Drugs

CDER Cleaning House on Dormant Petitions

CDER appears to be clearing its deck of unresolved citizen petitions that have lingered for more than five years at the agency without producing formal responses. In a letter to petition holder BakerHostetler, the Center it has been reviewing unresolved petitions assisgvpned to for action. “One goal of this review is to identify citizen petitions submitted more than five years ago that petitioners may believe are no longer timely. CDER believes that having to respond to these old petitions diminishes the Center’s capacity to address in a timely fashion pressing public health issues. Therefore, these petitions have a lower priority, and it is unlikely that the Center will have the resources to respond to them soon.”

In BakerHostetler’s case, the initial petition was submitted more than eight years ago and it asked FDA to declare that NDA 17-351 for Alaven Pharmaceutical’s Cortifoam (hydrocortisone acetate rectal aerosol) was not approved and the drug is not being marketed in accordance with the Federal Food, Drug, and Cosmetic Act. The petition said that the law’s requirements for substantial evidence of efficacy and for adequate tests of safety were not and never have been satisfied for the NDA.

“Lacking evidence of efficacy and safety, the Cortifoam label does not provide physicians information adequate to make an appropriate risk/benefit judgment when deciding whether to prescribe Cortifoam,” the petition declared. “Consequently, approval of NDA 17-351 should be withdrawn and Cortifoam should be withdrawn from the market.”

FDA says that because of how long the petition has sat inactive at the agency, it is “uncertain as to whether the views and requested action presented in the petition reflect your current views.” The agency says BakerHostetler has 30 days to decide and notify it that the petition should remain active. Otherwise, FDA will declare the petition to have been voluntarily withdrawn.

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