Policy & Medicine Compliance Update
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JUNE 2019 Issue
Issue Summary:
Summer is now upon us and we are at the half-way mark for 2019. This month we start our coverage with three recent and important developments highlighting the importance of effective compliance – the Rochester Drug Co-operative Case, and the DOJ’s updated guidance documents on evaluating an effective compliance program and receiving cooperation credits. Next, Melisa Williamson takes examines trust in the context of compliance culture. We also take a look at another facet of transparency involving documents produced in litigation in light of a recent Third Circuit Court of Appeals decision. Finally, we review what is perhaps the final chapter in Allergan’s attempt to use the St. Regis Mohawk tribe to protect its Restasis patents now that the Supreme Court refused to hear the case.
FEATURE
Renewed Focus on the Importance of Effective Compliance – Analyzing the Recent Rochester Drug Co-Operative Case and DOJ Updated Compliance Guidance
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: Recently, the DOJ, in conjunction with the DEA, announced a DPA with Rochester Drug Co-operative, as well as indictments of its Chief Executive and Chief Compliance Officers. Almost simultaneously, the DOJ announced a refresh of its previous guidance on evaluating the effectiveness of compliance programs and cooperation credits. When viewed together, this is a strong signal of DOJ’s renewed focus on the importance of having effective corporate compliance programs, and all life science compliance professionals should take note.
TAGS: DOJ, Rochester Drug Co-Operative, Effective Compliance, Controlled Substances, Cooperation Credit
CULTURE
Trust, not Verify – The Limit of Our Efficiency is the Limit of Our Trust
by Melisa Williamson, Director of Compliance, Pharm-Olam
Summary: Here, we explore the usefulness of transparent discussions about risk and how they can directly lead to more efficient procedures by relying on trust rather than verification. These conversations can be hard to have since they require a high level of honesty and vulnerability on the part of all involved. A method is proposed to directly address risks, pain points, and inefficiencies to achieve the best outcome for patient safety and data integrity.
TAGS: Compliance Culture, Validation, Verification, Patient Safety, Data Integrity
Drug Pricing
The Executive Branch Perspective on Drug Pricing
By Gwendolyn Ball, Staff Writer for Policy & Medicine Compliance Update
Summary: The topic of drug pricing and its effect on healthcare remains an active area even as other “hot button” topics dominate the news cycle. This article, therefore, will review the regulatory changes instituted in the executive branch specifically intended to reduce prices.
TAGS: Congress, Drug Pricing, White House, FDA, Pricing Transparency
Transparency
Another Twist to Transparency – Transparency in Litigation
By Dr. Seth B. Whitelaw, Editor, Policy & Medicine Compliance Update
Summary: The recent opinion of the Third Circuit Court of Appeals in the GSK Avandia Sales Practices and Product Liability Litigation adds a new transparency twist that all life science compliance professionals, and attorneys, need to consider when advising companies on the Impact of discovery to avoid ultimately losing the war after the litigation battle is won.
TAGS: Transparency, First Amendment, Right to Access, Rule 26, GSK
UPDATES, SHORTS & BRIEFS
The Final Chapter of Allergan’s Failed Effort to Join Forces with the Saint Regis Mohawk Tribe (Or is it?)
By Robert N. Wilkey, Esq., Senior Staff Writer, Policy & Medicine Compliance Update
Summary: In the final chapter of Allergan’s attempt to shield its Restasis patents by transferring them to the St. Regis Mohawk tribe to take advantage of the sovereign immunity Native American tribes enjoy, the U.S. Supreme Court refused to hear the case. This update recaps the history of the case and the Supreme Court’s refusal to take up the case. For compliance professionals the case is worth studying both as a novel patent protection strategy and for the potential negative impact these strategies can have on a company’s reputation and resources.
TAGS: Patents, Native Americans, Tribal Sovereignty, Allergan
