Drugs

Pacira Paying $3.5 Million for FCA Kickback Charges

The Department of Justice (DoJ) says Pacira Pharmaceuticals will pay $3.5 million to resolve allegations that it paid kickbacks to doctors as bogus research grants to induce them to prescribe its Exparel (bupivacaine liposome injectable suspension) non-opioid analgesic. A DoJ statement says the allegations arose from a False Claims Act whistleblower complaint.

The government alleges that from 12/1/12 through 4/30/15 Pacira paid disguised kickbacks in the form of research and other grants to healthcare providers and institutions.

As part of the settlement, the statement says, the pharmacist whistleblower who brought the misconduct to the government’s attention will receive about $520,000 of the recovery from the federal share of the settlement and about $118,000 from the state share of the settlement.

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