Drugs

Vanda Criticizes FDA Over Drug Rejection

Vanda Pharmaceuticals is criticizing FDA for failing to approve the company’s NDA for tradipitant to treat the symptoms of gastroparesis. In 9/2024, FDA issued a complete response letter that the company said was “conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder.”

In a highly critical 1/8 letter to FDA commissioner Robert Califf, Vanda says Califf’s “opacity in decisionmaking and oversight has allowed a culture of obfuscation and closemindedness to fester at FDA. And your agency's review of our application to market tradipitant is no exception.” The company says it responded three months ago to the agency’s concerns in the complete response letter, but nothing has been heard from the agency since to further explain its rejection position.

“This is unacceptable, and stems from the seriously misguided nature of your position that you will not overrule decisions made by civil servants at the agency except in extreme situations such as ‘corruption’ or ‘temporary insanity’ of the decision maker,” the company told Califf. “ As a political appointee and head of the agency, you are the only person accountable to the American public — a public that needs to know that the agency will follow the law and ensure courteous and civil behavior by agency employees.” Additionally, FDA has denied its request to review the NDA in an advisory committee meeting, the letter says.

Vanda acknowledged Califf’s imminent departure due to the new incoming presidential administration and asked Califf to respond before he departs. “FDA's policies, practices, and culture must be evaluated and corrected so as to align with scientific evidence and the law,” the letter said in closing.

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