to the general public but also to Congress—even after numerous written requests from members of Congress.

The Citizen Petition process drastically needs wide-open government. FDA should disclose all information used in making a decision: all reports, studies, outside consultant data, and correspondence received that assisted the agency in making a ruling on a Citizen Petition. Currently, the FDA releases minimal information about their process, and when they grant Citizen Petitions despite there being no threat to consumer safety, their actions have, at the very least, the appearance of impropriety.

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FDA Seeks Suggestions on Increasing Transparency

Dear  [Decision Maker],

Sincerely,
[Your Name]
[Your Address]
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