This is historical material “frozen in time”. The website is no longer updated and links to external websites and some internal pages may not work.

Search form

Opening Up FDA

Dr. Joshua Sharfstein and Afia Asamoah discuss the ongoing transparency efforts at FDA.

In previous administrations, stakeholders have complained about the FDA’s lack of transparency. The agency used to be considered a "black box" that makes important decisions without explaining them. Following the leadership and commitment of President Obama and HHS Secretary Kathleen Sebelius to transparent and open government, in June 2009, FDA Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to make FDA much more transparent to the American public.

Commissioner Hamburg formed an internal task force representing key leaders of FDA to oversee the initiative. Over the last eight months, the Task Force has held two public meetings, launched an online blog and opened a docket. The online blog and the docket have received over 1,380 comments to date.

Comments from the public first suggested the idea that FDA provide basic information about the agency in an user-friendly, accessible format. As one person stated, "I would like to see the FDA ‘faces behind the curtain’ and what their jobs are. Who IS the FDA and HOW does it work? Make it simple . . ."

Early this year, FDA launched a web-based resource called FDA Basics  to provide the public with basic information about FDA and how the agency does its work. FDA Basics now includes:

  1.  115 questions and answers about FDA and the products the agency regulates (for example, see questions about drugs here)
  2.   7 short videos that explain various agency activities (for example, learn how FDA manages product recalls here )
  3. 7 conversations with agency officials about the work of their Offices

Visitors to FDA Basics can rate on a scale from 1 to 5  how helpful the answers are. And visitors are invited to suggest additional questions as they navigate around the site. We have received nearly 1400 comments since the launch of FDA Basics and are using these comments to update the resource.

Each month, senior officials from FDA product centers and offices host 30 minute webinars about a specific topic and answer questions from the public about that topic. These sessions are announced on the FDA web site and the online blog.

The FDA Basics webinar series was launched in February with a webinar on "Access to Investigational Drugs," hosted by FDA’s Office of Special Health Issues. An audio replay  and copy of the PowerPoint slides are available on the FDA Basics web site. The next webinar on FDA's inspection process will be held later this month. Details about the webinar will be available on the FDA Basics homepage.

Early reaction to FDA Basics has been positive. One blogger wrote, "[t]he initiative can go a long way toward educating the public about what FDA does—and how—and also provide industry with real-time answers to their daily challenges, ultimately improving product quality and patient safety." Another blogger wrote, "[i]t is really well put together, clear and works quite well. . . . The site is not only supportive of transparency, but is highly instructive and educational."

Check out FDA Basics and let us know what you think.

Joshua Sharfstein is Principal Deputy Commissioner at FDA and Chair of the Transparency Task Force. Afia Asamoah is a Special Assistant in the Office of the Commissioner and coordinator of the Transparency Initiative.