Drugs

Ad Group Refers Synergy Claims to FTC

The Better Business Bureau’s National Advertising Division (NAD) has referred advertising claims made by Synergy Pharmaceuticals to the Federal Trade Commission after the drug company declined to participate in a NAD proceeding. NAD says the Synergy claims for its Trulance (plecanatide) chronic idiopathic constipation prescription drug made in online advertising, medical journals, and printed waiting room advertising, as well as through sales representative detailing, were challenged by Allergan.

Allergan challenged several specific advertising claims and also said that the advertising implied that Trulance can be used without the risk of diarrhea and is superior to its Linzess(linaclotide).

Synergy denied Allergan’s characterization of its claims, NAD says, and said that FDA has primary jurisdiction for the advertising and promotion of prescription drug products and is uniquely positioned to evaluate prescription drug advertising.

NAD says it determined that the challenged claims are within its purview, noting that it is charged with ensuring that advertising claims, in the context in which they appear, are truthful and accurate such that consumers can make informed purchasing decisions.

“While FDA has jurisdiction over the advertising and promotion of prescription pharmaceutical products, FDA jurisdiction does not preclude NAD from providing self-regulatory guidance on the challenged advertising, particularly whether the challenged advertising for Trulance communicates a misleading message about competing products,” NAD says.

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