FDA Policy/General

FDA Communications Reflect Gottlieb Style: Analysis

Attorney Mark Senak (FleishmanHillard) says that while the number of FDA news releases has remained generally consistent over the last few years, changes in substance and style reflect differences between commissioner Scott Gottlieb and former commissioner Robert Califf. Writing in his Eye on FDA blog, Senak says that the agency issued 164 news releases in 2017, comparable to relatively similar numbers in 2013, 2014, and 2015. The outlier was 2016 when only 122 releases were issued.

Gottlieb, Senak says, “has made liberal use in conveying information via the issuance of ‘Commissioner Statements.’ In fact, in 2016 there was just a single such statement issued by then commissioner Robert Califf. In 2017 there were 36, one of which was made by Dr. Califf and the balance by Dr. Gottlieb…. It is a way for Dr. Gottlieb to mark progress on a number of fronts and signal for the attention of key stakeholders. It is also a means for putting his personal stamp or brand on what is happening at FDA.”

One reason for the higher number of news releases in 2017, Senak says, is the increase in the number of approval announcements. In 2017, there were 77 approval related announcements of either a new drug, device, biosimilar, or other medical product, compared to just 59 the year before.

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