Transparency at the Food and Drug Administration (New Eng Jour Med)

[pinto]

Note - Authors are officials with the FDA's Transparency Initiative / Transparency Task Force ~ pinto

http://healthcarereform.nejm.org/?p=3440&query=OF

Transparency at the Food and Drug Administration
Afia K. Asamoah, J.D., and Joshua M. Sharfstein, M.D.

On his first full day in office, President Barack Obama issued a memorandum calling for “creating an unprecedented level of openness in Government.” The Department of Health and Human Services embraced this goal, and in June 2009, the new commissioner of the Food and Drug Administration (FDA), Dr. Margaret Hamburg, announced a major transparency initiative. The goal of this initiative was to better explain the FDA’s actions by providing information that supports clinical medicine, biomedical innovation, and public health.

The FDA already makes substantial amounts of information about the regulatory process for medical products publicly available. For example, extensive summary data on drugs and devices are released for public advisory committee meetings before approval, and detailed reviews of drugs are released after approval. However, many aspects of the FDA’s work remain unknown to the public. Few people understand the basic processes followed within the FDA, such as how the agency monitors medical products for safety after they have been approved or how the device-approval process works for products in various risk categories.

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Through its transparency initiative, the FDA has considered a wide range of options for increasing transparency about these and other aspects of its work. The agency has held two public meetings, participated in multiple listening sessions, launched an online blog, and established a docket (public record) to solicit ideas from the public. The agency has received more than 1500 comments.

A task force that includes senior leaders at the agency has reviewed the public input and discussed how best to balance the important and often dueling considerations of transparency and confidentiality. With the support of Dr. Hamburg, the agency is moving forward to implement a series of changes and propose others for further public dialogue.

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More than 30 years ago, FDA Commissioner Donald Kennedy noted “a basic principle of our political system that people affected by governmental decisions have a right to know the basis on which they are made.” With the daily practice of medicine routinely affected by the decisions of the FDA, the medical community has a large stake in transparency at the agency. The full set of draft proposals can be found on the FDA’s Web site (www.fda.gov/transparency). The agency is accepting comment on the proposals until July 20, 2010.

<full NEJM article at>

http://healthcarereform.nejm.org/?p=3440&query=OF

Source Information

Ms. Asamoah is the director of the FDA’s Transparency Initiative, Silver Spring, MD, and Dr. Sharfstein is the FDA’s principal deputy commissioner and chair of its Transparency Task Force.

© 2010 Massachusetts Medical Society