Journalist Charles Seifi on Thursday filed a federal lawsuit against the Food and Drug Administration over the withholding of documents surrounding the controversial approval of Exondys 51, a Duchenne muscular dystrophy drug, reports Boston Business Journal.
Here are four things to know.
1. The FDA approved Exondys 51 — developed by Sarepta Therapeutics — last September. While FDA staff who reviewed the drug's application opposed approval saying there was no proof of the drug's efficacy, an FDA director overruled the group and approved the drug. Analysts suggested the move could set a dangerous precedent by dropping the standard level of efficacy required for a drug's approval, and critics questioned whether emotions tied to patient advocacy efforts affected the agency's decision.
2. Mr. Seife, who also teaches at New York City-based NYU, in December requested FDA records pertaining to the drug's approval under the Freedom of Information Act, including emails sent between high-ranking FDA officials about Exondys 51, reports Boston Business Journal.
3. The lawsuit alleges the agency unnecessarily delayed responding to Mr. Seife before denying his request. Since Exondys 51 costs $300,000 annually — and many insurers are hesitant to cover it — the lawsuit argues releasing the documents is in the best interest of the public, according to the report.
"It will shed light on the hotly debated issue of whether the FDA approved an entirely ineffective drug based on faulty clinical trials and undue industry influence, or whether an effective drug is being unjustly excluded from reimbursement in many prescription drug plans," the lawsuit reads.
4. An FDA spokeswoman told Boston Business Journal the agency "does not comment on pending or ongoing litigation."
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