Drugs

Virtus Pharmaceuticals Petition Denied on Procedural Grounds

FDA has denied on two procedural grounds a Virtus Pharmaceuticals 7/11 petition that presented information alleging that Lehigh Valley Technologies, Pharma Research Software Solutions (PRSS), and Pharma-Med, Inc. inappropriately avoided paying user fees for two NDAs. The petition asked the agency to:

institute proceedings to remove the relevant NDAs for potassium chloride for oral solution sponsored by PRSS and potassium chloride oral solution sponsored by Pharma-Med, for inappropriately avoiding paying user fees of $2.3 million; and
investigate the matter in accordance with the FDA application integrity policy and not take action against other potassium chloride oral solution drug products until the matter has been resolved.

The agency response says it is denying the petition to the extent that it requests that FDA address through the citizen petition process whether a user fee waiver was obtained inappropriately. The letter says that agency staff would have to engage in a process of fact gathering and further inquiry that could potentially require analysis of financial or other information to which disclosure restrictions may apply.

It also says that to the extent that the petition asks FDA to refrain from taking enforcement action against potassium chloride oral solution products, such requests are not properly the subject of a citizen petition.

“We nevertheless appreciate the information you provided, and we take the issues you raise seriously,” FDA says in the letter. “We will evaluate this matter to determine whether follow-up action is appropriate. Please note that your petition is being denied solely on procedural grounds and that this response does not represent a decision by the agency to take or refrain from taking any action relating to the subject matter of your petition.”

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