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.

FCW in Print

In the latest issue: Looking back on three decades of big stories in federal IT.

Featured

  • FCW @ 30 GPS

    FCW @ 30

    Since 1996, FCW has covered it all -- the major contracts, the disruptive technologies, the picayune scandals and the many, many people who make federal IT function. Here's a look back at six of the most significant stories.

  • Shutterstock image.

    A 'minibus' appropriations package could be in the cards

    A short-term funding bill is expected by Sept. 30 to keep the federal government operating through early December, but after that the options get more complicated.

  • Defense Secretary Ash Carter speaks at the TechCrunch Disrupt conference in San Francisco

    DOD launches new tech hub in Austin

    The DOD is opening a new Defense Innovation Unit Experimental office in Austin, Texas, while Congress debates legislation that could defund DIUx.

  • Shutterstock image.

    Merged IT modernization bill punts on funding

    A House panel approved a new IT modernization bill that appears poised to pass, but key funding questions are left for appropriators.

  • General Frost

    Army wants cyber capability everywhere

    The Army's cyber director said cyber, electronic warfare and information operations must be integrated into warfighters' doctrine and training.

  • Rising Star 2013

    Meet the 2016 Rising Stars

    FCW honors 30 early-career leaders in federal IT.

Reader comments

Please post your comments here. Comments are moderated, so they may not appear immediately after submitting. We will not post comments that we consider abusive or off-topic.

Please type the letters/numbers you see above

More from 1105 Public Sector Media Group