FDA Policy/General

Hahn Said to be On Thin Ice Over Pfizer Vaccine News

FDA commissioner Stephen Hahn reportedly is on thin ice with president Trump and HHS secretary Alex Azar after Pfizer’s announcement Monday of promising Covid-19 vaccine data (see earlier story). The Trump Administration has fired several senior officials at various Departments in the wake of last week’s election for a lack of loyalty, and Hahn had already irked both Trump and Azar earlier over the agency’s expanded requirements for safety information for ongoing vaccine trials that they believed delayed any vaccine from gaining approval before the election. Many FDA watchers are wondering if Hahn’s days are numbered at the agency.

In a fit of rage, Trump called Hahn on Monday screaming in anger about the Pfizer announcement, and calling into question the timing of the announcement shortly after the election, according to a Washington Post 11/11 article. The phone call was followed up by a Trump Twitter post saying the vaccine data should have been announced earlier by FDA, “not for political purposes, but for saving lives! The FDA and the democrats didn’t want to have me get a vaccine win, prior to the election, so instead it came out five days later — As I’ve said all along!”

While the Post notes there is no evidence that Pfizer withheld data or did not report it as soon as it was available, a White House official said without evidence that Pfizer “either knew the data and sat on it, or intentionally did not review it as originally planned, in order to push it beyond the election for political purposes.”

Another White House official told the Post: “Honestly, from my perspective, it’s probably better that we announced anything about the vaccine after the election because it’s going to be more trusted by the American people. I’m not sure Pfizer did the wrong thing.”

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