Drugs

Abbott/AbbVie Pay $25 Million in Off-Label Case

Abbott Laboratories and its spin-off AbbVie have agreed to pay $25 million to resolve allegations that they used kickbacks and off-label marketing and promotion efforts to induce physicians to prescribe cholesterol drug TriCor (fenofibrate tablets). According to the Justice Department, between 2006 and 2008 Abbott knowingly paid kickbacks to physicians and provided them with improper gift baskets, gift cards, and other items to induce TriCor prescriptions. “Abbott also engaged health care providers for consulting services and speaking engagements, where one purpose of the remuneration for the programs was to induce or reward physicians for TriCor prescriptions,” the government says.

The government notes that the FDA-approved indications for TriCor during this time period were for use, in conjunction with diet, in treating patients with hypertriglyceridemia, mixed dyslipidemia, or hypertriglyceridemia. “However, Abbott marketed the drug off-label for: (1) use in treating, preventing, or reducing cardiovascular events and other cardiac health risk; (2) use in combination with statin drugs, and (3) use as a first-line treatment of diabetic patients, including treatment to prevent or reduce cardiac health risks in diabetic patients,” it says. These uses were not FDA-approved and were not covered by federal healthcare programs.

The qui tam whistleblower suit was brought by former Abbott sales representative Amy Bergman, who will receive $6.5 million as her share of the recovery in the case.

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

Read more

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