FDA task force proposes 21 transparency initiatives

Adverse event reports and recall information for food, drugs and medical devices would be made available online

The Food and Drug Administration is considering whether to release reports online about adverse events involving foods, drugs or medical devices, as well as 20 other new transparency initiatives to improve the agency's disclosures to the public and to industry.

The FDA’s Transparency Task Force, composed of senior FDA officials, released the draft proposals for public comment on May 19 on the agency's Web site. The goal is to increase the amount of FDA information discloses to the public while also honoring protections against release of trade secrets and personal identifiable information, the notice said.

The task force wants to hear from the public within 60 days on which proposals should be a priority, and which are most feasible, in additional to general comments on the content of the proposals.

Based on the input received, the task force will recommend specific proposals to the FDA commissioner.

“The Task Force’s recommendations will consider feasibility and priority, considering other agency priorities that require resources,” the notice states. “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 21 draft proposals cover a broad range of FDA information, including releasing more information on new drug investigations, publishing of individual consumer comments on FDA proposed rules, and increasing online information available on adverse event reporting and product recalls.

For the adverse event reports, the FDA would expand its online public access to the reports, in a format that is searchable and allows users to generate summary reports.

About the Author

Alice Lipowicz is a staff writer covering government 2.0, homeland security and other IT policies for Federal Computer Week.

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