Drugs

Act on Cancer Chemo Shortages: Michigan Reps

The 13 House members from Michigan have sent a bipartisan letter to FDA commissioner Robert Califf urging the agency to take immediate action to mitigate the effects of a nationwide shortage of chemotherapy drugs. Led by Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI), the delegation letter says multiple hospitals in the state are experiencing shortages, according to a statement (includes a link to the letter) from Dingell.

“These chemotherapy shortages come amid a shortage of other critical cancer medications,” the letter says. “Taken together, they are straining the ability of doctors to provide the best course of treatment for their patients. We are hearing directly from impacted hospitals urging immediate action to address these alarming challenges.”

The legislators say they understand the shortages have been fueled, in part, by a halt in production at India’s Intas Pharmaceuticals after an inspection found quality control violations. “We appreciate the robust oversight FDA conducts to ensure medications from overseas facilities are held to high quality standards,” the letter says, “but more must be done to ease the troubling supply disruptions that put patients at risk.”

The representatives ask for an immediate FDA briefing and answers to these questions:

how FDA is working with manufacturers to mitigate the shortage of cisplatin, carboplatin, and methotrexate;
whether additional shortages of other chemotherapy drugs should be expected;
what flexibilities FDA can provide to help manufacturers swiftly increase their production of the three drugs;
when FDA expects the chemotherapy drug shortage to alleviate; and
how the agency is leveraging temporary importation and other flexibilities to work with the industry on bringing other manufacturers into the market to alleviate the shortages of the three drugs.

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