Drugs

Endo Paying $1.5 Billion Fines, Forfeitures

Endo Health Solutions has been ordered to pay $1.086 billion in criminal fines and an additional $450 million in criminal forfeitures related to distributing misbranded Opana ER, an opioid medication. In a statement, the Department of Justice says the company pleaded guilty on 4/18 to one count of introducing misbranded drugs into interstate commerce. The department says it is the second-largest set of criminal financial penalties ever levied against a drug company.

In pleading guilty, the department says, Endo admitted that from 4/2012 through 5/2013, certain company sales representatives marketed Opana ER to prescribers by touting its purported abuse deterrence, tamper resistance, and/or crush resistance, despite a lack of clinical data supporting the claims.

The statement says Endo admitted that certain sales managers were aware that the sales representatives were making claims of purported abuse deterrence, tamper resistance, and/or crush resistance when marketing Opana ER to prescribers, and that certain sales representatives were striking non-medicated sample pills with hammers and conducting other demonstrations to convey the message that Opana ER was crush-proof and tamper resistant.

“The approved labeling for Opana ER did not provide adequate information for healthcare providers to safely prescribe Opana ER for use as an opioid that is abuse deterrent,” it says. “According to the plea agreement, Endo was responsible for the misbranding of Opana ER by marketing the drug with a label that failed to include adequate directions for its claimed abuse deterrence use, in violation of the Federal Food, Drug, and Cosmetic Act.”

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