Drugs

Indivior Pays $600 Million in Opioid Marketing Case

Indivior Solutions has pleaded guilty to one felony count and agreed to pay a total of $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment Suboxone (buprenorphine). An earlier $1.4 billion resolution with Indivior’s former parent, Reckitt Benckiser Group, and a plea agreement with Indivior former CEO, Shaun Thaxter, brings the total resolution to more than $2 billion — the largest settlement involving an opioid drug, according to a Justice Department release. Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms.

The current plea by Indivior Solutions was to a one-count felony criminal information charging false statements relating to health care matters. “Indivior Solutions admitted to making false statements to promote the film version of Suboxone (Suboxone Film) to the Massachusetts Medicaid program (MassHealth) relating to the safety of Suboxone Film around children,” the release says.

“Specifically, Indivior Solutions admitted that, in 10/2012, it sought to convince MassHealth to expand Medicaid coverage of Suboxone Film in Massachusetts and sent MassHealth false data indicating that Suboxone Film had the lowest rate of accidental pediatric exposure (i.e., children taking medication by accident) of all buprenorphine drugs in Massachusetts, when in fact, it did not,” the government contends. “Indivior Solutions further admitted that sending the false and misleading information occurred in the context of marketing and promotional efforts directed at MassHealth, which were overseen by top executives.”

In addition to the financial penalties, the agreement included novel provisions that:

Require Indivior to disband its Suboxone sales force and not reinstate it;
Prohibit Indivior from using data obtained from surveys of health care providers for marketing, sales, and promotional purposes;
Require Indivior to remove health care providers from their promotional programs who are at a high risk of inappropriate prescribing; and
Make Indivior subject to contempt sanctions by the court and reinstatement of the dismissed charges if it violates the agreement.

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