The Eighth Annual Compliance Year-in-Review presentation is now available through Potomac River Partners. This presentation is typically the “kickoff” of the CBI Pharmaceutical Compliance Congress, but this year, due to weather related-issues, it was not presented.
The presentation is a comprehensive recap of key compliance events from 2015, including settlements, new laws and guidance, and industry news. According to Potomac River Partners, clients have shared the downloadable presentation with their Board of Directors, Compliance Committee, and other senior-level executives, even sharing the Year in Review at national sales meetings or as part of a live compliance training.
Federal Settlements
One of the first topics the Year in Review presentation broaches is federal settlements. The presentation starts in January 2015 with the $39 million Daiichi-Sankyo settlement to resolve False Claims Act and kickback allegations, and goes through to December with the $39 million Endo settlement, and the Dynasplint Systems $10 million settlement, both resolving False Claims Act allegations. Potomac River Partners kept track of all of their featured settlement by month at the bottom of each slide; therefore, the very last December slide shows all companies who made a settlement to resolve the following non-exhaustive issue list: False Claims Act allegations, Foreign Corrupt Practices Act allegations, kickback allegations, and rebate and marketing issues.
State and Civil Settlements
Potomac River Partners then lists select state settlements, including settlements in states like Texas, Oregon, and New York. That information is followed by an infographic that stacks civil settlements against each other, for an easy way of seeing civil settlement amounts, the companies who settled, and for what allegations.
Changing State Law Landscape
A particularly helpful portion of the presentation is the “Changing State Law Landscape” part. The presentation goes through several states, and alerts readers to the changes that were made, allowing readers to then delve into further research on the changes.
Drug Pricing
It has been a long time, if ever before, since drug pricing has been in the headlines in the ways it has been starting in 2015, starting with Turing’s price hike of Daraprim. The presentation shows other companies who also came under fire for pricing issues, and the focus Congress has started to have on the industry as a whole. The presentation also includes a slide that shows which states have introduced, or adopted, new legislation relating to drug pricing.
Other Key Compliance News
The bulk of the presentation closes out with slides on miscellaneous healthcare compliance news, and information on the heightened levels of enforcement worldwide, including countries such as China and Romania. Additionally, there are several slides about international compliance news, touching upon countries like Australia, France, and the entire European Union.
2016 Preview
The last few slides are very small font of many compliance issues that have already begun to take center stage in 2016, highlighting for readers the important issues and what to be on the lookout for as the year progresses.
We encourage our readers to download the Year in Review presentation. If you need to catch up on past years, presentations are available for years 2008 through 2014.