FDA Policy/General

Gottlieb Sets Recusals from Many Drug Companies

FDA commissioner nominee Scott Gottlieb has detailed how he will divest the many financial interests he has in health-related companies, and has promised to recuse himself from agency decisions involving those companies for one year after his confirmation. The information is included in a 3/29 eight-page letter Gottlieb sent to the designated ethics official at HHS.

The letter shows Gottlieb received millions of dollars in income as an adviser, executive, paid speaker, or consultant to about 20 healthcare companies, including cancer therapy startups such as Cell Biotherapy, Inc., and large drug companies such as GlaxoSmithKline and Bristol-Myers Squibb.

Gottlieb’s attorney told the media that FDA commissioners rarely are required to be involved in company-specific decisions, since their role is to set broad policy for the agency. Still, analysts say his financial disclosure is likely to fuel opposition to his nomination from those who say he is too close to the companies and industry he will regulate. In addition to being involved with a number of companies directly, he also has had speaking engagements for trade associations and individual companies that netted him over $200,000 during 2016 and the first two months of this year.

Susan Wood, a George Washington University health policy professor who resigned as director of the FDA’s Office of Women’s Health in 2005 over the agency’s decision to delay over-the counter approval of the morning-after birth control pill, told the New York Times that “if you have a commissioner who is that conflicted, recusal is a tricky business. He’s obviously well trained, he has experience, but my concern is whether he has the strength of will and the commitment to ensuring that actually the best science and the best medicine drives decisions of FDA.”

Other critics say they are more concerned about his regulatory philosophy than his financial dealings. Harvard Medical School professor Jerry Avorn told the media that a commissioner can’t recuse himself from his ideology. “Scott has been very candid that he would like a lighter regulatory touch” at the agency. Gottlieb is on the record as favoring simpler and quicker FDA product approvals in some instances.

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