Drugs

No FDA Free Pass for Drug Industry: Columnist

Bloomberg News columnist Max Nisen says FDA commissioner Scott Gottlieb may not always be the friend the drug industry expected to see in the commissioner’s office. Nisen’s column says that Gottlieb is the only Trump administration official to follow through on the president’s rhetoric about high drug costs.

“With an eye to bringing down prices,” Nisen writes, “Gottlieb has presided over record generic drug approvals and a multi-year high in novel drug approvals, while also working to speed more medical devices to market. His agency has suggested it might be more flexible in approving drugs and will try to get cancer drugs to market more quickly, using data from smaller and faster clinical trials…. This is not exactly what Gottlieb’s critics expected, and it’s probably not fulfilling all of biopharma’s fondest hopes for his tenure either. The industry isn’t monolithic; different sectors have different priorities, and Gottlieb’s impact will vary accordingly.”

Nisen points out that nothing Gottlieb is doing has as much impact as the price curbs employed in other countries. But, he says, the industry “is definitely not getting a free pass in 2018.”

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