Drugs

Company Speaker Programs FCA Focus

Enforcement officials are closely scrutinizing drug and medical company speaker programs for False Claims Act violations. Attorney Matthew Curley (Bass, Berry & Sims) writes in an online blog post that drug and device manufacturers accounted for nearly half of the enforcement recoveries from the healthcare industry last year.

Curley says that speaker programs have received significant attention from enforcement agencies and whistleblowers because companies typically provide the speakers, who are also prescribers of the companies’ products, with honoraria for their involvement. If the programs are not carefully implemented and executed, he writes, companies may open themselves up to anti-kickback and false claims liability. “Last year there were mixed outcomes for pharmaceutical and medical device companies that had to defend their speaker program practices,” he says.

The post also covers other key False Claims Act issues including off-label promotion, current good manufacturing practice violations, and usual and customary pricing.

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