Drugs

Bill Introduced to Ban Misleading DTC Ads

U.S. Rep. Abigail Spanberger (D-VA) has introduced a bill entitled the Banning Misleading Drugs Act that is intended to prevent manufacturers from obscuring dangerous side effects of their prescription drugs in their advertisements and to help consumers make informed decisions. The measure would require FDA to finalize a 15-year-old proposed rule “clarifying that drug ads must include a statement related to side effects, contraindications, and effectiveness — while also prohibiting distractions from neutral information,” the lawmaker said in a release.

She said studies show that a television drug advertisment’s visuals that run alongside discussions about side effects of a drug “distracts American consumers from the risks. If enacted, this rule would prevent advertisements from including ‘distracting representations’ — including statements, text, images, or sounds — that detract from the communication of the major statement.”

Spanberger’s bill addresses a delayed rule that was mandated by the Food and Drug Administration Amendments Act of 2007, which required the agency to draft and finalize within 30 months of passage standards determining how side effects can be presented in pharma ads. “FDA has now missed that deadline by more than a decade,” she complained.

The measure is co-sponsored by Reps. Susan Wild (D-PA), Cindy Axne (D-IA), Katie Porter (D-CA), and Angie Craig (D-MN).

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