Drugs

Vanda Sues FDA Over Drug Review Documents

Vanda Pharmaceuticals 4/6 filed a lawsuit in the DC District Court that seeks to compel FDA to produce drug review records under the Freedom of Information Act (FOIA) associated with the company’s supplemental NDA for Hetlioz (tasimelteon) for treating Jet Lag Disorder (JLD) that was given a complete response letter in 2019. Hetlioz is currently approved for Non-24 Sleep-Wake Disorder, a circadian rhythm problem.

In its lawsuit, Vanda complains that the agency has already denied its FOIA request and appeals that sought the review documents. “Not only does Vanda have a legal right to receive copies of the reviews under FOIA’s clear mandate, but providing drug sponsors this information is essential to further scientific inquiry,” the company contends.

“When sponsors, like Vanda here, invest substantial sums investigating new products or new uses for existing products, they must understand the basis for adverse actions taken by FDA,” the company continues. “Disclosure of such information to the sponsor enables the sponsor to determine whether to continue pursuing further development efforts or to abandon the product or indication. Further, providing sponsors this information is necessary to enable a drug sponsor to understand if FDA’s decision-making is accurate… By failing to provide Vanda the reviews, Vanda cannot independently evaluate or verify the conclusions FDA has reached — conclusions which immediately and substantially injure Vanda.”

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