FDA Policy/General

FDA Not ‘Strong’ at Succession Planning: Sherman

FDA principal deputy commissioner Rachel Sherman says the agency doesn’t do well at developing experienced successors to key leaders who are approaching retirement. “It’s not our strongest suit, to be perfectly honest,” she said at the BIO CEO & Investor Conference 2/13. “We’re getting old,” Sherman said. She has been with FDA for almost three decades and other longtime staffers, like CDER director Janet Woodcock, also have been there for many years.

She said the agency does well hiring junior workers, but has a harder time, due to salary constraints and other issues, retaining them as they climb the ranks. “The first thing that always disappears when money is tight or time is tight is training and investing in our own employees,” Sherman said. “The notion that the institutional memories could walk out the door, and will walk out the door, is scary to everyone.”

In a wide-ranging presentation on a variety of issues, Sherman:

defended FDA’s current compassionate use program, while declining to comment on any “right-to-try” legislation;
said FDA complete response letters are not the agency’s property to release unless there is a public health issue;
called on companies to share data and work together on large outcome trials to speed development of drugs for chronic conditions like heart disease and Alzheimer’s; and
said companies should contact the agency early and often rather than making the mistake of shying away from FDA.

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