Drugs

WLF Post Looks at Pfizer’s Copay Subsidy Program

Last month, the U.S. Court of Appeals for the Second Circuit affirmed a lower court’s decision that a Pfizer-planned copay subsidy program for Tafamidis, indicated for treating a rare heart condition, violated the anti-kickback statute. The program would have offered financial assistance to qualifying patients (including Medicare beneficiaries).

Writing in an online Washington Legal Foundation online post, Goodwin Procter partner Matt Wetzel notes that Pfizer earlier sought an advisory opinion from the HHS Office of Inspector General (OIG) as to whether the program would violate the anti-kickback statute, and the OIG responded unfavorably.

Wetzel’s post offers guidance on understanding OIG’s position and how drug companies can find important direction for “how to establish internal controls that pass muster under OIG’s standards.”

Wetzel contends that pharmaceutical manufacturers still have options to help financially needy patients despite the recent court ruling. “That support,” he cautions, “needs to be mindful of Medicare rules (not to mention rules that commercial payors and health plans might also have with respect to copay and cost-sharing support) and should be coupled with well-defined internal controls.”

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