Drugs

FCA Materiality Issue May Go to Supreme Court

Attorneys Anne Walsh and Rachel Hunt (Hyman, Phelps & McNamara) say the Supreme Court is considering a Gilead petition asking it to rule on a question involving “materiality” in False Claims Act (FCA) cases. Writing in their firm’s FDA Law Blog, the attorneys say Gilead’s question arises from a case in which a whistleblower alleged that the company concealed information from FDA about contamination of certain drugs, leading to false claims being paid by the government.

The case was dismissed twice by a federal district court but the 9^th Circuit Court of Appeals overturned the dismissal, holding that whether allegations are material for purposes of a FCA claim raised matters of proof that could not be resolved prior to discovery.

Gilead asked the high court to consider “whether an FCA allegation fails when the government continued to approve and pay for products after learning of alleged regulatory infractions and the pleadings offer no basis for overcoming the strong inference of immateriality that arises from the government’s response.”

The plaintiffs in the Gilead case have given the court three reasons why it should not grant the company petition to hear the case, Walsh and Hunt write. The plaintiffs say that Gilead misrepresented the 9^th Circuit decision as overly restrictive. They also cite a Department of Justice memo to support their position that the case does not undermine FDA’s regulatory authority, and they argue that there is no circuit split and that this is a poor vehicle to clarify the materiality standard because it is not clear that the government actually had knowledge of the fraudulent conduct at the time it made the payments.

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