FDA Policy/General

FTC Endorsement Guides Require Attention: Lawyer

The Federal Trade Commission (FTC) has published in the 7/26 Federal Register long-anticipated draft proposed revisions to its “Guides Concerning the Use of Endorsements and Testimonials in Advertising.” Comments can be submitted by 9/26.

An online post by Kleinfeld, Kaplan & Becker attorney Samantha Hong expects the revisions to remain “largely intact when finalized,” and recommends that companies/marketers “evaluate and update their advertising and marketing practices, especially in the social media context, to ensure ongoing compliance and to avoid becoming targets for FTC enforcement.” The attorney says some actions to consider may include:

Developing robust internal policies for endorsers regarding misleading statements and disclosure of material connections.
Establishing systems to monitor endorser activities and to take swift actions to remedy endorser non-compliance.
Developing standard disclosure policies across all social media platforms to ensure any necessary disclosures are “unavoidable” and easily understood.
Training sales and marketing personnel in FTC rules and company policies for endorsements.

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