Drugs

AbbVie Pays $24 Million Over Calif. Humira Marketing

California has reached a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act involving the marketing of Humira (adalimumab), indicated for treating arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. “AbbVie agreed to reform its Humira marketing practices in California, including disclosing that registered nurses employed as ‘ambassadors’ to interact with patients about Humira are actually paid by the company, not a medical provider, and reforming how Humira is marketed to health care providers,” a California Insurance Department release says. Under the settlement, AbbVie will pay a combined $24 million to the state and the whistleblower who brought the case to the Department’s attention.

The state investigation began in 2016 after receiving a whistleblower case filed by a registered nurse who was employed as an AbbVie Ambassador in Florida. “The Department alleged that Nurse Ambassadors interfered with the flow of doctor-patient communications and did not directly answer questions pertaining to AbbVie marketing activities constituted kickbacks in violation of the Act, including, for example, the provision of meals and drinks to providers outside the context of speakers programs,” the release 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