Drugs

Teva Paying $54 Million to Settle Whistleblower Suit

Teva is paying $54 million to resolve whistleblower allegations by two former company sales representatives that it used sham paid speaker programs to increase the use of its Copaxone and Azilect. Allegations in the complaint focused on a scheme to induce physicians to write prescriptions for Copaxone and Azilect by paying them as “speakers” or “consultants” when, in reality, many of the programs at issue were sham events, according to a statement from an attorney for the whistleblowers. As a result of Teva's allegedly illegal payments, it says, the physicians prescribed Copaxone, which treats relapsing-remitting multiple sclerosis, and Azilect, which treats symptoms of Parkinson's disease, and influenced other prescribers to do the same.

The complaint also alleged violation of the federal anti-kickback statute.

The case was pursued despite the government’s decision not to intervene. In a 2/27/19 order, a federal judge rejected Teva’s request for summary judgment, writing that there was a genuine issue of material fact as to whether Teva had violated the anti-kickback statute. The court also said there was a genuine issue of material fact about the efficacy of the company’s compliance program. The judge said that although Teva’s written compliance policies had all of the right language, the existence of such policies had no bearing on whether the company actually adhered to them. Settlement discussions and agreement followed the judge’s ruling.

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