The July issue of Life Science Compliance Update is available for download. This month’s publication covers a number of mid-year highlights, including the 21st Century Cures Act, enforcement targets and trends, new transparency initiatives, and practical compliance insight.
On the legislative side, the issue examines three provisions of the House of Representatives’ 21st Century Cures Act designed to modernize and clarify the way that manufacturers may communicate information about their products. You’ll also find analysis of a recent settlement implicating off-label communication. This issue then looks into the various states that have introduced pharmaceutical cost transparency legislation, a topic that has received more attention as the high prices for cures or drugs for rare diseases continue to grab headlines.
The featured article this month is entitled “Compliance for the Common Man,” by Dr. Seth Whitelaw, President & CEO, Whitelaw Compliance Group, LLC. In it, Whitelaw discusses how the expectations for increasingly expensive, robust compliance programs–as set forth in Corporate Integrity Agreements and other guidance–may not be a sustainable trend for the life science industry.
Finally, the issue offers a mid-year enforcement update, with a focus on the government’s recent efforts to prevent Medicare Part D fraud.
Go over to www.lifescicompliance.com to download a free sample issue and learn more about the publication.
July’s Table of Contents
- Mounting Pressure on FDA to Address the First Amendment