FDA Policy/General

Gottlieb Wants to Stay at FDA

FDA commissioner Scott Gottlieb, mentioned as a possible successor to Tom Price as HHS secretary, says he believes he can be more effective on behalf of the Trump administration in his current position. In a 10/10 interview with Reuters, Gottlieb declined to say whether he had any conversations with the White House about the HHS position that became vacant when Price resigned over his use of private jets for government business.

“I’m not going to get into private discussions I might have had around that,” he said. “I feel like I want to continue to follow through on the policies we’ve put out and it’s where I think I can be most effective.”

The news service says Gottlieb had gained mostly positive reviews since coming to FDA in May, with policies addressing opioid and tobacco addiction and rising drug prices. He told the news service that the top post at FDA has always been difficult to fill and there have been lengthy periods in which the agency has been led by an acting commissioner.

“It’s always challenging to move an FDA commissioner,” he said. “Continuity of leadership there is important.”

On other topics, Gottlieb said:

the situation in Puerto Rico, where 10% of drugs prescribed in the U.S. are made, is “very bad” and could lead to shortages in some drugs in as few as two to three weeks; and
FDA will more clearly define regulations around cell therapies.

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