Life Science Compliance Update

April

2018

The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder

Written by , Posted in Uncategorized

Nicodemo Fiorentino, Esq. and Seth B. Whitelaw, J.D., LL.M., S.J.D.

Drug pricing transparency, as a concept at least, is here to stay. However, the details of what that means and the new obligations that pharmaceutical companies will need to deal with are yet to be determined. For pharmaceutical compliance professionals, 2018 will continue to be a time of high uncertainty and an ever-increasing workload. This article examines the current state and what the future may hold.


   or   

Topic tags:

November

2017

Coming Soon to a State or Even City Near You – Part 2 Spend Disclosure & Much More

Written by , Posted in Uncategorized

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

In 2017, the pharmaceutical industry has been hit hard by the increasing number jurisdictions proposing, passing, and implementing numerous compliance requirements ranging from annually reporting payments and other transfers of a value provided to health care professionals, listing or licensing sales representatives and other employees, being prohibited from offering certain discounts, and facing “gift” limitations and restrictions. These jurisdictions include the City of Chicago (representative licensure and disclosure), Nevada (representative listing and disclosure), California (discount prohibition), Maine (“gift” limitations and restrictions), and New Jersey (proposed regulation to limit and cap meals and restrict consulting agreements). With another major election year ahead of the industry, the pharmaceutical industry will be an easy target. In fact, states will use the success of the previous year, combined with the pricing debate and the opioid crisis, to push through legislation and regulations.


   or   

Topic tags:

November

2017

Transparency Perhaps a Falling Star in the U.S. But Rising Internationally

Written by , Posted in Uncategorized

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

While interest in transparency seems to be waning in the U.S., it continues to rise internationally with Canada and South Korea. This article will examine the latest numbers from U.S. Open Payments and the efforts of Canada and South Korea.


   or   


October

2017

Coming Soon to a State or Even City Near You – Part 1 Pricing Transparency

Written by , Posted in Uncategorized

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

As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities, are stepping in to regulate pharmaceutical companies. This is the first in a two-part series focusing on the notable proposed state and city actions and laws and ordinances that have been or soon will be enacted in 2017. The article will focus on drug pricing transparency disclosure legislation that is being introduced at an ever-increasing rate. The pharmaceutical industry cannot fight each and every state and city action successfully. The truth of the matter is that the industry is losing ground and leadership within companies cannot begin to sacrifice their compliance and legal departments.


   or   

Topic tags:

July

2017

The California Hurdle – SB 790 and Pharma

Written by , Posted in Transparency

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.


   or   

Topic tags:

June

2017

Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?

Written by , Posted in Transparency

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

Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.


   or   

Topic tags:

September

2016

September

2016

State of the European Union – Transparency in Europe 2016 and Beyond

Written by , Posted in Transparency

Geert van Gansewinkel, Partner and Managing Director, Polaris Europe

Three years ago, EFPIA adopted the EFPIA transparency code. Now three years later, this article takes the opportunity to look at what has happened so far with transparency reporting in Europe and what the future may hold.


   or   

Topic tags:

September

2016

Pharma & Medtech – Like Chalk & Cheese?

Written by , Posted in Transparency

Nick Merryfield and Andrew Wiles of WorldDataOnline LLC.

The pharmaceutical and medical technology industries appear to show marked transfer of value variations in this year’s Open Payments data. This study investigates further and asks, is it a case of two sectors using unique commercial models, or a simple case of different reporting methodologies?


   or   

Topic tags:

August

2016

Transparency Across the Pond – A Look at Efforts in Germany and the UK

Written by , Posted in Transparency

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

On June 30, 2016, transparency efforts around the world released numbers on financial interactions between industry and physicians. This article goes through recent releases in Germany and the United Kingdom, including analysis on where the money is coming from, and who it is going to.


   or   

Topic tags:

August

2016

Caveat User, Caveat Emptor – Issues from the Soft Under Belly of The CMS Data Sets

Written by , Posted in Transparency

Mark Labovitz, Ph.D., MS, MBA, Principal, Attest Open-Payments™ and President, Data Analysis Consulting (DAC), LLC.

While the goal of Open Payments and transparency are arguably good public policy, the usefulness of Open Payments depends entirely on the quality of the underlying data. This paper explores some of challenges found in the 2015 data set that negatively impact that usefulness.


   or   

Topic tags:

June

2016

Detecting the “Sham” in Speaker Programs

Written by , Posted in Transparency

Mark Labovitz, Ph.D., MBA and Jeffrey DiFrancesco, M.Sci., M.Eng., Principals, Attest Open-PaymentsTM

This paper explores whether the publically available Open Payments data can be employed, using the same factual basis as the Government in its March 2016 allegations against Novartis to detect potential “sham” speaker programs.


   or   

Topic tags:

April

2016

Sun Glare- The Confusing World of the Physician Payment Sunshine Act and Biomedical Research

Written by , Posted in Transparency

Thomas Sullivan, BS, President Rockpointe Corporation

As part of the Affordable Care Act, the Physician Payment Sunshine Act tracks payments and transfers of value from manufacturers of drugs, devices, biologics, and medical supplies (applicable manufacturers) to physicians and teaching hospitals. This article explores which data are tracked and what this tracking means for research, including what researchers should do to ensure that their data are accurately reported and how to handle questions that may arise from the publication of the data. Results for the first two reporting cycles (5 months 2013, and 12 months in 2014) are highlighted.


   or   

Topic tags:

February

2016

Parting the Clouds – Some Thoughts on Why CMS Has Not Imposed Civil Monetary Penalties for Sunshine Act Violations

Written by , Posted in Transparency

By: Timothy M. Moore, Esq., Attorney with Shook, Hardy & Bacon L.L.P

Although the Sunshine Act allows for the imposition of Civil Monetary Penalties, CMS has yet to bring a single action. This article reviews the rocky implementation of the Sunshine Act and explores possible reasons for the lack of enforcement actions.


   or   

Topic tags:

January

2016

Global Transparency Trend: Lessons Learned from Sunshine shining on EFPIA

Written by , Posted in Transparency

By: Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Presently, both the U.S. and France have enacted legislation requiring various degrees of disclosure about payments made by life sciences companies to Healthcare Professionals. Beginning in 2016, EFPIA will be added to the mix. This article explores some of the similarities and differences between the U.S., France and EFPIA requirements. In addition, this article discusses some ways to prepare for and potentially improve global transparency.


   or   

Topic tags:

Gravityscan Badge
Menu Title