An FDA proposal for improved transparency

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In a 67-page proposal for a way forward toward more transparency, a U.S. Food and Drug Administration task force suggested broad changes that would increase public access to information about the oversight and regulatory process for everything form pharmaceuticals and food products to medical devices and tanning beds.

The FDA Transparency Task Force, created last summer, is chaired by Deputy FDA Commissioner Dr. Joshua Sharfstein and includes agency directors, lead scientist and attorney, and the associate commissioner for regulatory affairs. The group released the initial draft proposals (PDF) this week, inviting public comment through July 20.

Among the 21 changes included in the task force draft proposal are: increased disclosure of information about drugs that have been put on hold, terminated or withdrawn and what the reason was for this; more open access to decision letters about products or drugs that have not met agency approval; access to improved information about timing and results of facility inspections; and efforts to improve clarity about the specific products affected by large-scale food recalls.

The task force is part of a bigger transparency initiative launched last summer by the U.S. Department of Health and Human Services, which led to the creation of a web site specifically dedicated to improving public understanding of the function of the FDA this past January, as well as the creation of a performance measurement program called FDA Track this past April.

In a commentary published this week in the New England Journal of Medicine, Sharfstein and transparency initiative coordinator Afia K. Asamoah write that the third major component of the transparency initiative, these proposed changes, would not only increase public access to information — through efforts aimed at improved disclosure and clear advisories about the limits of information available — but could also expedite the development of potentially life-saving drugs and devices. As they write:

One proposal, for example, would allow the FDA to explain that an orphan drug whose application was abandoned or withdrawn … may nevertheless represent an important therapeutic advance for a rare disease. This information would be of substantial interest to patients with that disease, their families, and their clinicians. It could also encourage additional investment for development of that drug or provide another company with the incentive to purchase and continue with the application.

In the NEJM commentary — and on the cover of the 67-page draft proposals report — the authors refer back to 1978 remarks made by then-FDA commissioner Donald Kennedy, who said that a basic principle in our political system is:

“… that people affected by governmental decisions have a right to know the basis on which they are made. Anyone who questions the wisdom of a regulatory decision should be able to examine the factual foundation of the decision.”

The full draft proposal report can be seen here (PDF). Public comments are invited through July 20.