Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth in issues and stay up to date on the latest trends. We encourage you to subscribe to our monthly publication Policy and Medicine Compliance Update.
Our feature article in the August 2021 issue of Policy and Medicine Compliance Update takes a bit of a departure from our usual articles. While it focuses on California’s latest transparency effort (AB-1278), our focus was not just on the bill’s provisions, but also on the story of how one patient’s experience and efforts drove the legislative agenda.
Next, we turn our attention to the continuing efforts to address the high costs of prescription drugs. 05 Continuing the series from last month, we focus on President Biden’s latest Executive Order and the FTC’s efforts to reign in pay-for-delay arrangements.
Of course, no issue of the Policy & Medicine Compliance Update is complete without touching on relevant litigation and enforcement developments. We start by looking at the latest developments involving the professional whistleblower firm, Integra Med Analytics, and its experiences with the Fifth and Ninth Circuit Courts of Appeal. Finally, we end the issue with another Ninth Circuit case involving Medtronic and revival of previously dismissed FDA certification claims. The outcome could change the landscape of whistleblower cases alleging fraud-on-the-FDA.
A Patient’s Perspective on Open Payments Leads to New Transparency Bill
By Dr. Seth B. Whitelaw, Editor
California is currently considering imposing new financial disclosure requirements on physicians and surgeons. However, the driving force behind AB-1278 is not the state government but a patient, Wendy Knecht. Although the legislation faces an uphill battle, Ms. Knecht’s efforts reflect a significant shift in the transparency debate with patients demanding and receiving a seat at the table to improve the physician-industry financial disclosure system.
Turning Up the Heat on Prescription Drug Pricing
Part 2 – FTC Wins on Appeal
By Gwendolyn A. Ball, Staff Writer
Recently, the FTC achieved a significant victory in its ongoing battle against pay-for-delay arrangements in the Ninth Circuit. Together with President Biden’s latest Executive Order that specifically highlighted these arrangements, it is clear that as the government continues its efforts to address the high costs of prescription drugs, there will remain a strong focus on drug company activities that are anticompetitive and ultimately hurt American consumers
Litigation & Enforcement
Three Integra Med Cases Highlight the Uncertain Future for Professional Whistleblower Firms
By Kirt Kraeuter, Staff Writer
Three recent FCA cases involving Integra Med Analytics LLC highlight professional whistleblower firms’ uncertain future. In two cases, Integra lost in the Fifth Circuit and, more recently, the Ninth Circuit. However, in the third, the Justice Department decided to intervene and join the case. What this inevitably means is unclear, but it is an area that bears watching as the stakes are high for life science companies.
The Ninth Circuit Revives FDA Certification Fraud Claims Against Medtronic
By Robert N. Wilkey, Esq., Senior Staff Writer
In a closely observed case against Medtronic, Inc., the Ninth Circuit affirmed the trial court’s dismissal of the FCA claims but revived the FDA certification claims. This case highlights the viability of FDA fraud claims regarding medical devices allegedly usable only for their contraindicated use.
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/or encourage you to subscribe for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.