Drugs

DeGette Wants FDA Drug Hoarding Action

Rep. Donna DeGette (D-CO) is asking FDA to act immediately to address the “dangerous hoarding” of hydroxychloroquine and chloroquine. In a 4/8 letter to FDA commissioner Stephen Hahn, she says that tens of thousands of Americans rely on the drugs to treat conditions such as lupus, rheumatoid arthritis, and malaria. She says that patients who need the drugs for FDA-approved uses are facing shortages because President Trump is touting it as a possible Covid-19 treatment.

“While I support continued research to study hydroxychloroquine, chloroquine, and any other drug as a potential treatment to Covid-19,” DeGette wrote, “it is imperative that patients with FDA-approved indications for use are able to get their medications. Their lives depend on it.”

DeGette said FDA should issue a warning to healthcare providers against prescribing hydroxychloroquine and chloroquine for non-FDA-approved uses. She noted that on 3/31 FDA added both drugs to the agency drug shortage list.

She also asked Hahn to detail the steps FDA is taking to ensure that current supplies of the drugs are reserved for patients taking them for FDA-approved uses. And she asked for information on the agency’s plan to address the current hydroxychloroquine shortage and whether supplies of the drugs from the nation’s strategic national stockpile can be used to treat patients with FDA-approved uses in addition to Covid-19.

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