Drugs

Reject FDA Privilege Claim in FOIA Case: WLF

Washington Legal Foundation (WLF) says the DC Circuit federal court should reject an FDA claim of privilege in denying a Freedom of Information Act request. The case involves Vanda Pharmaceuticals’ suit seeking to compel the agency to produce drug review records associated with the company’s sNDA for Hetlioz (tasimelteon) for treating jet lag disorder that received a 2019 complete response letter.

A WLF amicus brief urges the court to grant summary judgment to Vanda’s FOIA request. WLF says that disclosing the reviews would not chill frank discussion within FDA because agency staff have no reason to expect that the documents would be withheld in the first place. FDA routinely discloses medical and statistical reviews when applications are ultimately approved, WLF says, and the reviews become part of the administrative record when a drug sponsor appeals an application’s denial in federal court.

According to the WLF brief, the deliberative-process privilege is the most widely abused FOIA exemption.

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