FDA Policy/General

Price HHS Confirmation Hearing 1/24 Amid New Concerns

A Senate Finance Committee Hearing 1/24 will consider the nomination of president Trump’s pick to lead HHS, House Budget Committee chair Tom Price (R-GA) (see earlier story). Committee members are expected to grill Price on ethics concerns. Earlier this month, he agreed to divest stock ownership in over 40 companies if his appointment is confirmed by the Senate.

Price’s hearing comes on the heels of new ethics concerns uncovered in a Freedom of Information request involving letters from Price to CMS that show he repeatedly stepped up in favor of drug firms, device manufacturers and higher physician payments, according to a Kaiser Health News report.

“He’s clearly shown in this case and in other ways allegiance to the corporate interest, but not to the patient interest,” National Center for Health Research president Diana Zuckerman is quoted in the report as saying. “Price aligned with pharmaceutical firms in one letter, criticizing a policy meant to steer doctors away from the costliest drugs,” the report says. Another letter in 2013 would have helped major pharmaceutical firms by reducing the reports they must file on educational materials they hand out to doctors. Price and 22 other lawmakers wanted to relieve the companies from reporting what they spend giving doctors journal article reprints or textbook chapters. At the time, Medicare declined to make a change.

“Any suggestion that his motivations for public service have been anything other than seeking to improve the lives of the American people is simply wrong,” a Trump spokesman told Kaiser Health News.

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