December 2018 Issue Now Available

Given that this is our last issue of 2018, we decided to focus on several important topics that never seem to get enough airtime.  Therefore, we are featuring articles on privacy, including the new California Consumer Protection Act and other state legislation, controlled substances, including the new SUPPORT Act that was enacted in October, and the risks of global regulatory approvals.  Also, as is typical this time of year, we…

Whitelaw Compliance Group Presents at the 19th Annual Pharmaceutical & Medical Device Conference

On Thursday, November 8th, Dr. Seth Whitelaw will be joining a distinguished panel of experts for an interactive discussion on the evolution of the compliance office from “Compliance 1.0 to 3.0”.  The commercial compliance profession is now over 25 years old.  While the demands have changed as the commercial model has become more complex, many of the concerns have stayed the same.  Will Compliance 3.0 require a different kind of…

Open Payments 2.0 – Big Changes Are Forecast

Key Messages  Tucked into the latest opioid law are changes to the Sunshine Act. Beginning in 2022, drug and device companies now must report transfers of value to advance practice nurses and physician assistants. CMS also awarded a contract to analyze Open Payments data over the next five years. All drug and device should review both their Sunshine Act systems AND their reported payments BEFORE CMS comes knocking at the…

Drug Pricing—The Next Compliance Waterloo

My latest article co-authored with Nicodemo Fiorentino and Jennifer O’Leary is available as a free download from the Mitchell Hamline Law Review.     The current drug pricing war pits the pharmaceutical companies against doctors, hospitals, insurers, regulators, and consumers. The pharmaceutical industry has been fighting this war for more than two decades and is now engaged in a rearguard action. Their actions may delay the tidal wave of regulatory…