Policy & Medicine Compliance Update
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June, 2021
Issue Summary:
This month we focus on two areas – the lack of regulations and compliance guidance and litigation and enforcement. We start with the murky requirements of patient support programs and the challenges for compliance professionals advising their companies. Next, we move to the lack of regulations and compliance guidance for the 340B program.
Shifting to litigation and enforcement, we start with the opioid litigation and the latest industry consultant to face liability for their role in assisting Purdue Pharma and other manufacturers. We also examine the systemic compliance failures of Emergent BioSolutions and the impact on COVID-19 vaccine production. Finally, we close out the issue with recent Incyte settlement for false claims in which, once more, the compliance officer was the whistleblower.
ARTICLES
OPERATING IN THE GRAY ZONE
PATIENT SUPPORT PROGRAMS AND THE GUARDRAILS TO MITIGATE RISK
By Marci Juneau, Partner and Benjamin J. Schein, Associate, Helio Health Group LLC
Summary: As the number and types of patient support programs continues to grow, drug and device manufacturers continue to struggle with significant regulatory uncertainty resulting in uncharted risks. Therefore, life science compliance professionals must prepare their organizations to defend the integrity and the utility of their patient support programs from every angle.
DRUG PRICING
GUIDANCE WITHOUT AUTHORITY BEGETS OVERT CHALLENGE
340B CONTRACT PHARMACY GUIDANCE & DISPUTE RESOLUTION MECHANISM CONTINUE PROGRAM UNCERTAINTY
By Gwendolyn A. Ball, Staff Writer
Summary: The 340B program, which requires drug companies to grant rebates to hospitals for some drugs dispensed to hospital patients, has long been a source of controversy. The pharmaceutical industry is overtly challenging the HHS authority to issue guidance expanding the type of pharmacies from which the discounted prescriptions can be dispensed. The industry is also challenging a dispute resolution mechanism created by HHS that the regulatory freeze had delayed during the Trump administration. Therefore, 2020 was a tumultuous year for the program, and 2021 looks to be the same.
LITIGATION & ENFORCEMENT
KRYPTONITE FOR CONSULTANTS
MASSACHUSETTS SUES PURDUE PHARMA’S MARKETING CONSULTANT
By Dr. Seth B. Whitelaw, Editor
Summary: In the latest chapter involving Purdue Pharma, the Commonwealth of Massachusetts filed suit against Publicis Health, LLC for its role in helping Purdue Pharma inappropriately market opioids. The alleged conduct mirrors that seen in the earlier suit against McKinsey & Company and it signals independent consultants cannot assume they are insulated from liability when assisting their clients’ illegal or unethical behaviors.
SERIOUS MANUFACTURING & CULTURAL ISSUES EMERGE AT EMERGENT BIOSOLUTIONS
By Gwendolyn A. Ball, Staff Writer
Summary: Recently, an essential tool in the fight against the pandemic suffered a potentially serious setback when millions of doses of the Johnson & Johnson vaccine produced by Emergent BioSolutions were discarded due to contamination. However, the story is more than a failure of good manufacturing practices, but rather a failure of the company’s compliance culture. It is a failure that was years in the making and serves as a cautionary tale for all life science compliance professionals.
ANOTHER COMPLIANCE OFFICER BLOWS THE WHISTLE
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: The recent DOJ settlement with Incyte over false claims allegations is more than a garden variety independent copay charity case. Like Olympus and Merit Medical before it, the whistleblower, in this case, was a compliance officer.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy during these challenging times. And as always, thank you for subscribing and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor
editorial@policymed.com