FDA Policy/General

Hahn Admits to White House Covid Pressure

In an interview less than 24 hours before he leaves office with the change in presidential administrations, FDA commissioner Stephen Hahn has acknowledged significant pressure from the White House over Covid-19 vaccines and treatments. “I heard loud and clear from the White House, President Donald Trump, and others, that they wanted FDA to move faster,” Hahn told Politico. “With time, particularly over mid- to last summer and then into fall, there was a substantial amount of pressure.”

Hahn said that Trump ran a “results-oriented” administration that sometimes saw a false dichotomy between speed and accuracy in decision-making. He described it as a “clash of cultures that affected many of the conversations.”

In the interview, Hahn also acknowledged the ups and downs in his relationship with outgoing HHS secretary Alex Azar. He was particularly critical of Azar’s decision to establish term limits for dozens of health directors across agencies including CBER director Peter Marks and CDER director Janet Woodcock, who is slated to become acting commissioner under president Joe Biden. He also criticized another last-minute HHS change that FDA believes would strip it of key oversight on genetically modified animals.

Made aware of the change involving the Department of Agriculture following the interview, Hahn tweeted that “FDA does not support the memorandum of understanding and has no intention of abdicating our public health mandate. We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people,” Politico reports.

Because of the objectionable HHS policies, Hahn says a way should be found for FDA to be more independent, although he hasn’t settled on a particular form.

“There’s a lot of different models out there, but I think what we’ve seen over the last year, particularly in the public health emergency, really brings this issue to the fore,” Hahn concluded. “Our rallying cry and our north star have always been science and data.”

Hahn did not say where his career will take him next.

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