Life Science Compliance Update

October

2017

The Never-Ending Saga of Off-label Promotion

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Jenny McVey, Associate Director, FRA Life Sciences

The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing position on off-label communication; however, in light of recent federal lawsuits that have increased the uncertainty of its enforceability, as well as the growing need for data-driven medicine, the agency has been under pressure more than ever to update their regulatory position. This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication.


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September

2017

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

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Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC; John Patrick Oroho, Esq., Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC; Teresita Weiss, Ph.D., J.D., Sr. Vice President, Regulatory Affairs and Compliance, for J. Knipper and Company, Inc.; Bryan Andrews, Director of Sales Operations, MedPro Systems LLC.

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.


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August

2017

Arizona to Allow Pharma Companies to Legally Communicate Off-Label Treatment Options

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

Arizona was the first state to bite the bullet and allow pharmaceutical companies to communicate off-label uses of their drugs to physicians and other healthcare professionals. This article not only discusses the Arizona bill but also outlines some factors that may help us to understand where the landscape is heading on this issue.


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August

2017

Off-Label Bills Garner Minimal Traction in Congress

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

Further muddying the off-label waters is the fact that Congress has introduced several bills, attempting to legislate off-label use. Both bills were initially introduced as attachments to the FDA reauthorization bill, but when House Democrats resisted, both sponsors pulled the bills as attachments. On July 12, 2017, the Subcommittee on Health held a brief hearing on both bills, giving industry and others a chance to speak on off-label promotion.


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August

2017

New Leadership at the FDA Brings Change

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time, there has already been various regulatory changes and shifts, in terms of policy guidance, as well as a new focus toward easing the Agency’s rules and regulations pertaining to off-label uses. The article will explore those changes and the Agency continues to refine the “intended use” rules.


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July

2017

This is Not Your Parent’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies

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Patrik Florencio, Esq., Steven Franchetti, Seth Whitelaw, J.D., LL.M., S.J.D.

At the 14th Annual CBI Pharmaceutical Compliance Congress held in April 2017, almost half the attendees were from small to mid-sized companies that generate $3 billion or less in annual revenue. At the same time, the compliance burdens for all pharmaceutical companies continue to increase. This article explores the output of industry experts in attendance at CBI’s small to mid-sized breakout regarding the need for minimum compliance program resources as well as survey data showing that certain companies are funding their compliance programs in line with these needed minimum resources.


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June

2017

“White Coat” Marketing Gone Awry

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Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

Achieving patient adherence to prescribed medication through clinical educator programs is not a new concept. Neither is the U.S. Office of Inspector General of the Health and Human Services longstanding concern of the inherent issues these programs pose to when offered and provided by the pharmaceutical industry. A recently unsealed False Claims Act whistleblowers’ complaint provides an example of the delicate balance companies face in ensuring compliance with federal and state laws, regulations, sub-regulatory guidance, and industry codes. Expect additional cases in the future, especially if you think your “compliant” educator program is a pandora’s box.


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May

2017

Whack a Mole – Pricing Bills Keep Popping Up Everywhere

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Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

Over the last several years, the pharmaceutical industry has seen a steady increase in state legislation targeting the cost of prescription drugs. Although the cost prescription of drugs account for a small fraction of healthcare costs within the United States, the industry cannot escape being the number one target. The 2017 legislative session makes it clear that pharmaceutical manufacturers remain surrounded on all fronts. This article examines those states that succeeded in 2016, legislation that has been introduced in 2017, and the rough road ahead.


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April

2017

340B and You – Thoughts on Program Oversight for Pharmaceutical Manufacturers

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Chris Cobourn, Managing Director, Huron Life Sciences

The 340B Drug Discount Program plays an important role in the United States healthcare system by providing healthcare services primarily to entities that serve low-income populations. The program also is complex and evolving, so compliance challenges will abound for years to come. This article examines those complexities and compliance challenges.


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March

2017

Privacy Regulation: The Final Frontier of Life Science Compliance

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Matthew Gunzenhauser

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the first in a two-part series.


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February

2017

Avoiding the Patient Assistance Program Spotlight

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Kristin Rand, JD, MS, Compliance Officer, Seattle Genetics

In efforts to understand the rising cost of some drugs Patient Assistance programs, particularly independent foundations, have become a focus of government investigations. This article explains what PAPs are, why they may be viewed as suspect and provides tips for providing patient assistance in a compliant manner.


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January

2017

Feeling Needy – The Why, What and How of Needs Assessments

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Tynan P. Olechny, MBA/MPH, CVA, Consulting Principal, PYA, and Christina L. Hummel, MBA, Senior Consultant, PYA

Given trade association guidance and recent government involvement in life sciences transactions, this article emphasizes the importance of developing and implementing needs assessments related to engaging healthcare professionals to provide services to pharmaceutical or medical device companies. It describes a four-step process for identifying and documenting the business purpose of such arrangements, including 1) developing and implementing a written needs assessment policy, 2) identifying the business purpose, 3) completing a provider analysis, and 4) addressing additional considerations and documenting the need.


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December

2016

The Seventeenth Annual PCC: Day 1 Highlights

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

The Annual Pharmaceutical and Medical Device Compliance Congress is an important opportunity for industry compliance professionals and regulators to exchange information and learn from one another. This year was no exception and this article briefly recaps the highlights from the conference’s first day.


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November

2016

Value Based Contracts and Government Pricing – A Cross Functional View

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Chris Cobourn, Managing Director and Clay Willis, Director Huron Life Sciences

Value Based Contracts are becoming increasingly important and commonplace. VBCs also have important implications for Government Pricing programs. Therefore, life sciences companies need to take a coordinated and collaborative approach towards compliance that involves multiple stakeholders to evaluate the agreements and the potential impact on Government Pricing.


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October

2016

Getting to the Hub of the Matter – Analyzing the Compliance Needs for Hub Services

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Tom Gregory, Partner, Fraud Investigation & Dispute Services, Ernst & Young LLP

Within the pharmaceutical industry there are new operating models emerging. One form of emerging arrangement is the increasing use of “hub services.” This article explores the breadth and variety of hub services and arrangements and the many challenges in ensuring appropriate compliance oversight created.


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