Life Science Compliance Update

September 18, 2017

Ohio Drug Distribution Verification: America’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain

Prescription

The pharmaceutical industry faces monumental challenges in the age of globalization within the United States: state laws and regulations that are more stringent than their federal counterparts. This article provides the historical context and current overview of Ohio’s laws, regulations, and sub-regulatory guidance concerning the distribution of prescription drugs, including drug samples, into and within the state, the verification requirements when distributing product to terminal distributors of dangerous drugs and prescribers, record retention responsibilities, and penalties for noncompliance. The article then examines the industry’s response from a major manufacturer, a distributor/third-party logistics provider, verification vendor, and compliance advisory vendors. It concludes with a call to action to the industry to form a new coalition to address state legislative and regulatory actions that have the potential to disrupt the entire supply chain.

The pharmaceutical industry faces a major dilemma: active state legislatures, administrative agencies, and state attorney generals. There is a plethora of reasons why states have turned their attention towards the manufacturers and trading partners, such as wholesale distributors and third-party logistics providers (“3PLs”). There is an opioid crisis gripping the nation, an ever-growing increase in healthcare costs, unstoppable negative publicity aimed at the pharmaceutical industry, an emboldened citizenry demanding their legislatures to do something, hospital and insurance lobbies joining the fight. As a result, state politicians are using all of this to their advantage to pass laws aimed at the industry.

This article discusses a law that has been on the books for over forty years, and amended numerous times, including a 2017 revision that lead to Ohio becoming pharma’s “key battleground state.”

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September 06, 2017

This Isn’t Walmart: The Supreme Court Narrows Forum-Shopping Options

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In a decision of great import to pharmaceutical and device companies, the Supreme Court ruled in favor of Bristol- Myers Squibb in a jurisdictional argument at the nation’s Highest Court. This article outlines the background, the case decision, and the decision’s ramifications to companies.


As the arguments about why pharmaceutical prices are rising so quickly grow more contentious, so too has the debate about tort reform and products liability. Recently, during one of last days of its most recent term, the United States Supreme Court (“SCOTUS”) issued a decision that will make it harder for plaintiffs to sue corporations in state courts for damages caused by manufacturers’ products. The nearly unanimous decision in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County, et al., has been hailed as “one of the most important mass tort/product liability decisions.”

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September 05, 2017

The Fine Art of Policy Management

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Management of corporate policies is a primary challenge for compliance officers in today’s life sciences sector. Recent guidance from the Justice Department and OIG-HHS about effective compliance programs does elaborate on what a strong policy management program should do. In this article, we examine five basic abilities that all policy management programs should have—things that your program must be able to do, regardless of your organization’s specific structure and processes, if you want an effective program that can endure in today’s highly regulated environment.


Successful policy management is crucial to the compliance program for any large organization, and especially so for a highly regulated field such as the life sciences or pharmaceutical sectors. Every skilled compliance professional already knows this.


More elusive is a keen understanding of just how policy management can work well. The challenge is one part technology, certainly. Another key to success is a strong grounding in your company’s mission and core values; they are the foundation upon which all policies will be built.

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