FDA Policy/General

Revised PhRMA Code Now in Effect

A revised Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals took effect 1/1. Attorney Faraz Siddiqui (Hyman, Phelps & McNamara) says many of the code’s changes involve drug manufacturer practices covering speaker events, including meals, choice of venue, and attendance.

Writing in his firm’s FDA Law Blog, Siddiqui says that although the code is voluntary, companies should consider updating their marketing policies and practices to align with it. He notes that the revision incorporates the latest guidance from the HHS Inspector General, including an 11/2020 special fraud alert outlining the Inspector General’s enforcement focus on speaker programs.

Another reason to update company policies, Siddiqui writes, is that several states have adopted or incorporated the code in their laws or regulations and may have a manufacturer obligation to update their practices.

“Given these state requirements,” Siddiqui concludes, “following the PhRMA Code is not only an approach to mitigate litigation risk, it is an explicit requirement for manufacturers that interact with healthcare practitioners in a state that has adopted or incorporated the code.”

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’

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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

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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