Legal News

FDA Plans Greater Public Transparency

Food and Drug Safety Goes See-Through?

This week, the U.S. Food and Drug Administration (FDA) announced the formation of a new task force that will examine the agency's policies and practices when it comes to making information public. The task force will make recommendations on how the FDA can improve the transparency of its operations and decision-making processes.

What sorts of changes can consumers expect through the FDA's new looking glass? Here's a look at some highlights of the FDA Transparency Task Force's plan:

• Identify what agency information and actions should be opened up to the public, and what needs to remain confidential.
• Explore ways the agency can better explain its operations to the public, including specific enforcement actions and and product approvals.
• Eliminate the barriers (internal and external) to providing useful and understandable FDA decision-making information to the public.
• Improve current FDA policies to better provide timely information to the public, including the identification of new tools and technological avenues that can be utilized to provide updates on FDA actions, both pending and in progress.
• Recommend legislative or regulatory actions that can improve the FDA?s ability to provide information to the public.

On the heels of the announcement of the new FDA Transparency Task Force, the FDA also scheduled a June 24 public meeting to hear recommendations on how the agency can better provide "useful and understandable information on its activities and decisions," according to the FDA News Release.

The Wall Street Journal reports that the new task force will seek to combat the FDA's reputation as a "black box that makes important decisions without explaining them," as FDA Commissioner Margaret Hamburg put it." Topics likely to be on the table include clinical-trial data and details on decisions about recalls and drug approvals," according to the WSJ. 

• News Release: FDA Forms Transparency Task Force (FDA.gov)
• FDA Transparency Task Force (FDA.gov)
• Wall Street Journal Health Blog: FDA Tries to Decide What Should, Shouldn't Be Kept Secret
• N.Y. Times Editorial: FDA's Secret Files
• Legal Questions and Answers (provided by Law Offices of Jack Bloxham)
• Products and Legal Issues (provided by Bernard & Stuczynski)  

Full post as published by FindLaw's Common Law on June 03, 2009 (boomark / email).