By Daniel Wilson
Law360, New York (August 07, 2013, 5:44 PM ET) — A California federal judge on Tuesday ordered the U.S. Food and Drug Administration to cough up documents related to the supplemental approval of Gilead Sciences Inc.’s drug Truvada as a HIV preventative treatment, ruling the agency had not justified its refusal to release the information.
According to U.S. District Judge Margaret M. Morrow, the FDA had failed to support its claims that certain documents requested by plaintiff AIDS Healthcare Foundation — a nonprofit which provides medical care to HIV and AIDS sufferers — related to the supplemental approval of Truvada for pre-HIV exposure prophylactic use were blocked from release by exemptions to the Freedom of Information Act suit.
“Accordingly, the court denies the government’s motion for summary judgment as to the documents withheld … and orders the FDA to produce complete and unredacted copies of the [documents] to AHF,” Judge Morrow said.
The agency had argued that Gilead would suffer “substantial competitive harm” if certain Truvada safety and efficacy data is released, meeting the requirements of FOIA’s fourth exemption which blocks the release of trade secrets.
However, as AHF had noted, Gilead has the exclusive rights to the drug and related intellectual property, and Truvada is the only treatment currently approved for preinfection HIV prevention, meaning there was no actual competitive market for directly similar drugs, Judge Morrow found. While the FDA argued that other companies are studying similar drugs, it lacked evidence to show the dangers of this purported future direct competition, the opinion said.
The FDA could have still properly invoked this exemption in relation to the wider anti-HIV drug market — which does involve many more competitors — if it showed competitive harm to Gilead in this context, but it had not provided enough specific evidence to show a likelihood of harm in this wider market, either, according to the ruling.
AHF did not fare as well on its claims for access to documents blocked by the FDA under FOIA’s fifth exemption — which protects privileged inter- and intra-agency documents — however, with the judge ordering an in-camera review of an unredacted version of an email containing background facts and allowing the agency a chance to further justify its decision to withhold certain interpretations of submitted data.
Judge Morrow also found that the FDA had properly refused to release unredacted versions of a number of other documents — for instance, those containing the individual opinions of FDA staff, as well Truvada-related opinions sent to the agency by other federal agencies — saying the documents legitimately fell under a “deliberative process” clause in the exemption.
AHF put a positive spin on the ruling despite failing to win access to all the documents it had sought, saying in a statement Wednesday that the ruling had helped to confirm “one of [its] deepest suspicions” by implying the FDA had worked together with Gilead to help it win approval for preventative use of Truvada in spite of unfavorable trial results.
“Today’s ruling is a huge victory for increased government transparency, and one which will hamper the government’s ability to withhold information about a drug’s safety and efficacy,” AHF President Michael Weinstein said.
The case, filed in September 2011, springs from FOIA requests made by AHF February and March 2011, seeking information on whether on whether Gilead had sought supplemental approval for the use of Truvada as a pre-exposure HIV prevention treatment, as well as any related discussions between the company and the agency.
The FDA denied the requests in July that year, saying releasing such information could cause competitive harm to Gilead, but Gilead subsequently granted a waiver allowing the FDA to reveal its supplemental approval application, resulting in Judge Morrow partially dismissing the suit in February 2012.
The FDA continued to release more documents to the AHF, then moved for summary judgment on the nonprofit’s claims in February, arguing it had conducted an adequate search and had produced all records that AHF was entitled to.
AHF is represented by its attorneys Samantha R. Azulay, Tom Myers and Christina Yang.
The case is AIDS Healthcare Foundation v. U.S. Food and Drug Administration et al., case number 2:11-cv-07925, in the U.S. District Court for the Central District of California.
–Editing by Katherine Rautenberg.