FDA Requests Comments on Draft Proposals for FDA Disclosure Policies

Comments are due by July 20, 2010.

(The FDA’s Transparency Initiative was launched in June 2009 to implement the President’s Open Government Directive and is proceeding in three phases: (1) FDA Basics; (2) Public Disclosure; and (3) Transparency to Regulated Industry.

Phase I was unveiled in early January 2010 with the launch of a Web-based resource, www.fda.gov/fdabasics. Phase III will address ways FDA can become more transparent to regulated industry, on which it solicited comments in March 2010. See ITT’s Online Archives or 03/18/10 news, 10031899 #6, for BP summary.)

Draft Proposals on Disclosure in Adverse Reports, Importer Evaluations, Etc.

In its Phase II Transparency Report, the Task Force makes available for public comment 21 draft proposals for changes in policy related to the disclosure of information FDA has in its possession, while supporting the redaction of trade secrets and individually identifiable patient information from all documents proposed for disclosure. The report includes the following draft proposals and topics (partial list):

Adverse event reports. FDA should expand the areas in which it provides online access to public information from adverse event reports about FDA-regulated products, in a format that is searchable and allows users to generate summary reports of this information, including the trade name and/or established name of the product, dosage, route of administration, description of the adverse event, and the health outcome.

Import evaluations. FDA should disclose the outcome of filer evaluations for importers or third parties working on behalf of importers.

Enforcement action. In the weekly FDA publication, “FDA Enforcement Report,” FDA should disclose when the Department of Justice files a case seeking enforcement action on FDA’s behalf in a court of law and the final determination of that case, if known.

Inspections. FDA should 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.

Recalls. When a system is set up that provides FDA with authority to require companies to submit certain information to FDA when they initiate an action to recover or correct a product that is in the chain of distribution, FDA should disclose this information as soon as practicable after receiving this information from the firm.

Docket management. Among other things, FDA should change its current practice so that comments submitted at www.regulations.gov from people self-identified as individual consumers are posted in the same manner as other comments.

(See FDA report for all draft proposals and other topics on which FDA plans to make changes, etc.)

Task Force Will Announce Proposals to be Implemented, Timeframe

After considering public comment on the draft proposals, the Task Force will recommend specific proposals to the FDA Commissioner for consideration, and then FDA will announce which of the proposals it will implement, and the projected timeframe for implementation. FDA notes that some of the draft proposals may require extensive resources to implement, and some may require changes to regulations or legislation.

The Task Force will consider feasibility and priority, considering other agency priorities that require resources, when developing its specific recommendations for the Commissioner.

FDA contact -- Afia Asamoah(301) 796-4625