Devices

Ex-Advanced BioHealing CEO Settles Marketing Suit

Former Advanced BioHealing chairman and CEO Kevin Rakin has agreed to pay the government $2.5 million to settle False Claims Act allegations that he knowingly allowed company sales representatives to use kickbacks and other unlawful methods to induce clinics and physicians to use or overuse its Dermagraft product. The bioengineered human skin substitute is approved by FDA for treating diabetic foot ulcers. “Kickbacks that incentivize the sale of medical devices undermine the integrity of our health care system,” U.S. Attorney Maria Chapa Lopez is quoted in a release as saying.

The settlement resolves whistleblower allegations that Rakin allowed Dermagraft salespeople to “unlawfully induce clinics and physicians with lavish dinners, entertainment, and travel; medical equipment and supplies; unwarranted payments for purported speaking engagements and bogus case studies; and cash, credits, and rebates, to induce the use of Dermagraft,” the government contends.

In 2011, Shire plc acquired Advanced BioHealing and named Rakin president of its newly-formed subsidiary, Shire Regenerative Medicine. In 2017, Shire paid the U.S. $350 million to settle similar federal and state False Claims Act allegations related to Dermagraft’s promotion, the government says.

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