FDA Policy/General

DoJ Defends 'Fraud-on-FDA' in 1 Specific Case

While declining to intervene in a whistleblower case involving Trividia Health blood glucose meters, the Department of Justice (DoJ) has filed a “statement of interest” with a Florida federal court that provides a “vigorous defense” of the “fraud-on-FDA” theory of liability. Writing in Sidley’s False Claims Act Enforcement and Litigation, three of the company’s attorneys say the department argued that when a manufacturer perpetrates a fraud on FDA by hiding material information concerning the safety or efficacy of a medical device and federal healthcare programs then pay for that device, that fraud may be “integral to a causal claim leading to payment” and thus can be actionable under the False Claims Act.

The attorneys write that the DoJ reasoned that when federal healthcare programs are deciding whether to pay for a drug or medical device, they rely on FDA to determine whether the product is safe and effective. FDA, the department said, relies on manufacturer compliance with the Federal Food, Drug, and Cosmetic Act.

“DoJ took the position that where a defendant’s false statements ‘masked problems’ that ‘would have prompted FDA to institute or require a medical product recall, subsequent claims relating to the affected devices could be rendered ‘false or fraudulent’ because the government would not have paid the claims for those affected devices but for the defendant’s conduct,” the attorneys say.

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