Court's FOIA Ruling Could Endanger Trade Secrets
By Mari Serebrov
Sponsors developing drugs in competitive spaces may find themselves between a rock and a hard spot going forward 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 (emtricitabine/tenofovir disoproxil) as an HIV pre-exposure prophylaxis (PrEP).
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.
In discussions with sponsors, the FDA may advise on trial design, endpoints, enrollment criteria, fast-track, accelerated approval, etc. It also becomes privy to confidential, proprietary information.
"We really have to hope that FDA appeals. . . . This is a threat," said Steven Grossman, president of HPS Group LLC and a former deputy assistant secretary at the Department of Health and Human Services. "FDA can't afford for district court judges to undercut the FOIA protection as FDA has laid it out."
(Saying it doesn't comment on litigation, the FDA wouldn't indicate whether it is considering an appeal.)
Some of the documents at issue in AIDS Healthcare Foundation v. FDA are Gilead's summaries and analyses of raw data and reports that reveal the Foster City, Calif.-based biotech's efforts to develop statistical methods to transform the data gathered by third-party researchers into a format acceptable to the FDA.
In seeking to have the suit dismissed, the FDA contended that public disclosure of Gilead's statistical methods and analyses would allow its competitors to use the same techniques and methodologies to obtain approval.
Some documents at stake 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.
Government agencies usually win FOIA cases based on competitive harm, Grossman told BioWorld Today, because of the "larger public policy interest in protecting trade secrets and proprietary information." Courts generally recognize that "the burden ought to be very high to break" that FOIA exemption, he added.
But Judge Margaret Morrow denied the FDA's motion for summary judgment, severely restricting the competitive exemption. To deny an FOIA under Exemption 4, "an agency must present specific evidence revealing actual competition to establish competitive harm," she said. Simply claiming the HIV market is extremely competitive isn't enough.
The judge also drew a line between the HIV market as a whole and the PrEP market, noting that no other drugs have been approved for PrEP and no such drugs appear to be in clinical trials. While Truvada may face competition in HIV, it has no competition in PrEP.
In coming to that conclusion, she disregarded testimony from the FDA and Pizzuti that there will be competition in the space in the future. "Although Pizzuti asserts, 'on information and belief,' that other companies are working to develop drugs that 'would be in direct competition with Truvada's FDA approved indication for PrEP,' there is no foundation for this testimony," the judge wrote.
"Pizzuti does not state that he has personal knowledge of the drug development efforts of companies other than his, or that his assertion rests on other reliable sources of information," she continued. "A declaration used to support a motion for summary judgment must be based on personal knowledge."
While the court decision focuses on what is and isn't exempt from FOIA requests on both competitive harm and agency working document grounds, AHF is using its victory to push for more distance between the FDA and drugmakers.
"The FDA is supposed to act as a neutral entity. . . . The lack of neutrality shown by the FDA here is breathtaking further underscored in recent years by the fact that the FDA's budget for drug approval is now directly paid for by pharmaceutical companies such as Gilead," said Tom Myers, AHF's general counsel and chief of public affairs.
For groups like AHF, "the mere fact of [a sponsor] meeting with FDA is damning," Grossman said.
Despite the ruling and the AHF's views on sponsor meetings with the FDA, drugmakers must continue to have meetings with the FDA on fundamental issues involving the development of their products.
They "don't really have a choice," Grossman said. They have to talk with the FDA, and they need the agency's feedback.
But at the same time, sponsors will need to think about their vulnerability in the likelihood of an FOIA suit like this one. "People should be nervous," Grossman said.
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