Drugs

FDA Wins FOIA Ruling on ‘Confidential Info’ Redactions

A 10/6 New York Southern District ruling in a Freedom of Information Act (FOIA) lawsuit found that FDA appropriately allowed company-directed redactions of commercial confidential information contained in Sarepta’s NDA for Duchenne multiple sclerosis drug Exondys 51 (eteplirsen). The lawsuit by New York University journalism professor Charles Seife, who has written that it’s impossible to trust FDA decisions and statements because the agency “worries more about a drug’s side effect on a company than on a patient.” It was filed after FDA denied access to information about eteplirsen, which he described as censoring side effects, outcome measures, and even possible evidence of misconduct. His original FOIA request was intended to better understand the eteplirsen approval decision in which CDER director Janet Woodcock overruled agency medical reviewers (see earlier story) and approved the drug for marketing.

Seife’s primary argument was that the information requested is not confidential because Sarepta publicized it when submitting an application to the European Medicines Agency (EMA) knowing that the EMA would publish the submitted data when a decision was made. “But while the EMA did publish an assessment report of the drug when it later denied Sarepta's application, Seife provides no evidence that the report contains information identical to the withholdings at issue,” the ruling said. “In the alternative, Seife contends that Sarepta publicly shared the information at issue when it collaborated with third parties. But ‘[t]hese types of limited disclosures,’ subject to nondisclosure agreements and ‘not made to the general public,’ do not preclude Exemption 4 protection,” it said. The court further said that Seife offered “nothing to undermine the conclusion, based on declarations from those with firsthand knowledge of Sarepta's actual practices, that Sarepta has consistently maintained the confidentiality of the information.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome