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Many Facets to the Transparency Task Force

FDA’s disclosure policies are intended to be a balance between “public right to know” and “company right to protect intellectual property that supports innovations.” As such, every FDA policy has a risk-benefit to society, which evolves over time. Seen in this light, the new FDA task force on agency transparency is a legitimate inquiry. It probably should be repeated every 3 to 5 years.

Compared to products, it is much trickier to figure out when policies need to be changed and based on what criteria. Yet, it is possible, even now, to predict the broad outline of the task force report, due in early December:

Low-hanging fruit: There are policies and procedures whose revision is obvious when subjected to examination. For example, more of the senior people at FDA should be required to keep a public log of meetings with external stakeholders. This is fair as long as it includes contact with any interest group, not just industry.

More substantive changes requiring more work of FDA, but public interest clearly weighs in favor of disclosure: FOIA immediately comes to mind. My experience is to get a call from FDA asking if I want the information —12 to 18 months after a FOIA request. I never have gotten anything in a timeframe where I could use it.

Large changes requiring new policies or major re-working of existing policies: These are likely to invoke heated exchange now, but a year hence, everyone will wonder what the fuss was about. An example from the past: the policy of FDA and company briefing books being posted online two-days prior to an advisory committee meeting.

Major changes requiring legislation: These are the ones widely predicted by media, much feared by industry and least likely to happen. One such
proposal, advocated in a NY Times editorial, would substantially increase the amount of company data made available to the public before and after approval of medical products. Some change in this area will happen, but not much. The legislative barriers are too high, the lack of consensus too great, and caution will prevail because no one can be certain where the proper balance lies.

Hanging over all of this is the need for the agency to communicate better. As Dr. Sharfstein observed, sometimes the agency has a good explanation, but it “doesn’t break through because of FDA’s reputation for being uncooperative.”

As a footnote: the task force exercise itself is going to prove instructive, if only because old habits die hard. A tip of the hat to fellow blogger Mark Senak for pointing out that the transparency task force blog: neither identifies who will be writing and posting blogs nor who will be responsible for accepting and rejecting public comments intended for the blog site. No doubt this will be remedied quickly, but the point is still significant: transparency and accountability are not part of FDA’s DNA. New habits will take time, energy and experience to develop.

The June 3 Federal Register notice for the June 24th public hearing of the Transparency Task Force:


The original NY Times article by Gardiner Harris on June 2:


NY Times editorial on transparency and FDA on June 3:


Mark Senak’s comments: http://www.eyeonfda.com/eye_on_fda

Reported in the June 4, Drug Daily Bulletin (free): enewsletters@fdanews.com

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