In announcing a new executive-level internal FDA task force on transparency 6/2, FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein carefully avoided making any references to specific past incidents in which the agency has not been viewed as transparent. They acknowledged that there have been past criticisms, but said their action was part of the Obama administration’s dedication to a greater openness in government and a desire to take a “fresh look” at what information can be made available and the best way to do so.

“Our goal is to take a serious, clear-eyed look at how the agency handles various kinds of information,” Hamburg told a media teleconference. “Is it open enough? Is it clear enough?” An agency news release says the task force responds to a 1/21 memorandum from President Barack Obama directing executive agencies to find new ways of making information available to the public rapidly and in a form that is easily accessible and user-friendly.

Serving on FDA’s task force will be the various Center directors, the associate commissioner for regulatory affairs, the chief counsel, and the chief scientist. Sharfstein will chair the group, and promised that it will use innovative ways to solicit and receive input from the public and stakeholders. The task force is expected to make a report to Hamburg within about six months.

“Over the years there have been complaints about a lack of transparency,” Hamburg said. “FDA has been described as a ‘black box’” in which decisions are made without any information on what led to the decisions. “I believe that we can do a better job of providing useful information to the public in a timely manner.”

A Federal Register notice announces a task force public meeting 6/24 at the National Transportation Safety Board “to solicit recommendations from interested persons on ways in which FDA can make useful and understandable information about FDA activities and decision-making more readily available to the public.” The task force also has established a public docket and will receive written comments and recommendations there until 8/7. A second public meeting is likely to be held in the fall.

Questions to be addressed at the public meeting include:

1.  How can the agency better explain its operations, activities, processes, and decision-making?
2.  What specific information should FDA provide about agency operations, activities, processes, and decision-making, including enforcement actions, product approvals, recalls, and other actions?
3.  What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information, such as Internet tools, tools to improve targeting and effective use of communications including risk communications, and improvements to Freedom of Information Act processes?
4.  What, if any, legislative or regulatory changes are needed to improve FDA’s ability to provide useful and understandable information to the public?
5.  As FDA becomes more transparent, what information should remain confidential to provide key internal and external policy goals, such as preserving patient privacy and how, in these cases, should FDA explain the importance of confidentiality?
6.  What metrics should FDA use to gauge the effectiveness of its transparency efforts?

Hamburg said that she expects to receive a range of recommendations, including some “minor tweaks” to systems that can be implemented quickly, some that may need time to implement, and some that may require changes in laws or regulations. Asked by a reporter for an example of a change that could be made quickly, she would only say that there may be some reports or documents that could be posted on the FDA Web site in a more timely way.

Also, when asked if FDA will have the resources needed to implement any sweeping changes to transparency, Hamburg said that officials will have to look at the recommendations, prioritize them, and develop an implementation strategy.

She said that an essential part of FDA’s public health mission is to provide information that people need to make decisions and also said that increased transparency is “essential to our efforts to restore trust and confidence in FDA.”

Before the media teleconference, Hamburg and Sharfstein held a conference call with a number of stakeholders. They gave the same opening statements they read on the media call and then took questions from stakeholder representatives. They tended to be from advocacy groups, rather than from industry, and all praised the initiative.