Drugs

Pfizer Settles False Claims Case for $23 Million

Pfizer will pay $23.85 million to resolve claims that it used a foundation to pay copays of Medicare patients taking three company drugs. A Justice Department news release on the settlement identifies the Pfizer drugs as Sutent and Inlyta, which both treat renal carcinoma, and Tikosyn, which treats arrhythmia in patients with atrial fibrillation or flutter.

The department says that under the anti-kickback law, drug companies can’t offer, directly or indirectly, any remuneration, including paying patients’ copay obligations, to induce Medicare patients to buy the company’s drugs.

The government alleged that, in order to generate revenue, and instead of giving Sutent and Inlyta to Medicare patients who met the financial requirements for Pfizer’s existing free drug program, the company used a third-party specialty pharmacy to transition certain patients to the foundation, which covered their Medicare copays. Pfizer allegedly made donations to the foundation to enable it to cover the copay costs and received confirmation from the foundation, through the specialty pharmacy, that the foundation funded the copays.

For Tikosyn, the department says that Pfizer raised the wholesale acquisition cost by over 40% in the last three months of 2015, knowing the increase would also increase Medicare beneficiaries’ copay obligations and potentially prevent some patients from affording the drug. Pfizer allegedly worked with the foundation to create and finance a fund for Medicare patients suffering from the condition treated by Tikosyn, coordinated the opening of the fund with the implementation of its drug price increase, and referred patients to the fund.

Pfizer also has entered into a corporate integrity agreement with the HHS inspector general.

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