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FDA Forms Transparency Task Force

In recent months, FDA has come under fire from internal agency whistleblowers, lawmakers, and consumer groups, all of  whom allege that the agency’s approval and clearance processes are shrouded in mystery and too lax on the medical device industry.(1)  In particular, critics contend that the premarket notification (“510(k)”) process, through which the vast majority of medical devices are cleared for marketing, is not rigorous enough and allows potentially unsafe devices onto the U.S. market.  In an effort to help the public better understand FDA’s device review process and the rationale behind ostensibly controversial agency decisions, the Obama administration announced on June 2, 2009 that it will form a Transparency Task Force at FDA.(2)

The Task Force will be led by FDA’s Principal Deputy Commissioner Joshua Sharfstein and is tasked with reporting to Commissioner Margaret Hamburg ideas for making information on FDA activities and decisions more readily available and understandable.(3)  The Task Force has six months to produce a written report to the Commissioner recommending which information FDA should publicly disclose and which information should be kept confidential. 

Historically, FDA has been required to keep certain information regarding product approvals confidential because the information is considered proprietary trade secrets.(4)  A host of laws govern FDA’s decisions regarding the confidentiality of product information, including the Federal Trade Secrets Act, under which clinical trial data and FDA’s decision-making rationale have typically been considered trade secrets.(5)  Some vocal critics claim that FDA has been too cautious and kept information confidential that should have been made public, to the detriment of public health and safety.(6)  In particular, critics are calling on the Task Force to recommend public dissemination of clinical trial results, even if doing so would require rewriting current trade secrets laws.(7)  Commissioner Hamburg has not ruled out the possibility that changes to current law may be necessary to facilitate the transparency the Obama administration hopes to achieve.(8)

FDA and its regulated industries recognize, however, that certain information furnished to the agency during the approval process must remain confidential.  Dan Schultz, director of the Center for Devices and Radiological Health at FDA, noted in a recent medical device industry meeting that it will be difficult to promote transparency while protecting the legitimate competitive interests of the device industry.(9)  FDA leaders have all recently intimated, however, that the increased transparency that will result from the Task Force’s recommendations will be crucial in restoring public confidence in FDA and its regulated industries.(10)  Both Schultz and Sharfstein have noted that the Task Force must identify better methods for explaining the 510(k) process in particular, which could ward off further criticism of the program.(11)

The Task Force plans to hold two public meetings to obtain input from stakeholders, the first of which was held on June 24, 2009.(12)  At this first meeting, FDA specifically sought input on: 1. how the agency can better explain its decisions, processes, and decision-making; 2. what information the agency should provide about its activities in the premarket and postmarket arenas; 3. what tools could be used to effectively provide understandable information about FDA’s activities; 4. what regulatory or legislative changes might be necessary to improve  transparency.(13)  FDA plans to make the transcript of the June 24 meeting available within 30 days of the meeting, at www.regulations.gov.(14)  The Task Force intends to hold the second public meeting in fall 2009, but in the meantime, stakeholders and members of the public can provide feedback via the Task Force website and blog, which are available at: http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm.

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