Drugs

Supreme Court Acts in 2 FCA Cases

Attorney Jennifer Thomas (Hyman, Phelps & McNamara) says the Supreme Court took steps this week in two False Claims Act (FCA) cases. Writing in her firm’s FDA Law Blog, Thomas says the court first invited the Solicitor General to submit a brief outlining the government’s views on a petition from Gilead asking the court to hear its appeal of the 9^th Circuit Court of Appeal’s decision that would allow FCA cases to proceed based on FDA regulatory infractions, because the government would have the option not to pay a claim based on the noncompliance, and even if FDA’s response to the infractions indicated that it did not view the regulatory issue as material. In taking this stance, Thomas says, the 9^th Circuit set itself apart from other appeals courts’ interpretation of the Supreme Court’s Escobar decision.

“When the Supreme Court calls for the Solicitor General’s views on a petition for certiorari,” she writes, “it often acts in accordance with the Solicitor General’s recommendations (with respect to whether to grant certiorari, not necessarily with respect to the merits of the case)…. The Supreme Court may be inclined to grant certiorari in Gilead to address the 9^th Circuit’s misreading of Escobar and the FCA materiality standard.” Thomas says it often takes the Solicitor General months to file a brief in response to a Supreme Court request, so it could be some time until the government’s position is known.

In a separate FCA case, the high court declined to hear an appeal in a DuPuy Orthopedics FCA case relating to the pleading standards. Thomas says the court’s refusal to take the appeal leaves in place a 1^st Circuit Court of Appeals ruling that applied a relaxed pleading standard to a FCA complaint that alleged indirect submission of false claims. She says the 1^st Circuit took the position that it was possible for a plaintiff to adequately plead against a defendant based on a statistical certainty that false claims were submitted as a result of the defendant’s alleged actions, rather than alleging the specifics of any actual false claims.

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