Drugs

Court Orders FDA to Reconsider Vanda sNDA

The U.S. Court of Appeals for the DC Circuit has ruled that FDA improperly rejected Vanda Pharmaceuticals’ request for a hearing on its supplemental NDA that was previously under consideration for sleep drug Hetlioz (tasimelteon) and its proposed use for jet lag

In February, the agency denied a Vanda request for a hearing on its proposed refusal to approve the sNDA for insomnia characterized by difficulties with sleep initiation. The decision, signed by then-acting commissioner and principal deputy commissioner Sara Brenner, said the agency had determined that Vanda “has not stated any genuine and substantial issue of fact that would justify a hearing.”

Brenner said it conclusively appeared from the face of the data, information, and factual analyses that no genuine and substantial issue of fact precluded the refusal to approve. “Vanda’s arguments do not raise any dispute about a material fact, are not supported by specifically identified reliable evidence, are not justified by sufficient data or information, or would not change the outcome if resolved in the way Vanda seeks,” she wrote. “Further, FDA finds that a hearing on the sNDA would not be in the public interest.”

In an 8/15 opinion, the appeals court found that while FDA has discretion to deny NDAs without a hearing when no key facts are disputed, that was not the case in this instance. Vanda had argued that the agency was legally required to hold a hearing before issuing its denial and that the agency’s decision was arbitrary and capricious. The court found that the agency had failed to meaningfully engage with the scientific evidence Vanda submitted and described FDA’s review as “cursory.” The court concluded that the agency must revisit its decision and provide Vanda an evidentiary hearing to resolve outstanding factual disputes.

Vanda first submitted its application in 2018, but the process quickly became mired in legal disputes. A federal district court previously determined that FDA had violated the Food, Drug, and Cosmetic Act by delaying resolution of Vanda’s request for a hearing. Rather than grant a hearing, FDA denied approval outright, prompting Vanda to appeal.

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

Read more

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