Phase II Progress Report
FDA issued the Phase II Report, entitled FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration, in May 2010. The Phase II Report made available for public comment 21 draft proposals for changes in policy related to the disclosure of information FDA has in its possession. The proposals support the redaction of trade secrets and individually identifiable patient information from all documents proposed for disclosure. In developing these proposals, the Transparency Task Force weighed the public interest in disclosure against the public interest in confidentiality (including competitive interests). The Transparency Task Force also considered the public comments that it previously received from two public meetings, FDA's online blog, and the Transparency docket.
To develop the broadest slate of draft proposals, the Transparency Task Force, however, did not consider the feasibility of implementing the proposals. In making its final recommendations to the Commissioner, the Transparency Task Force, now, is considering the feasibility of, and the priority of, each draft proposal compared to other Agency priorities that require resources, as well as the public comments that it received. Some of the draft proposals may require extensive resources to implement, and some may require changes to regulations, and possibly even legislation. As a result, the Task Force may ultimately recommend some, but not all, of the draft proposals for implementation.
The Transparency Task Force already has recommended specific proposals to the Commissioner for consideration. The Commissioner has approved some of these proposals, and FDA has begun to implement them. FDA invites the public to track our progress by bookmarking this page. This page will be updated as our efforts progress.
Completed Draft Proposals:
Draft Proposal 2: FDA should change its current practice so that comments submitted at www.regulations.gov from people self-identified as individual consumers are posted on that website in the same manner as other comments. In the Federal Register notice soliciting public comment, FDA should adequately inform commenters about the public disclosure of their comments on www.regulations.gov.
Link: Public Posting and Availability of Consumer Comments Submitted to Food and Drug Administration Dockets
Draft Proposal 4: FDA should post on its Web site all Agency Workplans (i.e., the annual Office of Regulatory Affairs Annual Field Workplans) that are older than five years, starting with the FY 2001 Workplan.
Link: ORA Workplans
Draft Proposal 5: FDA should disclose the outcomes of the filer evaluations for importers or third parties working on behalf of importers. Import Filer Evaluation Outcomes
Draft Proposal 6: FDA should disclose the name and address of the entity inspected, the date(s) of inspection, type(s) of FDA-regulated product involved, and the final inspectional classification—Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI)—for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. The disclosure of this information should be timed so as not to interfere with planned enforcement actions.
Link: Inspections Database
Draft Proposal 7: 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.
Link: Inspection Observations
DRAFT PROPOSAL 19: If FDA is aware of confusion in the marketplace about products that may be implicated in a food outbreak, and information gathered by industry or other sources may serve to alleviate that confusion, FDA should support efforts by industry and others to communicate information to the public about products that are not subject to the recall when sufficiently reliable information about products not connected with the recall exist, if FDA concludes that disclosure of this information is in the interest of public health.
Link: Assisting Interested Parties in Addressing Marketplace Confusion Over the Identity of Products Subject to Recall
DRAFT PROPOSAL 21: In accordance with Draft Proposal 21, FDA is expanding its posting of untitled letters on the Internet.
Link: Warning and Untitled Letters