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Transparency at FDA: A Work in Progress

A mantra of the new Administration is that government needs to be transparent. While the goal is laudable, the scope of the task is often ill-defined and everyone has their own ideas about what transparency means. FDA’s efforts must be viewed as a work in progress that may stretch over years.

The agency has gotten off to a good start with a transparency task force, chaired by Principal Deputy Commissioner, Dr. Joshua Sharfstein. In an earlier post, I addressed some of the likely outcomes of the task force’s work: http://www.fdamatters.com/?p=285.

What I didn’t discuss at the time were some key issues the Task Force needs to address. Here are my thoughts:

Information is not transparent if it is available, but can’t be found. There are hundreds of thousands of pages of information that are publicly accessible from the FDA website. This number will grow steadily as additional archival documents and newly generated materials are posted.

It can be very hard to find what you want in this mass of information. The new FDA website is an improvement. Yet, the homepages for the FDA and the Centers are too cluttered….and not organized to easily get the link you want. Until the agency home pages deliver information effectively, FDA needs to highlight the search functions on the site.

Information is not transparent if it cannot be accessed in a timely fashion. Freedom of Information Act (FOIA) requests often take months to be settled. Expanding the range and depth of materials on the website will help. Still, FOIA requests should be acknowledged within 10 days and a very high percentage fulfilled within 30 days.

Information is not transparent if it isn’t readily available to the media. There is robust coverage of FDA in general circulation and trade publications and in new media (such as this blog). However, veteran FDA reporters, such as Jim Dickinson, tell me that access to agency information and FDA subject matter experts has narrowed considerably over the last 15 to 20 years. FDA needs to remove barriers to access by journalists. For most people on most topics, the media is their source of information on agency activities.

Some of FDA’s transparency policies should be based on “lessons learned” by other government agencies. In particular, state governments have already converted to a more open, user-friendly approach. There are dozens of organizations that have comparable amounts of information stretched across hundreds of topics, yet have confronted and conquered the website clutter problem.

Other policies need to recognize FDA’s uniqueness. It is a public health agency, a scientific agency and a regulator. It oversees products that represent a quarter of consumer spending. It is a repository of confidential business information with a collective value that probably exceeds $100B. Balancing these proprietary concerns with public health needs is likely to be the most difficult part of the task force’s mission and may not be finalized any time soon. While this is being resolved, FDA could improve agency transparency by addressing the three issues I have raised above.

Transparency is a state of mind. It may take considerable time before “open” and “available” become the default choice of federal government agencies. It is certainly not in FDA’s cultural or institutional DNA to be transparent. FDA’s progress can be measured in days and months, but comprehensive policies may still take years.


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