Policy & Medicine Compliance Update
Policy & Medicine Compliance Update
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July, 2021
Issue Summary:
This month, our focus is on litigation and enforcement, covering drug pricing, Open Payments, Opioids, kickbacks, retaliation, and labeling.
We begin our coverage with a multipart series about the increasing focus on drug pricing. In this installment, we cover AbbVie’s testimony before the House Oversight Committee and the ensuing Congressional investigation about its efforts, including various patent tactics, to restrict generic competition involving Humira and Imbruvica.
Next, we examine the issue of penalties for Open Payments violations. Although the Physician Payments Sunshine Act includes penalties, only recently has the government has started imposing them, and then as part of other False Claims Act cases. We examine those cases and their potential implications.
We also examine the most recent settlement with California involving Indivior for the improper use of Medicaid funds. The case is the latest installment in an ongoing multi-year effort to hold Indivior accountable for the inappropriate marketing of its opioid-addiction treatment, Suboxone.
In a similar vein, we examine the latest developments in the Avanir case, which has now shifted from company liability to individual liability involving former company employees and doctors. In addition, the judge rejected the original whistleblower’s claim of retaliation, and the case highlights how difficult to bring these claims.
Finally, we close out the issue by reviewing the 2020 activities and changes within the FDA’s Office of Prescription Drug Promotion (“OPDP”). Here, we assess the impact of Tom Abram’s retirement and OPDP’s current focus under new leadership.
ARTICLES
Turning Up the Heat on Prescription Drug Pricing
Part 1 – AbbVie Goes to Congress
By Gwendolyn A. Ball, Staff Writer
Summary: The House Oversight Committee has investigated how drug companies manipulate the patent and drug approval process to keep prices high. After finally obtaining internal documents from AbbVie—with a Congressional subpoena—the Committee prepared a report on the company’s practices and forced AbbVie’s CEO to testify. Based on the information it obtained, the Committee has taken the unusual step of requesting that the FTC open an antitrust investigation of the company and how it manipulated the patent and drug approval systems to block competition for its products.
Litigation & Enforcement
The Gloves Are Off
Open Payments Moves from Reporting to Penalties
By Nicodemo Fiorentino, Associate Editor
Summary: Since 2013, applicable manufacturers and group purchasing organizations have known that they could be penalized for failing or knowingly failing to timely, accurately, or completely report payments or other transfers of value or ownership or investment interest as required by the Open Payments Program. While the Centers for Medicare & Medicaid Services and the Office of Inspector General of the U.S. Department of Health and Human Services have the authority to impose civil monetary penalties, neither agency has done so. Several recent False Claims Act cases have included separate fines to settle allegations of violating the Open Payments Program. The question remains whether the Department of Justice will serve as the sole enforcer of the program’s integrity.
The Never-ending Opioid Liability Nightmare
California Extracts Another Multimillion-Dollar Settlement from Indivior Over Suboxone
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In April 2021, the California Attorney General, Rob Bonta, announced a $300 million settlement against Indivior for improper use of state Medicaid funds. While this settlement is the latest development in the Indivior opioid saga, the case has important lessons for all life science companies and compliance professionals.
Sometimes Words Speak Louder than Actions
Retaliation is Harder to Prove Than False Claims in Avanir Case
By Kirt Kraeuter, Staff Writer
Summary: While Avanir settled its False Claims matters with the U.S. Department of Justice in September 2019, its former employees and customers continue to struggle with the Nuedexta legacy. These cases provide insight to compliance professionals offering speaker program guidance, particularly following the HHS-OIG Serious Fraud Alert, and underlines the importance of maintaining clear and consistent documentation when qui tam whistleblowers face employment action.
Big Changes for OPDP
But Will They Translate into More Enforcement Letters?
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: In 2020, FDA’s OPDP issued only four Warning Letters and two Untitled Letters to pharmaceutical companies for violative promotional materials. This decrease marks a decade-long trend, and it is unclear whether new leadership at OPDP will reverse it. Nevertheless, life science compliance professionals need to remain vigilant and proactive, especially in smaller, less-experienced companies.
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