Drugs

BMS Pays $19.5 Million to Settle Abilify Off-label Charges

Bristol-Myers Squibb has entered into a settlement agreement with 43 states to resolve allegations the company used false and misleading representations to promote its antipsychotic drug Abilify. Under the agreement, Bristol-Myers Squibb will pay $19.5 million and implement marketing, sales, disclosure and other reforms aimed at avoiding the violative conduct.

Abilify was approved in 2002 for treating schizophrenia in adults, and later for numerous other conditions, including certain bipolar disorder diagnoses. “A multi-state investigation focused on the drug’s marketing, however, found that Bristol-Myers Squibb improperly promoted Abilify for off-label uses,” a news release says. “In addition, the investigation found that Bristol-Meyers Squibb made unsubstantiated product claims about Abilify by minimizing and misrepresenting the risks associated with the drug, and improperly incentivized its sales staff to generate off-label prescriptions.”

Under the multi-state settlement, Bristol-Myers is banned for a period of five years from promoting Abilify for off-label use. The company also is banned for five years from numerous other actions including:

Compensating health care providers for merely attending a promotional activity for Abilify
Rewarding health care providers with grants based on their prescribing habits
Allowing non-scientifically trained company personnel to offer opinions about, or to summarize, off-label information
Using medical education grants – including continuing medical education grants – or any other type of grant to promote Abilify
Providing samples of Abilify to health care providers whose clinical practices are inconsistent with Abilify’s FDA-approved label

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