FDA Policy/General

Choice for FDA Chief May be Named This Week: HHS Secretary

HHS secretary Tom Price 3/6 hinted on Hugh Hewett’s talk radio show (view transcript) that an FDA commissioner nomination could be announced as early as this week. Law professor Hewett’s radio show is heard in more than 120 cities across the U.S., with an audience of over two million listeners each week.

Asked if an agency head has been nominated yet, Price said all HHS-related presidential appointees have been identified and “they’re all in various stages of being vetted and reviewed. Some, you know, they’ve got to go through an FBI background check and the whole financial vetting process that occurs. And so that’s where most of them are, and I think you’ll see some names being announced, I hope, this week, if not next.”

Hewett also asked Price about president Trump’s address to Congress that took aim at needing to expedite the FDA approval process (see earlier story). “How do you move that up if everyone agrees that they’re too slow? How do you change that culture? Hewitt asked.

Price responded: “At the FDA? It takes a leader, and I think that folks will be very, very pleased with the individual that we’ve identified and will hopefully work and get through the Senate confirmation process. It takes a leader who understands and respects the fact that getting, having a medication or a device come to market and having it take 10 to 14 years is simply too long. And we need to be responsive and accountable to our fellow citizens to make certain that we are on the cutting edge of innovation. Safety? Yes, it’s absolutely imperative that things that are on the market are proven to be safe by the FDA and other regulators, but we must not, we must not delay the length of time that it takes for things to get to market so that they can benefit individuals.”

Noticeably absent from Price’s remarks is evidence of a therapy’s effectiveness. To the consternation of many FDA watchers, Trump reportedly is considering several commissioner candidates who argue for quicker market access for therapies by limiting the effectiveness data required to gain approval (see related story).

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