July 2018: Life Science Compliance Update
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By Kaitlin Fallon Wildoner, Esq.
July 2018 Issue Summary
If you are looking for a theme for this month, we suggest PAIN. From the opioid crisis to patient copay assistance it seems that despite our best compliance efforts there is no shortage of programs and antics that are resulting in painful outcomes for life science companies.
Speaking of pain, we lead off this month with Katherine Norris’s article on the current swarm of legislation to address the OPIOID CRISIS that is occupying CAPITOL HILL this summer. Following that is an article chronicling CANTRELL DRUG COMPANY’S FIVE-YEAR SAGA with the FDA and now the DOJ for CGMP issues at its COMPOUNDING facility.
Next, we take a look how compliance issues can impact a potential MERGER, especially when serious allegations of non-compliance, especially involving DATA INTEGRITY, come to light after the DUE DILIGENCE process. The court documents in the FRESENIUS/AKORN case give us a rare glimpse into that world.
Moving into the more familiar territory of kickbacks and false claims, we examine the VALEANT and PHILIDOR case which resulted in CRIMINAL CONVICTIONS for executives from both a Valeant and a Philidor. Then there is the Abiomed settlement which involved using expensive meals as inducements 15 years after the PhRMA code. Finally, we wrap it up with a look at Pfizer’s most recent CORPORATE INTEGRITY AGREEMENT involving one of the latest hot button items – PATIENT ASSISTANCE PROGRAMS and INDEPENDENT COPAY CHARITIES.
Tags: Congress, Opioids
Carolyn Greene, Esq.
Tags: CGMP, Compounding, Consent decree
Tags: Data integrity, Due diligence, Merger
Carolyn Greene, Esq.
Tags: Anti-kickback, Criminal liability, Specialty pharmacy
Robert N. Wilkey, Esq.
Tags: Anti-kickback, False claims, Meals