We are pleased to launch Life Science Compliance Update, a monthly compliance resource for pharmaceutical, biotechnology, and medical device companies. Each issue offers attorneys and compliance professionals a one stop shop for up-to-date, accurate compliance news and analysis. With input from industry experts and featured articles from leaders across the healthcare sphere, Life Science Compliance Update is a must-read for those operating in the increasingly important and ever-evolving compliance field.
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This sample issue to Life Science Compliance Update looks back on what was a busy 2014 for the pharmaceutical and device industry, including:
*Update on Sunshine
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This sample issue to Life Science Compliance Update looks back on what was a busy 2014 for the pharmaceutical and device industry.
On the enforcement front, the Department of Justice was very active negotiating settlements involving kickback allegations. We look at the government’s activity in this space. The Physician Payments Sunshine Act was also a priority for the life science industry in 2014—this issue examines the rocky roll-out, the Open Payments data, and CMS’s often confusing interpretation of the continuing medical education reporting requirement. In keeping with the increasingly global nature of transparency, we also provide a useful resource for compliance with the EFPIA Disclosure Code. Finally, this issue provides an overview of three central antitrust issues facing the pharmaceutical industry, including the latest cases and legislation affecting competition.
Table of Contents
Pharmaceutical and Device Enforcement Activity
- 2014 Settlements Focused on Kickbacks
- Anti-Kickback Alert: Pharmaceutical Copayment Coupons and Medicare Part D
- District Court Slashes $9 Billion Punitive Damages to $37 Million in Actos Lawsuit
Update on the Physician Payments Sunshine Act
- Problems in Open Payments System Roll-Out
- Sifting Through The Open Payments Data
- CMS Finalizes Rule Removing Explicit CME Exemption; Most Accredited CME Speaker & Attendee Payments Still Excluded Under Other Sunshine Act Provisions
Antitrust Landscape for Pharmaceutical Companies
- REMS And The Fast GenericsAct Of 2014
- New York AG Sues Actavis over “Forced Switching”
- Pay-for-Delay: FTC Brings Pay-For-Delay Lawsuit, Its First Since the Supreme Court Analyzed the Issue in FTC v. Actavis; AstraZeneca Wins Huge Pay-For-Delay Case Involving Its Nexium Drug
- EFPIA Disclosure Code – Country-By-Country Code Resource