FDA Policy/General

Promoting Talking About Bowel Symptoms

A new Ironwod Pharmaceuticals ad campaign for Linzess (linaclotide), indicated to treat irritable bowel syndrome (IBS) with constipation, is intended to ease patients’ discomfort in discussing symptoms like abdominal pain. The Boston Globe reports that ads will appear on network and cable television, the Internet, and in print and are intended to promote conversations between consumers and their healthcare providers.

“Ironwood wants to prompt reluctant patients to ask about the drug and encourage doctors more focused on life-threatening diseases to take IBS and constipation, which can restrict patients’ lives and activity, more seriously,” the article says.

Ironwood chief commercial officer Thomas McCourt says the “goal is how do we help patients help themselves. When I think about the most successful consumer campaigns in history, they’re all focused on the interaction between patients and docs.”

The article puts the new Ironwood ad in the context of renewed criticism of direct-to-consumer drug ads by the American Medical Association and others. McCort told the newspaper that he is aware of the criticism, but believes that it is important to inform patients about medicines they could benefit from and help them ask questions and make smart decisions.

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