Drugs

Withdraw Insulin Reimportation Proposal Request: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to withdraw its 9/24/20 Request for Proposals (RFP) Regarding Insulin Reimportation Programs. A 12/17/20 petition also calls on the agency to:

refrain from reimportation of insulin under section 801(d)(2) of the Federal Food, Drug, and Cosmetic Act unless insulin is in shortage as a result of a medical emergency;
establish a process by which the drug manufacturer has notice and an opportunity to participate in the decision-making process for an application for reimportation of its drug product under section 801(d)(2); and
provide the public with notice whenever an application for drug reimportation under section 801(d)(2) has been approved.

The petition says FDA’s Request for Proposals “ignores significant risks to patient safety posed by imported insulin and failed to consider the factors FDA itself has identified as relevant to determining whether a drug is ‘required for emergency medical care.’” The petition also says FDA is relying on an improper reading of section 801(d)(2) and the RFP is “plagued by additional legal flaws.”

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