Drugs

Insys Settles Subsys Charges for $225 Million

The Justice Department says Insys Therapeutics is settling separate civil and criminal investigations into illegal promotion of its Subsys opioid painkiller with a payment of $225 million. A department news release says the company will plead guilty to five counts of mail fraud and pay a $2 million fine and $28 million in forfeiture, as well as paying $195 million to resolve civil False Claims Act charges.

Both the criminal and civil investigations stemmed, the government says, from the company’s payment of kickbacks and other unlawful marketing practices in connection with its marketing of Subsys, a sublingual fentanyl spray indicated to treat persistent breakthrough pain in adult cancer patients who are already receiving, and are tolerant to, around-the-clock opioid therapy.

A government charging document says that from 8/2012 to 6/2015, Insys used “speaker programs” purportedly to increase brand awareness but actually to pay bribes and kickbacks to targeted practitioners in exchange for increased Subsys prescriptions to patients and increased dosage in the prescriptions.

As part of the criminal resolution, the Justice Department says, Insys agreed to a detailed statement of facts outlining its criminal conduct with respect to the illegal marketing of Subsys.

In May, five former Insys executives were convicted after trial of racketeering conspiracy in connection with Subsys marketing, bringing to eight the number of Insys executives convicted for crimes relating to illegal Subsys marketing.

The company also is entering into a five-year corporate integrity agreement with the HHS inspector general. The government says it decided not to seek exclusion of Insys from federal healthcare programs at this time because of its extensive cooperation in the prosecution of culpable individuals and agreement to enhanced corporate integrity agreement requirements.

The civil allegations originated in five whistleblower suits. The whistleblowers will receive a share of the $195 million civil 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

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