Drugs

HHS Describes 2 Recent Settlements

The HHS Office of Inspector General (OIG) says settlements were reached with a drug company and a durable medical equipment company during the six months ending 3/31. In a semi-annual report to Congress covering the period 10/1/16 to 3/31, the OIG says Shire entered into a settlement agreement to resolve allegations in connection with sale of Dermagraft, a human skin substitute product, from 2007 to 2014.

According to the OIG, the company allegedly paid kickbacks to doctors who purchased Dermagraft and then billed Medicare, Medicaid, and other federal healthcare programs. Shire also allegedly paid kickbacks to doctors employed by the Veterans Administration who caused the agency to purchase Dermagraft under a contract with Shire. And, it says, the company marketed the product for unapproved uses and made false statements intended to inflate its price and to conceal, avoid, or decrease an obligation to pay money to the federal government.

In the second case described in the report, Biocompatibles entered into a settlement agreement to resolve allegations that it knowingly caused false claims to be submitted to Medicare and Medicaid. OIG says the company marketed a device known as LC Bead that was cleared by FDA as an embolization device that can be placed in blood vessels to block or reduce certain types of tumors and arteriovenous malformations. But, the report says, LC Bead was never cleared by FDA as a drug-device combination product or for use as a drug delivery device.

OIG says that when the device was combined with prescription drugs for use as a drug-eluting bead, it constituted a new combination drug-device product that was not approved by FDA and not covered by Medicare and Medicaid.

The company agreed to pay $25 million to resolve its False Claims Act liability and paid an additional $8.75 million criminal fine for misbranding the bead and a criminal forfeiture of $2.25 million.

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