FDA Policy/General

‘FDA Represents Science in Action’: Hahn

Taking advantage of a supportive audience at the Reagan Udall Foundation 10/13 annual meeting, FDA commissioner Stephen Hahn again reiterated the agency’s science-based decisions and avoidance of political pressure. “Of course, our work on Covid-19 and non-Covid issues comes with unprecedented public scrutiny,” Hahn said. “And sometimes criticism. Any agency that has the broad responsibilities and impact of FDA, particularly involving issues of public health, can’t expect to do its job without inviting controversy and disagreement.”

The commissioner said it is essential that the criticism directed at FDA never shakes the underlying faith the public has and should have in the agency and its commitment to protecting public health.

“I am confident in the decisions that are being made related to Covid-19 and that will be made as we continue to address these challenges,” Hahn said. “I know there has been particular attention paid to a few of the decisions reached by FDA scientists over the past several months. I want to assure you that every one of them has been made by career FDA scientists based on science and data, not by politics.”

He described the agency’s work as “science in action” and pointed out that its scientists often must make real-time decisions based on ever-evolving data concerning a previously unknown, highly contagious virus that experts are still learning about. He said it is sometimes necessary to change or reverse direction as new data emerge.

In his report, Hahn reviews work done by the agency’s Centers in FY 2020, drawing attention particularly to successes in food safety and tobacco control as well as facility inspections and drug and medical device approvals.

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