Drugs

Assertio Pays $3.6 Million Over Improper Marketing

Assertio Therapeutics, formerly known as Depomed, has agreed to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission of false claims for the transmucosal immediate-release fentanyl (TIRF) drug Lazanda for individuals who did not have breakthrough cancer pain. The fentanyl nasal spray, according to the government, is FDA-approved solely for break-through cancer pain in patients who are already receiving and who are tolerant of opioid therapy for their underlying persistent cancer pain.

The FDA Office of Criminal Investigations co-investigated the case which alleges that, between 2013 and 2017, Assertio (Depomed at the time) caused the submission of false claims to the Medicare and TRICARE programs by focusing its marketing on pain specialists who were high-volume prescribers of TIRF products, including those who were flagged for diversion or who were later indicted. Assertio also placed these prescribers on its speakers’ bureau and advisory boards, the government contends, adding that the marketing efforts caused prescribers to write Lazanda prescriptions for Medicare and TRICARE beneficiaries who did not have breakthrough cancer pain.

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