Drugs

FDA to Relax ‘Speech’ Approach: Lawyer

Attorney James Beck (Reed Smith) says that based on FDA commissioner Scott Gottlieb’s previous agency and non-agency statements, he doubts “that FDA’s absolutist ban on truthful industry speech about off-label uses will continue much longer in its current form.” Writing in an online blog post, Beck quotes from several Gottlieb presentations on the subject and says that defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA commissioner’s positions, particularly to rebut contrary views offered by former FDA officials.

“Dr. Gottlieb has enough of a track record on truthful manufacturer speech about off-label uses of drugs and medical devices, and the constitutional and medical implications of suppressing it, that we are more hopeful now than we have ever been that FDA will see reason, respect the First Amendment, trust physicians, and change its science-suppressing ways,” Beck concludes.

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