Late last week, the US Food and Drug Administration’s Transparency Task Force published a series of proposals about public disclosure policies. The 21 proposals are part of the agency’s transparency initiative, which was launched last summer, and are aimed at helping industry and the public better understand how the agency works. FDA will consider public comments—due July 20, 2010—before moving forward with final proposals.
“Our goal is to facilitate transparency that promotes public health and innovation,” said Joshua Sharfstein, FDA principal deputy commissioner and chair of the Transparency Task Force, in a release about the announcement. “These proposals reflect a careful balancing of the importance of transparency with the importance of protecting trade secrets and confidentiality.”
The draft proposals focus on proposed 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,” according to the Federal Register announcement.
The draft proposals report begins with this 1978 quote from then-FDA Commissioner Donald Kennedy: “…people affected by governmental decisions have a right to know the basis on which they are made.” Below are some of the key proposal topics:
• Adverse events: FDA proposes expanding public online access to information about adverse-event reports, including the health outcome of the patient affected, to the extent of being able to search for and generate summary reports on a series of adverse events.
• Inspections: FDA proposes the disclosure of the name and address of entities inspected, including dates, products involved, and results.
• Applications: FDA proposes the disclosure of existing—or nonexisting—investigational applications, new drug applications, abbreviated new drug applications, biologic license applications, orphan drug designation applications, and more. Also disclosed would be the application’s status and the agency’s response to the application.
A full background and explanation for each draft proposal is included in the Transparency Task Force report.
The proposals are based on some 1500 comments received in 2009, including remarks made at two public task force meetings and comments on the agency’s transparency blog. The blog, along with the agency’s new FDA Basics mini website are part of the task force’s first phase of the transparency initiative. The public-disclosure proposals represent the second phase. Phase three will focus on ways FDA can improve transparency with the regulated industry—proposals should be released this summer based on comments that were due in April.