Drugs

Off-label Promo Guidance Urged by Health Affairs

A Health Affairs blog post urges FDA to publish guidance on off-label promotion in the wake of recent First Amendment court cases that have questioned the agency’s authority to regulate off-label information. “Given the competing interests of patient health, access to information, drug safety, and the financial interest of the pharmaceutical industry, the FDA should have complete authority to provide guidance for off-label promotion in order to ensure the safety and efficacy of drugs,” the post says. “Regardless of one’s view of the practice, using the First Amendment to sort out difficult questions of off-label promotion skirts the deeper questions about these competing interests.

The blog post reviews recent FDA court losses, particularly the Amarin decision (see story)affirming the company’s ability to disseminate off-label communications, including journal reprints, to health care professionals, as long as the communications are truthful and non-misleading. “If the outcome in Amarin extends to direct-to-consumer advertising, or to claims with an inconclusive scientific basis, it threatens to undercut the mandate of and trust in the FDA,” the post says. “Undoubtedly we can anticipate further case law to delineate proper uses of the First Amendment in this context. The courts ought to exercise discretion and sound judgment, keeping the health of the public in mind as the ultimate goal.”

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