Public Citizen v. Food and Drug Administration and Department of Health and Human Services
- Plaintiff’s Reply to Motion for Summary Judgment (08/04/2016)
- Carome Declaration and Exhibits (07/11/2016)
- Clattenburg Declaration and Exhibits 1-8 (07/11/2016)
- Exhibits 13-15 (07/11/2016)
- Exhibits 16-21 (07/11/2016)
- Exhibits 22-24 (07/11/2016)
- Exhibits 25-32 (07/11/2016)
- Exhibits 33-37 (07/11/2016)
- Exhibits 38-40 (07/11/2016)
- Exhibits 41-42 (07/11/2016)
- Exhibits 9-12 (07/11/2016)
- Plaintiff’s Motion for Summary Judgment (07/11/2016)
- Plaintiff’s Opposition to Motion to Dismiss (07/05/2016)
- Complaint (04/27/2016)
Advisory committees furnish expert advice to federal government agencies. The FDA has approximately 50 advisory committees and panels that advise the agency on issues related to FDA-regulated products, such as whether the FDA should approve new medical products, request additional studies, or change a product’s labeling. The FDA posts on its website a roster of the members serving on each advisory committee, frequently accompanied by members’ curricula vitae (CV). The FDA frequently redacts the CVs, however, by blacking out information about the dates of degrees conferred, the names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of unpublished articles.
Believing that the redactions based on the FDA’s determination that the information is “confidential” or “private” are unjustified under FOIA and that the information redacted would help the public better to assess the backgrounds, qualifications, and potential biases of advisory committee members, Public Citizen submitted a FOIA request to the FDA in May 2014, in which Public Citizen requested “unredacted” copies of the CVs. As of April 2016, only three of the FDA’s six divisions had responded to the request, and all but one continued to redact information from the CVs.
Public Citizen sued the FDA under FOIA seeking an order compelling the FDA to respond fully to its request, without the redactions that appear to be wholly unjustified.The lawsuit also suit seeks an order requiring the FDA to post unredacted copies of the CVs on its website going forward.
In January 2017, Public Citizen and FDA entered into a settlement agreement requiring FDA to post unredacted advisory committee member CVs on its website. The new policy calls for advisory committee members and applicants to submit a form authorizing FDA to publicly post their CVs online and for FDA to cease removing or redacting any information from the CVs of committee members. The case is stayed while FDA implements the new policy.