Drugs

Kaléo Paying $12.7 Million to End False Claims Case

Virginia pharmaceutical manufacturer kaléo has agreed to pay $12.7 million to resolve a whistleblower’s allegations that it caused the submission of false claims for its Evzio, an injectable form of naloxone HCl indicated for use to reverse opioid overdose. A Department of Justice statement says that between 3/14/2017 and 4/30/2020 the company directed prescribing doctors to send Evzio prescriptions to certain preferred pharmacies that then (1) submitted false prior authorization requests for Evzio that misrepresented to insurers that the prescribing doctors submitted the request, and (2) dispensed Evzio without collecting or attempting to collect co-pay obligations from government beneficiaries.

“The United States contends that kaléo knew of or deliberately ignored this pharmacy misconduct, but nevertheless kept directing business to these pharmacies,” the department says. “The United States also alleges that kaléo provided illegal remuneration to prescribing physicians and their office staff in violation of the anti-kickback statute to induce and reward their prescribing of Evzio.”

The former kaléo employee who brought the whistleblower charges will receive $2,548,600 of the settlement amount.

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