Drugs

Ex-Drug Co. CEO Pleads Guilty to Bribery

Former Insys Therapeutics CEO Michael Babich has pleaded guilty in Massachusetts federal court for his role in a nationwide scheme to bribe physicians to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. Late last year, formr company vice president Alec Burlakoff also pleaded guilty in the scheme (see earlier story). Babich, who faces up to 25 years behind bars, has also agreed to cooperate with investigators.

In pleading guilty, Babich admitted he used the company to bribe doctors into prescribing Subsys to patients who did not have cancer — a scheme that ended up lining his own pocket with $3.5 million more in profit, an amount he agreed to forfeit. Those physicians would write Subsys prescriptions for no legitimate medical purpose, according to prosecutors. Babich and other officials disguised bribes and kickbacks in the form of speaking fees, the government said.

Last August, Insys reached an agreement in principle with the Department of Justice to pay $150 million to settle a civil and criminal investigation into its inappropriate sales and commercial practices. The agreement called for Insys to pay the fine over five years, with the potential for contingency-based payments that could add another $75 million. The company says that the final settlement would include other material non-financial terms and conditions which will be subject to negotiation.

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