Today, the U.S. Food and Drug Administration (FDA) Transparency Task Force is releasing 21 draft proposals aimed at helping consumers, stakeholders, and others understand how FDA works and makes decisions. FDA would like the public to provide feedback on these ideas. After 60 days, FDA will use your comments to make recommendations to FDA Commissioner Dr. Margaret Hamburg for implementation.
Following the leadership and commitment of President Obama and the Department of Health and Human Services Secretary Kathleen Sebelius to transparent and open government, Commissioner Hamburg launched FDA's Transparency Initiative in June 2009. Since then, FDA has held two public meetings, participated in public listening sessions, launched an online transparency blog, and established a public record to accept public comments. FDA has received more than 1500 comments from the public about transparency at the agency. Two major initiatives already have been launched as a result of public suggestions.
Earlier this year, FDA launched a popular new website, FDA Basics, to help better explain the work that FDA does. We also launched a new public performance system called FDA-TRACK to help track the agency’s progress on important projects and programs.
Our next step is releasing this report today. This report has proposals that were developed based on public input. All the proposals are designed to help provide more information to the public while maintaining confidentiality for trade secrets and individually identifiable information.
For example, one proposal is for FDA to explain its reasoning when it declines to approve a medical product. Disclosing this kind of information could help researchers and others in the medical products industry develop improved products for approval.
In another proposal, when a drug sponsor decides for business reasons not to pursue approval for a drug designed to treat a rare disease, FDA would be allowed to explain that the drug could represent a significant therapeutic advance for the disease. That type of information could cause another company to continue with the application or encourage additional investment for the development of the drug.
These are just two of the proposals included in the report. These kinds of proposals will allow the public, Congress, media, industry and many other stakeholders to better understand the health and safety decisions FDA makes each day about foods, drugs, medical devices, cosmetics, and other widely used consumer products. The report also proposes steps FDA can take to open up the agency, including providing more information about the agency’s interactions with the media and the process used to implement the Freedom of Information Act.
You can read more about the transparency report FDA is releasing today in a Perspective article in the New England Journal of Medicine online, "Transparency at the U.S. Food and Drug Administration."
Not all of the 21 draft proposals will necessarily be implemented. Some require extensive resources to implement and some may require changes to regulations or legislation. You can read the draft proposals here and let us know what you think before July 20, 2010. Go to the FDA Web site to provide your input on these proposals and tell us which should be our top priorities.
Beth Martino is the Associate Commissioner of External Affairs at FDA.