Biologics

Trump May Not Back New FDA Vaccine Guidance

Just hours after FDA commissioner Stephen Hahn reassured Congress that FDA’s review and approval/authorization of a Covid-19 vaccine will be based on data and science without any political interference, president Trump said new stricter guidance proposed by the agency on the timing of when a vaccine application can be submitted must be approved by the White House. “We may or may not approve it,” Trump told reporters in the press briefing room 9/23. “That sounds like a political move, because when you have Pfizer, Johnson & Johnson, Moderna, these great companies coming up with these — the vaccines, and they’ve done testing and everything else, I’m saying, “Why would they have to be, you know, adding great length to the process?”

Under the proposed guidance (see earlier story), the agency reportedly would ask manufacturers seeking EUA to follow participants in late-stage clinical trials for a median of at least two months starting after they receive a second vaccine shot. And the agency reportedly will also look for at least five severe cases of Covid-19 in the placebo group for each trial, as well as some cases of the disease in older people. The new EUA standards will likely make it next to impossible for a vaccine to be authorized before the election. And once FDA receives a submission, the agency will take weeks and possibly months to review the data, Hahn told a Senate Health Education Labor & Pensions Committee hearing. He offered no additional details on the upcoming guidance.

In a follow-up question, Trump was reminded that the guidance is intended to improve trust in the vaccines and he was asked if he thought that was needed. “Well, I have tremendous trust in these massive companies that are so brilliantly organized, in terms of what they’ve been doing with the tests,” the president responded. “But when they come back, and they say that we have something that works and absolutely works, and they’re coming back with great numbers and statistics and tests and everything else that they have to come back with, I don’t see any reason why it should be delayed further. Because if they delay it a week or two weeks or three weeks, you know, that’s a lot of lives you’re talking about.”

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

Read more

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