FDA Policy/General

Drug Companies Must Assume Messaging Risks: Attorneys

Two Arnall Golden Gregory attorneys say that drug companies that want the benefits of specific messaging must assume the risks of that messaging. Commenting on a CDER Office of Prescription Drug Promotion untitled letter to Bausch Health Companies about the promotion of its Duobril (halobetasol propionate and tazarotene) topical lotion, the attorneys say that companies can’t rely on third-party programs such as a TV show or conference to ensure a promotion complies with FDA requirements, particularly if the company intends to use the material for its own purposes.

The post also says that companies are responsible for the statements and actions of their spokespeople (in this instance, a doctor and a patient). “While the statements made might have been the individual’s personal experience,” the attorneys say, “they cannot run afoul of FDA’s promotional requirement, certainly if they are not supported by sufficient data for claim substantiation.”

“To be compliant, don’t ignore FDA,” the attorneys conclude.

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