Drugs

U.S. Intervenes in 5 Subsys Whistleblower Suits

The federal government has intervened in five whistleblower suits accusing Insys Therapeutics of violating the False Claims Act in connection with marketing its opioid Subsys, a sublingual spray form of fentanyl. A Justice Department news release says Subsys was approved by FDA in 2012 for treating persistent breakthrough pain in adult cancer patients who are already receiving, and tolerant to, around-the-clock opioid therapy.

In the suits, the U.S. alleges that Insys paid kickbacks to induce doctors and nurse practitioners to prescribe Subsys for their patients. The suit says that many of the kickbacks took the form of speaker program payments for speeches to doctors that were shams, jobs for the prescribers’ relatives and friends, and lavish meals and entertainment. The government also alleges that Insys improperly encouraged doctors to prescribe Subsys for patients who did not have cancer, and that Insys employees lied to insurers about patients’ diagnoses to obtain reimbursement for Subsys prescriptions that had been written for Medicare and Tricare beneficiaries.

The statement says that in addition to intervening and taking over responsibility for the five whistleblower cases, the government has separately pursued a number of criminal cases against Insys employees and Subsys prescribers, some of which have resulted in criminal convictions or guilty pleas, while others are still pending.

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