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Thursday, August 10, 2017
MFIA/CRIT Lawsuit Prompts Expedited Release of Information from FDA
In response to a lawsuit filed by Yale Law School’s Media Freedom and Information Access Clinic (MFIA) and supported by the Collaboration for Research Integrity and Transparency (CRIT), the Food and Drug Administration (FDA) granted expedited processing to a Freedom of Information Act (FOIA) request for information concerning one of the most controversial drug approvals in FDA history and the contested clinical trials supporting it. Acting under court order, the FDA released an initial set of documents on July 24, 2017 with additional documents scheduled for rolling production starting August 17, 2017. Those working on the case from Yale Law School said the development is significant because the FDA’s FOIA office has been known to delay complex FOIA requests with significant public health consequences sometimes for years and because it reinforces a critical principle—that transparency is key to the integrity of the clinical trial process.
The FOIA request had been submitted late last year by public health journalist Charles Seife seeking information about the FDA’s approval of Exondys 51, used to treat the rare and fatal childhood illness Duchenne Muscular Dystrophy. The drug costs at least $300,000 per year, and usually substantially more. Serious questions surrounding the FDA’s approval of the new drug surfaced quickly, and Seife’s sources contend that the FDA bent its safety and efficacy standards in response to patient pressure and lobbying from the drug’s manufacturer, Sarepta Therapeutics. Questions have been raised by current and former FDA officials about the clinical trials on which the FDA approval was based, which involved a very small number of patients, inconsistently used a comparison group, and relied on a marginal increase in the level of a certain protein to demonstrate an effect of the drug rather than an actual clinical benefit to patients’ health.
After Seife’s request for expedited release of materials concerning the approval was denied by the FDA, he filed suit in federal court in New York. According to David Schulz, Co-Director of MFIA, “the prompt of information concerning Exondys 51 is significant because the FDA rarely agrees to expedite processing of FOIA requests.” Indeed, the most recent information on the FDA’s website shows that in fiscal years 2014 and 2015 the FDA expedited only one FOIA request out of the 822 submitted. In addition, the two expedited requests actually processed during this time took 693 and 862 days, respectively, to complete. MFIA supervising attorney and staff attorney at CRIT who litigated the case, Cortelyou Kenney, explained that these delays “blatantly violate the statutory obligation in FOIA to issue a decision within ten days whether to release the requested information where a compelling need for the information exists or where the agency determines it should release the information in an exercise of its discretion.”
Seife’s victory in obtaining release of the Exondys 51 information is also significant for the Duchenne community and sheds new light on the FDA’s deliberations and how it responds to pressure from manufacturers and patient groups. Information released on July 24 describes apparent violations of FDA regulations during the approval of Exondys 51, including off-the-record meetings held with representatives of Sarepta. Shining a light on the FDA’s actions will help promote accountability in ensuring the drug approvals are based on sound science rather than pressure from industry or possible distortions in data, those working on the case said. The remaining information, which includes the scheduled release of Clinical Study Reports (key scientific documents for drug approvals) may also help show whether the drug works. According to the lawsuit, release of these documents could significantly affect the wellbeing of patients, whose families are spending enormous sums of money to obtain a drug not covered by many insurance companies and that according to some within the FDA may be no better than an “elegant placebo,” which carries risks of infection and even death.
The Media Freedom and Information Access Clinic (MFIA) is a law student clinic at Yale Law School dedicated to increasing government transparency, defending the essential work of news gatherers, and protecting freedom of expression by providing pro bono legal services, pursuing impact litigation, and developing policy initiatives. MFIA is a program of the Abrams Institute for Freedom of Expression at Yale Law School.
The Collaboration for Research Integrity and Transparency (CRIT) is an inter-disciplinary initiative launched in 2016 at Yale Law School, Yale School of Medicine, and Yale School of Public Health, whose mission is to promote health by improving the integrity and transparency of biomedical and clinical research.
Cortelyou C. Kenney