Sponsors developing drugs in competitive spaces may find themselves in a confidentiality pickle if a federal court ruling on what information the FDA must release under a Freedom of Information Act (FOIA) request is allowed to stand.
The U.S. District Court for Central California last week ordered the FDA to release complete and unredacted safety and efficacy summaries and other documents pertaining to the development and review of Gilead Sciences Inc.'s application for Truvada as an HIV pre-exposure prophylaxis.
The suit was filed by the AIDS Healthcare Foundation (AHF) after it was denied FOIA requests for the documents, which it claimed confirmed that the FDA "colluded with Gilead to fast-track approval of Truvada as PrEP regardless of the results of clinical trials."
What is at stake in the ruling is the confidentiality sponsors expect in their discussions with FDA staff about the development of their drugs. Such meetings and correspondence are a vital part of the drug development process – so much so that they are included in the FDA's performance goals under PDUFA.
Some documents included in the ruling involve correspondence memorializing discussions between the drugmaker and FDA staff about other studies conducted with Truvada that contained unfavorable results and what datasets Gilead would submit in support of the proposed indication. Disclosing those discussions would enable competitors to see how challenging PrEP study results could be successfully addressed, David Pizzuti, Gilead's vice president of regulatory affairs, said in his testimony. Read more
