Biologics

FDA Not Cutting Vaccine Standards: Companies

Executives from five drug companies told a House Energy and Commerce subcommittee that FDA is not easing regulatory standards for Covid-19 vaccines despite the pressure to get one or more approved quickly. The Hill reports that testifying were executives from Moderna, Janssen, Merck, AstraZeneca, and Pfizer.

“We do believe it’s possible to develop a safe and effective vaccine,” said Janssen head of clinical development Macaya Douoguih. “A lot needs to be done in parallel, but it can be done safely and without compromising any of the standards we usually undertake for any clinical trial.”

Rep. Frank Pallone (D-NJ) expressed concern that President Trump would pressure FDA to lower its standards. The agency has released guidance outlining conditions for approving a Covid-19 vaccine, including that it must be at least 50% more effective than a placebo in preventing the disease.

AstraZeneca executive vice president Mene Pangalos said it is understandable that people may have questions about whether the companies are cutting corners. “Despite the speed we are working at, we are neither cutting corners and regulators are not lowering their standards,” he said. “So I feel comfortable that if there are vaccines that are effective, they will be safe and effective, and it’ll be good to go in terms of getting regulatory approval.”

Concern also was expressed about deployment of any approved vaccine when the company officials said they planned to rely on the federal government for distribution. “All of you are relying on a government that couldn’t procure proper personal protective equipment for wide swaths of the population,” said Rep. Joe Kennedy (D-MA). “That’s great, you’re saying you’re relying on the federal government…. Clearly, the federal government has failed here multiple times over. The consequence of not doing this right is going to be dramatic.”

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