Drugs

SCOTUS Won’t Hear Appeal of Solvay Off-Label Case

The Supreme Court is refusing to hear an appeal of a 5^th Circuit Court of Appeals decision to uphold summary judgment and award costs in favor of Solvay Pharmaceuticals in a False Claims Act case. Attorneys Jennifer Thomas and Andrew Hull (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that the whistleblowers in the case said that Solvay engaged in widespread off-label marketing and violated the anti-kickback law. The appeals court agreed with the district court that the whistleblowers failed to establish, beyond mere speculation, that any alleged kickbacks or off-label marketing caused submission of a false claim.

Thomas and Hull say the appeals court in its decision discussed the materiality element in the False Claims Act, noting that if Medicaid pays for claims without asking whether the drugs were prescribed for off-label uses, and that it is not uncommon for doctors to make off-label prescriptions, then it is likely that prescribing off-label is material to Medicaid payment decisions.

The court was not required to reach the question of materiality, they say, because it had already determined that the whistleblowers had not established causation.

The whistleblowers appealed to the Supreme Court, saying that the 5^th Circuit’s comments on materiality were “sabotage of off-label enforcement” that “may well have been intentional.” The whistleblowers noted that Solvay had not raised the issue and thus the comments “suggest hostility to claims based on off-label prescription.” But the Supreme Court declined to take up the issue.

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