Category: Corporate Compliance

9th Circuit Upholds Alameda County Manufacturer-Funded Drug Disposal Ordinance

On September 30, 2014, the U.S. Court of Appeals for the 9th Circuit unanimously upheld a lower court’s finding that a California county ordinance requiring prescription drug manufacturers to operate and finance certain drug disposal operations was constitutional.  The plaintiffs-appellants in Pharm. Research & Mfrs. of Am v. County of Alameda (9th Cir., […]

Law360 Article: “GSK Announcement May Change Industry Speaker Programs”

As we previously posted, GlaxoSmithKline (GSK) recently announced that it intends to end the practice of paying health care professionals to speak on the company’s behalf in a promotional manner.  While GSK was the first pharmaceutical company to announce this change, other pharmaceutical and medical device manufacturers may be considering similar changes.  […]

HHS Office of Inspector General Releases 2014 Work Plan: New Items Relevant to Prescription Drugs

On February 6, 2014, the U.S. Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”) released its annual 2014 Work Plan.  In addition, the OIG has posted a 25-minute video vignette featuring senior OIG executives discussing the OIG’s top priorities for fiscal year 2014.  The OIG annually […]

OIG Solicits Input for Anti-Kickback Statute Safe Harbor Regulations and Special Fraud Alerts

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Federal Register notice last week soliciting proposals and recommendations for developing new and/or modifying existing safe harbor provisions for the federal Anti-Kickback Statute (AKS) in accordance with section 14 of the Medicare and Medicaid Patient and Program Protection […]

GSK Will Stop Paying HCP Speakers, Expanding Sales Rep Compensation Structure Globally

GlaxoSmithKline (GSK) announced this week that it will stop compensating health care professionals (HCPs) for speaking on the company’s behalf regarding its products and related disease areas to other HCPs and attendees who potentially could prescribe or influence the prescribing of the company’s products.  GSK also announcenced its intent to educate HCPs by strengthening its own medical and scientific capabilities, improving the company’s multi-channel capability to provide appropriate and convenient […]