FDA Basics Brings the Agency Out of the Closet


FDA, on Tuesday, revealed the first phase of its new transparency plan—a three-part initiative designed to reveal the inner workings of one of the US government’s most secretive entity. The initiative was the brainchild of new FDA Commissioner Margaret Hamburg, and follows President Obama’s lead on making government actions more obvious to lay people.

A report from an internal task force outlined the three-phase approach to transparency. “The level of engagement from all sectors involved in FDA has been really impressive, and the agency has spent much time reviewing comments,” said Joshua Sharfstein, principal deputy commissioner of food and drugs.

During a conference call, Sharfstein demonstrated FDA’s new Web-based tool to help the public understand just what the agency does and how it does it works.

“This is the first step towards making useful and understandable information about FDA more accessible to the public,” Sharfstein said. “During phase two, we intend to make recommendations to the commissioner about how to make information about agency activities more transparent, useful, and understandable in a manner that’s compatible with our goal of protecting confidential information.”

Phase two will focus on information FDA has in its possession that’s not accessible at this time, and information that should be made available to the public. Finally, the task force intends to make recommendations to the commissioner regarding FDA’s transparency to regulated industries. For example, Sharfstein said that companies are interested in understanding more about where their applications stand in the approval process.

The new Web site, FDA Basics, was not something the agency originally intended to create, but it was spawned by numerous comments asking for more insight into what FDA really is and what it does.

“We know so much about commercial products, but we don’t know much at all about government agencies and how they work,” Sharfstein read from a list of comments. “In general, people don’t know the process a product must go through at the FDA to be approved.”

FDA Basics includes answers to frequently asked questions about the agency and short videos featuring personnel. “The goal is to open up FDA to the public so that people can understand how FDA works, and meet the people that work at the agency,” Sharfstein said. The centers and offices within the agency plan to host online sessions where the public can learn about topics and ask questions directly to officials.

The second phase is expected to start by the end of February. “There’s a lot of work going on as these are enormous, complex issues,” Sharfstein said. “And there’s a lot of consideration being given on all sides of the question.”