ARTICLE | Company News

Gilead, AIDS Healthcare Foundation (AHF), U.S. Food and Drug Administration infectious news

February 24, 2014 8:00 AM UTC

The U.S. District Court for the Central District of California ordered FDA to provide additional records to the AHF related to the pre-exposure prophylaxis (PrEP) use of Gilead's HIV drug Truvada emtricitabine/tenofovir. AHF filed suit against FDA in 2011 alleging the agency improperly withheld information on its review of Truvada for PrEP that the foundation had requested under the Freedom of Information Act (FOIA).

In August, the district court ordered FDA to produce complete safety and efficacy records for Truvada in the indication. The court said the data were not exempt from disclosure under FOIA as trade secrets because FDA did not show Gilead faced competition in the PrEP market. At the time, the court said it did not have enough information to determine whether FDA properly withheld data summaries and meeting minutes. In its latest ruling, the court ruled that because FDA had disclosed data interpretation documents to Gilead, the documents were not exempt from FOIA as inter-agency or intra-agency memos or letters. The court thus ordered FDA to provide data interpretation records, emails and meeting minutes to the foundation. The court did say FDA could withhold patient identification. Under FOIA, information in individual "personnel and medical files" are exempt from disclosure (see BioCentury, Aug. 19, 2013). ...