Drugs

PhRMA, Others Petition Against Drug Importation

A citizen petition from Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines, and Council for Affordable Health Coverage asks FDA to not approve a proposal from Colorado’s Department of Health Care Policy & Financing that seeks to import drugs from Canada.

The petition says the proposal was submitted under a program authorized by then-president Trump’s HHS secretary, Alex Azar. It says the program’s final rule “conflicts with the FDCA and is in excess of statutory authority in key respects… Drugs imported under the final rule would necessarily be unapproved new drugs and misbranded drugs, neither of which can legally be imported into the United States.”

Additionally, the petition notes that under the agency’s approval process, FDA reviews everything about the drug, including its “composition, the method of its manufacture, its packaging, and its labeling.” But under the proposal, drugs imported would “differ from drugs approved in the respective applications,” it says. The petition also contends that attaching FDA-approved labeling to the imported drugs as the rule requires would misbrand them.

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