Life Science Compliance Update

September

2018

Where Is the Grass Greener? Banking or Life Science Compliance Part II

Written by , Posted in Uncategorized

By: Jenny McVey, Ph.D.

In the August issue of the Update, we discussed key regulatory mandates that large banks are expected to adhere to. Although the overall principles of banking compliance mirror that of the life science industry, there is a concerted emphasis around the engagement, responsibility, and accountability of a bank’s Board of Directors, which is unseen within life sciences. This article discusses how large banks operationalize regulatory mandates by reviewing the organizational structure of a compliance function within a bank.


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  • August

    2017

    The Fine Art of Policy Management

    Written by , Posted in Compliance operations, Uncategorized

    Matt Kelly, Editor & CEO at Radical Compliance

    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.


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    August

    2017

    Independent Review Organizations (“IRO”) and Conflicts of Interest – Much Ado About Nothing or a Serious Problem

    Written by , Posted in Compliance operations

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

    As part of the process of entering into civil and criminal settlement negotiations with the government resulting from allegations of noncompliance, life science companies are increasingly seeking the retention of third-party regulatory compliance and auditing companies, designated collectively as independent review organizations (“IROs”) to facilitate such process. Recently, there is renewed skepticism and heightened criticism over the companies’ use of such IROs, especially given revelations that companies are choosing IROs that they may have had business relationships with in the past or present. Despite this, the U.S. Department of Justice (“DOJ”) and other government oversight agencies argue that the current status quo is effectively working, including the already established standards, qualifications, and other guidelines for the selection of an IRO. This article examines the various view points and what it means for the life science compliance professional.


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    July

    2017

    Effectiveness, The Holy Grail of Compliance – Both the DOJ & OIG Weigh In

    Written by , Posted in Compliance operations

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

    Measuring the effectiveness of compliance programs is no easy task since governing agencies have not published a template that will work in all cases; compliance measurements are unique to each company’s size, operations, resources and risks factors. Although there is no “one size fits all” program, both the DOJ and the OIG (in conjunction with the Health Care Compliance Association (“HCCA”)) recently issued guidelines and recommendations for healthcare organizations to design, implement, evaluate and improve their compliance programs. Unfortunately, this may have been done in a vacuum as neither agency appeared to have consulted with one another. There are similarities, differences, and ambiguities between the two agencies’ point of views. This article serves to compare and contrast the compliance guidelines as set forth by the DOJ and OIG within weeks of each other.


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    May

    2017

    Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk

    Written by , Posted in Compliance operations

    Lauren Barnett, Senior Compliance Content Specialist and Sean Murphy, Product and Marketing Manager, PharmaCertifyTM by NXLevel Solutions

    Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a growing milieu of subject matter, from off-label promotion, HIPAA, and data security, to anti-bribery laws around the globe. The rush to cover all the topics across all the potential audiences can lead to a convoluted curriculum, with gaps or redundancies in terms of which audiences receive what training. Building a curriculum that appropriately addresses the company’s unique risks is an important first step, but a regularly-scheduled analysis of all content, and audiences and delivery methods, is critical to ensure on-going effectiveness against risk.


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    March

    2017

    Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?

    Written by , Posted in Compliance operations

    Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)

    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 second in the two-part series.


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    March

    2017

    Accountability: The shifting landscape of compliance responsibilities

    Written by , Posted in Compliance operations

    Darren Jones, Managing Partner, Polaris Management Partners

    The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.


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    February

    2017

    Product Price Hikes – When Business and Compliance Collide

    Written by , Posted in Compliance operations

    Mark Scallon, Partner, FRA Life Sciences and Derek Patterson, Principal, FRA

    2016 was the year of the price increase, as leading industry players experienced significant public outrage over what appeared to be extreme price increases. What is compliance’s role when it comes to price increases? Does the ethics and compliance function get to weigh in on how decisions to raise the prices of products are reached, or does this function lie solely with the business? This article explores those questions.


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    January

    2017

    Maintaining Independence & Objectivity – OIG Releases New IRO Guidance

    Written by , Posted in Compliance operations

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

    The Health and Human Services Office of Inspector General has released new guidance on an important topic, Independent Review Organizations within Corporate Integrity Agreements. This article goes through the recent guidance and explains the requirements of objectivity and independence. The conclusion also provides several practical takeaways from the new guidelines.


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    December

    2016

    Has Integrity Become a Commodity? – Warning Signs of Bad Behavior for Compliance Professionals

    Written by , Posted in Compliance operations

    James Bone

    This article takes a fresh look at trends in changing norms of ethical behavior by senior management and the challenge for compliance officers to recognize and address these changes at the enterprise level. A body of research is beginning to emerge to help inform compliance officers of new approaches to identify and address the threat of deteriorating ethical behavior before damage is done. A review of research in behavioral science points to examples of predictable outcomes where certain conditions create incentives for a change in ethical outcomes.


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    December

    2016

    Medical Affairs and Marketing: The Evolving Role of the Compliance Officer

    Written by , Posted in Compliance operations

    Ronald G. Walls, M.D., Walls Strategic Consultants

    Historically, medical affairs and marketing have directed both the generation and dissemination of information about their products. Digital technologies have weakened that control, opening an array of new, independent information channels. This article explores the unprecedented and unmet need for industry to have their compliance officers be trained to be as social media compliance officers.


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    December

    2016

    The Seventeenth Annual PCC: Day 2 Highlights

    Written by , Posted in Compliance operations

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

    This article is a continuation of the previous article that discussed the first day of the 17th Annual Pharmaceutical and Medical Device Compliance Congress. This article covers the highlights from Day 2 of the conference.


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    November

    2016

    Retaliation, Pre-taliation, and Whistleblower Hotlines: How Compliance Officers Can Fight the Biggest Challenge They Face

    Written by , Posted in Compliance operations

    Matt Kelly, Editor & CEO at Radical Compliance

    Handling whistleblowers is one of the biggest challenges facing most compliance officers. Furthermore, recent actions taken by the SEC are de facto policy pronouncements expanding the range of whistleblower risks compliance officers face. This article will review the three primary concerns that compliance officers have about whistleblowers: how to stop retaliation; how to avoid pre-taliation; and how to design whistleblower hotlines.


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    October

    2016

    The Dilemma of Co-Pay Charities and Patient Access to Medication

    Written by , Posted in Compliance operations

    Lenna M. Babigian, M.H.S., Paralegal, LCSU Staff Writer

    Increasingly creative methods are being used by big pharma to increase sales. Drug manufacturers are donating billions of dollars to not-for-profit organizations that fund co-pay assistance programs for patients. Pharmaceutical company profits are through the roof and these not-for-profit organizations are growing at incredible rates. Even though patients are receiving much-needed financial help, there is an abundance of legal and ethical concerns.


    October

    2016

    Like Taxes and Inflation – HHS Revises Civil Monetary Penalties Upwards

    Written by , Posted in Compliance operations

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

    The Department of Health and Human Services has issued an Interim Final Rule, adjusting for inflation the maximum civil monetary penalty amounts for various civil monetary penalty authorities within HHS. This article elaborates on the increases, as well as what they may mean for the future of compliance.


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