Devices

Respironics Troubles Broaden as it Pays $24 Mil. Over False Claims

As Philips negotiates a consent decree with the Department of Justice (DoJ) acting for FDA over GMP issues with its troubled Respironics unit and its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines (see earlier story) , DoJ 9/1 says the company has agreed to pay over $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to medical equipment suppliers.

The DoJ settlement resolves allegations that the company caused medical equipment suppliers to submit claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory-related medical equipment that were false because Respironics provided illegal inducements to the suppliers. “Respironics allegedly gave the [medical equipment] suppliers physician prescribing data free of charge that could assist their marketing efforts to physicians,” the government contends.

News of the Justice Department’s consent decree talks comes a few months after FDA issued a rare Section 518(a) notification order (see story) to Philips requiring it to notify patients and others of the company’s 6/14/2021 recall of the ventilators, CPAP and BiPAP machines, and the “unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane sound abatement foam used in those products.” The notification order was necessary due to what the agency described as “inadequate” company notification efforts to date.

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