Health and Human Services Secretary Kathleen Sebelius and US Food and Drug Administration Commissioner Margaret A. Hamburg announced this week the formation of a new Transparency Task Force at FDA. The task force, which is chaired by FDA Principal Deputy Commissioner Joshua Sharfstein, will provide recommendations about how to make FDA’s operations and decision-making more transparent to the public. As part of that effort, FDA launched this week an open blog to gain input from the public and will be holding a public meeting later this month.
The establishment of the task force follows President Barack Obama’s memorandum, issued in January 2009, that directed 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. In addition to Sharfstein’s role as chair, the task force will include FDA’s center directors, the associate commissioner for regulatory affairs, chief scientist, and chief counsel. The goals of the task force are to:
• Seek public input on issues related to transparency
• Recommend ways that the agency can better explain its operations compatible with the appropriate protection of confidential information
• Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals
• Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision-making to the public
• Identify appropriate tools and new technologies for informing the public
• Recommend changes to the FDA’s current operations, including internal policies and guidance, to improve the agency’s ability to provide information to the public in a timely and effective manner
• Recommend legislative or regulatory changes, if appropriate, to improve the FDA’s ability to provide information to the public
• Submit a written report to the commissioner on the Transparency Task Force’s findings and recommendations.
To gain input from the public, FDA is using the traditional vehicles of the comment-submission procedures of the regulatory process (comments may be submitted at www.regulations.gov through Aug. 7. 2009) and public meetings (first meeting is scheduled for June 24, 2009 in Washington, DC), but is adding a new dimension, a public blog that will run through November 2009.
So what does the public have to say thus far? Initial feedback has been mixed. Some comments are supportive of efforts to increase transparency and communication. Others, however, remain skeptical about whether increased transparency will assist FDA in effectuating true improvement in overseeing drug and food safety. Also, some raise the possibility of dividing the agency into two agencies, respectively regulating food and drug safety. A full listing of comments may be found at the FDA blog, but here is a sampling:
• “The Obama Administration is to be highly commended for their righteous efforts in assembling a team at HHS and the FDA who will strive to improve the transparency of our federal agencies to the American public. Based on prior events, the trust of the public with the actions of the FDA has been waning in recent years.“
• “The FDA has a tough job ahead of itself. It has to provide safeguards for society against crude forms of food and drug adulteration (i.e., filth and lack of quality in manufacturing) while also spearheading the future as it may relate to drugs/products of the 21st century (i.e., drugs customized based on a persons physiology and genetics). These two areas require different resources and approaches. The first is heavily dependent on inspections and ‘being there’ while the second requires a rare brain trust. The prior commissioner was a proponent of the second while not putting resources into the former (hence the problems due to lack of inspections and enforcement of GMP). I doubt that transparency will help. It may be time to split the agency so that the groups can properly focus on different areas.”
Let us know what you think.