Bloomberg Law
Oct. 7, 2020, 12:42 AM

FDA Redactions Upheld in FOIA Suit for Drug Approval Documents

Maeve Allsup
Maeve Allsup
Legal Reporter

The Food and Drug Administration correctly redacted documents regarding the approval of a drug, based on a Supreme Court ruling on the application of the Freedom of Information Act, a federal judge in New York said Tuesday.

Charles Seife, a science writer and journalism professor sued the agency under FOIA in the U.S. District Court for the Southern District of New York, seeking records related to the accelerated approval of eteplirsen, a drug created by Sarepta Therapeutics Inc. for the treatment of a rare neuromuscular disease.

The decision to grant the drug accelerated approval was controversial, because while the FDA’s ...

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