Life Science Compliance Update



July 2017: Life Science Compliance Update

Written by , Posted in July 2017 LSC Update, This Month in Compliance

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July 2017 LSCU Cover

Issue Summary

For the July issue, we have focused compliance program effectiveness. Our feature this month explores compliance resourcing challenges for small to mid-sized pharmaceutical companies. We follow this up with a detailed review of the new DOJ and OIG guidance documents. We also take a hard look at project pricing and how the current legal and regulatory structure may impinge on efforts to reduce costs. Finally, we take a look at the latest developments in transparency and false claims enforcement.



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

Compliance Operations


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



The California Hurdle – SB 790 and Pharma
Jenny McVey, Life Sciences Manager, FRA

Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems as though others are following suit. The California state Senate passed SB 790 in May 2017, a bill restricting pharmaceutical companies from giving gifts and incentives to medical professionals. This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.



LSCU SPECIAL FEATURE: Into the Nexus – Anti-Kickback Statute (“AKS”) versus Value-Driven Health Care

As health care reform continues to be a hot topic, there is discussion occurring regarding whether regulatory and compliance laws such as the Anti-Kickback Statute (“AKS”) are antiquated, outdated, and also require modernization, with a focus on improving patient outcomes and reducing overall healthcare costs. As such, the premise remains that the current legal framework is not necessarily compatible with transforming the health care delivery system, and needs to be revamped while still serving to provide substantive protections against fraud and abuse. This two-part series explores the landscape and recent developments in this area.

Part 1: An Uncertain Future in a Dynamic Landscape
By Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

Part 2: The Tension Increases – Online Auctions Violate the AKS
By Calisha D. Myers, Esq., Staff Writer and Dr. Seth B. Whitelaw, Editor, Life Science Compliance Update

False Claims


Pharmaceutical and Device Manufacturers: Buyer Seller Beware
John Kelly, Matt Curley and Rob Platt

Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as well as whistleblowers seeking large payouts for disclosing potential wrongdoing. There are a number of risk areas (some new, some not-so-new) that provide the basis for the government and relators to pursue alleged violations of the False Claims Act liability. Some of those areas are discussed below.


Punting on the Issue of FCA and Statistical Sampling
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether the government has veto power over False Claims Act (FCA) settlements, particularly where liability is established by use of statistical sampling, opted to forego rendering a decision on such issue, and leaving wide open the use and appropriateness of statistical sampling in FCA related cases

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