Drugs

Follow FDA Online Misinformation Guidance: Attorneys

Attorneys Wyatt Kernell and Sonia Nash (Cooley) say companies should carefully review an FDA 7/8 draft guidance on addressing misinformation about medical devices and prescription drugs as part of preparing any tailored response communication to be sure their communication falls within the agency’s enforcement discretion policy. Writing in an online post, Kernell and Nash say companies should consider incorporating the guidance’s principles into their medical, legal, and regulatory review process, as well as updating policies and procedures on how they handle social media communications.

The draft applies when a company voluntarily responds to Internet-based misinformation and explicitly excludes TV and radio ads, even when disseminated by firms over the Internet, such as through streamed TV shows. “The new draft guidance takes an expansive view of misinformation,” the attorneys write, “defining it as ‘positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties,’ which does not need to be specific to a company’s product in order for a company to respond.”

If companies follow the guidelines in the draft, FDA has said it does not intend to enforce applicable requirements related to promotional labeling and advertising, as well as postmarketing submission of promotional communications, the attorneys say.

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