Drugs

OIG Backs Manufacturer-Sponsored Patient Tests

The HHS Inspector General (IG) has issued an advisory opinion that favorably addressed a drug manufacturer’s program to provide free antibody testing to determine whether it would be appropriate to prescribe the manufacturer’s product. Attorneys Dominick DiSabatino and Audrey Mercer (Sheppard) write in an online post on their firm’s FDA Law Update that the opinion “offers practical lessons for pharmaceutical and biotech companies contemplating similar arrangements.”

The post says the manufacturer in question contracted with a third-party laboratory to provide the testing at no cost to eligible patients. It says the IG concluded that although the arrangement would generate prohibited remuneration under the federal anti-kickback statute if the requisite intent were present, the IG would refrain from imposing sanctions on the manufacturer. The IG further concluded, the attorneys say, that the arrangement does not generate prohibited remuneration under the beneficiary inducements civil monetary penalty.

“The opinion reinforces a now well-established principle in OIG’s advisory opinion jurisprudence: manufacturer-sponsored diagnostic testing programs can be structured to satisfy both the anti-kickback statute and the beneficiary inducement civil monetary penalty, provided the program is designed with genuine diagnostic intent and rigorous structural separation from the manufacturer’s commercial operations,” the attorneys conclude.

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