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FDA Releases Draft Proposals on Public Disclosure Policies

Jun 4, 2010

The Food and Drug Administration (FDA) requested public comments on 21 draft policies that would expand disclosure of information by the agency while protecting industry trade secrets. The publications of the draft policies are part of the second phase of a three phase Transparency Initiative started in January 2009 by President Obama's memorandum to all agencies on Transparency and Open Government. (For more information, see the PackagingLaw.com article, FDA Forms Transparency Taskforce.)

The 21 draft policies were developed after FDA's Transparency Task Force reviewed more than 1,500 comments received during Phase I of the initiative. They can be found in the report, "FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration," which was published May 19, 2010. Phase III of the initiative will consist of issuing draft proposals via the notice and comment rulemaking process.

Among the proposed policies are two that would increase public access to FDA inspection reports. The agency currently only posts inspection reports when either a high level of public interest is anticipated or the reports are "frequently requested." FDA suggested in the report that public disclosure of some inspection information may make firms accountable to the agency and the public at large, as well as provide an incentive to correct violations. Therefore, the agency recommended that the name and address of an inspected facility, along with the date(s) of inspection, type(s) of FDA-regulated product involved, and the final inspectional classification be publically disclosed, but that the disclosure should be timed so that it does not interfere with planned enforcement actions. Another draft policy proposal calls for FDA to "generate, and share with the public, information about the most common inspectional observations of objectionable conditions or practices that are made during inspections of FDA-regulated establishments and post that information online on a regular basis."

FDA noted in the report that there are gaps in its current recall communication policies. As a result, FDA proposed that manufacturers and distributors be required to inform the agency when they initiate a recall. Additionally, FDA recommended that the agency should inform the public when it determines that a recall is terminated, and that FDA should support efforts by industry and others to inform the public about products not subject a recall when there is confusion in the marketplace.

Other draft policies would expand public access to information from adverse event reports about FDA-regulated products and warning letters issued by the agency. FDA also recommended posting comments by "individual consumers" on www.regulations.gov . Comments on the draft policies are due by July, 20, 2010.