Drugs

White House Credits FDA on Drug Shortages

A 9/12 White House statement discusses steps taken by FDA to address cancer drug supply issues and prevent impacts to patients. The statement identifies these FDA actions:

for generic carboplatin and cisplatin, the agency worked closely with cancer drug manufacturers to help identify opportunities to increase manufacturing capacity and bring companies that had stopped producing these drugs back to the U.S. market;
FDA exercised enforcement discretion for a manufacturer to import 14 lots of cisplatin from an FDA-registered facility outside of the U.S.;
the agency worked closely with the five manufacturers of generic methotrexate for injection to help increase supplies during the drug shortage; and
close cooperation among FDA, the manufacturers, and healthcare systems is helping to ensure about 400,000 patients per month receive their treatments.

The statement says that shortages have not been fully resolved and that FDA continues to work with drug manufacturers and healthcare providers to help restore access to essential cancer treatments and other medicines that are currently in short supply.

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