FDA Policy/General

Trump Talks to 2 Silicon Valley Execs About FDA Roles

President-elect Donald Trump 1/12 reportedly met with two Silicon Valley associates of billionaire tech investor Peter Thiel (see earlier story) for potential posts at FDA, according to The Hill. Trump interviewed Jim O’Neil, a managing director of one of Theil’s venture capital firms, who is high on the top FDA post list, and previously served at HHS under George W. Bush. He also interviewed entrepreneur Balaji Srinivasan, who founded a genomic testing company and works at the venture capital firm Andreessen Horowitz. Thiel had previously donated to a bitcoin startup launched by Srinivasan.

O’Neil has no medical background, unlike the past commissioners for over 50 years. And he has advocated for new radical approaches in allowing products on the market, Bloomberg notes. In a 2014 speech, he supported reforming FDA approval rules so that drugs could be given a “progressive approval,” where they are allowed on the market after demonstrating safety. “Let’s prove efficacy after they’ve been legalized,” he said at a conference called Rejuvenation Biotechnology. Srinivasan has criticized how FDA is run, sending several tweets last March that posed the agency as an obstacle to innovation, The Hill reported.

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