Policy & Medicine Compliance Update
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Issue Summary:
We begin the April issue with our second article in our “Back to Basics” series. In an interview with Roy Snell, we focused on the importance of integrity, and what that means, for the compliance profession. Enforcement issues take second billing as we focus on the latest individual indictments stemming from the Justice Department’s generic drug price-fixing investigations. Next up, is a review of the final ResMed, DME settlement and CIA.
Opioid litigation also is back in the news with Washington State’s lawsuit against J&J, which follows the Oklahoma playbook. Finally, we round out this issue with a recent Supreme Court case casting doubt whether courts will continue to defer to agency regulatory interpretations.
FEATURE
Back-to-Basics – Building a Foundation of Integrity
By Dr. Seth B. Whitelaw, Editor
SUMMARY: For the second part of our series Back-to-Basics, we focus on the building of a strong integrity foundation. What follows is an interview with Dr. Roy Snell, former CEO and co-founder of SCCE and HCCA.
TAGS: Back-to-basics, compliance, INtegrity, Snell
Enforcement
Generic Price-Fixing Cases Focus on Individuals
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: The United States Department of Justice has been investigating generic pharmaceutical companies and their executives for potential involvement in conspiracies around price-fixing and bid-rigging. In February 2020, two more former executives were indicted for their participation in the conspiracy.
Tags: generic, pricing-fixing, antitrust, indictment
It’s Final – Details on the ResMed Settlement with DOJ Emerge
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: The DOJ recently announced that it had finalized a settlement agreement with DME-supplier ResMed, following a multi-year investigation into ResMed’s business practices relating to its DME product support services. This settlement highlights DOJ’s focus on DME suppliers, and the challenges such suppliers face in dealing with this heightened scrutiny.
TAGS: Kickbacks, False claims, DME, CIA, Settlement, Medical Devices
Opioids
The Headache Continues – Washington State Brands J&J’s Opioid Business as a Public Nuisance
By Robert N. Wilkey, Senior Staff Writer
Summary: To start 2020, Washington State, following Oklahoma’s playbook filed a lawsuit against Johnson and Johnson and Janssen Pharmaceuticals, asserting their actions fueled the State’s opioid epidemic. J&J is charged with violating the State’ Consumer Protection Act, being a public nuisance and negligent by embarking on an alleged massive deceptive marketing campaign. The expectation is that Washington likely will prevail, creating further precedents for holding pharmaceutical companies liable for the public health epidemic involving opioids.
tags: opioids, api, J&J, Oklahoma, washington, public nuisance
Adminstrative law
The Supreme Court Signals an End to Blanket Deference for the FDA in Kisor v. Wilkie
By Robert N. Wilkey, Esq, Senior Staff Writer
Summary: Last year, while most of the life science compliance attention was focused on the opioid cases and other enforcement actions, the Supreme Court in Kisor v. Wilkie addressed the issue of granting deference to administrative agency decisions of ambiguous rules. Although the case received little attention at the time, its potential impact on agency decisions and actions is significant. This impact is especially true for companies awaiting actions and clarification from the FDA. If the anticipated slowdown in FDA decision making occurs, compliance professionals will need to remain vigilant to aggressive attempts to regain lost time.
