Drugs

Ex-FDA Commissioners Urge Coordinated Covid-19 Plasma Effort

Four former FDA commissioners are urging U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect blood plasma and begin clinical trials to determine whether the plasma from recovered patients can help those who become sick. Writing in a Washington Post opinion piece, Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb support a coordinated group called “The Fight Is In Us” to demonstrate that such a therapy is safe and effective. They describe the group as a “broad coalition of medical and research institutions, blood centers, life science and technology companies, philanthropic organizations and covid-19 survivor groups” who are working to drive awareness and recruit plasma donors across the country.

The former commissioners use the confusion surrounding hydroxychloroquine to illustrate why randomized trials are quickly needed to determine if convalescent plasma’s benefits outweigh its risks in Covid-19 patients. “Thousands of covid-19 patients have been treated with plasma, but we are not much closer to definitively answering those questions,” they contend. “Its use makes common sense, and preliminary studies are promising, but we won’t know how to best use convalescent plasma products until we complete randomized clinical trials in which some people are treated and others receive usual care.”

“Given the urgency of the covid-19 crisis,” the former officials write, “we need to create new pathways for quickly advancing promising therapies while clearly determining whether they’re safe and effective. We can’t waste precious time and put people at risk by treating them with therapies that don’t work or miss opportunities to collect data and determine when a treatment is beneficial.”

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