Drugs

Caution Advised for Continuing Education Funding: WLF

The Washington Legal Foundation (WLF) says a 7/29 HHS Office of Inspector General (OIG) advisory opinion rejecting a proposal to permit pharmaceutical and medical device industry sponsorship of a continuing education program for healthcare providers “could have significant implications for how life sciences companies contribute towards continuing education programs for healthcare providers.” The advisory opinion says the proposal was rejected because it could generate prohibited remuneration under the federal anti-kickback law.

A WLF online Legal Pulse commentary reviews the specific request submitted to the OIG and the OIG’s analysis of the various options the requestor suggested. “While OIG’s advisory opinion can only be relied upon by the requestor,” WLF says, “the agency’s conclusions about pharmaceutical and medical device industry sponsorship of a continuing education program that is organized and implemented by a healthcare provider or organization is informative and highlights the heightened risk in this area.”

The post suggests that life sciences companies proceed with caution, especially if they fund any sort of continuing education program organized and implemented by a healthcare provider. Likewise, it says, medical practices, health systems, and other organizations that implement continuing education programs should also pay attention to OIG’s conclusions about the level and scope of pharmaceutical and medical device industry sponsorship and funding.

“Whether we will see any enforcement in the continuing education space is unclear,” WLF concludes. “However, life science companies and providers should consider taking steps to review their internal policies and processes for funding and organizing educational programs and to adopt appropriate controls to minimize risk in this space.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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