Drugs

Vanda Hetlioz Dispute with FDA Heats Up

Vanda Pharmaceuticals says FDA commissioner Robert Califf should strike a 9/8 CDER proposed order as being unlawful for several reasons and should then set a prompt deadline for issuing a final decision on whether to grant summary judgment approving a Vanda sNDA for a new Hetlioz (tasimelteon) indication to treat jet lag disorder (see earlier story) or to set a hearing date for the company’s appeal of a denial. In a 9/14 letter, Vanda complains that the new CDER proposed order is untimely in that CDER had issued an order proposing to deny the sNDA and the law and regulations do not permit it to issue a second proposed order, but only to respond to the company’s response.

“CDER’s approach to the summary judgment process was already unlawful for all the reasons we have explained,” the company says, “and this new proposed order only compounds the illegality of this proceeding…. The agency cannot ignore its own regulations … and it therefore cannot consider this new proposed order from CDER.”

Vanda also says the new CDER order is unfair because the time for the Center to iterate on its reasoning is not after the company has made its submissions. “CDER has had years to do that,” it says. “Its attempt to inject material changes to its reasoning at this late juncture is proof positive that its position was never properly justified in the first place and that Vanda is entitled to summary judgment in its favor or at least to expose CDER’s deeply flawed reasoning at a hearing to which it is entitled by statute. By shifting the proposed rationale for denying Vanda relief after Vanda has filed its last submission in this matter, CDER would badly prejudice Vanda. The only proper relief is to strike CDER’s proposed order.”

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