FCPA and Sunshine Act – Two Sides of the Same Coin

Some of the recent egregious examples of fraud and abuse in the pharmaceutical industry have created what many view as an increasingly hostile regulatory environment.  The record setting fines for marketing violations has crippled several companies and produced widespread angst in the industry.  If this isn’t enough, pharmaceutical companies will soon be required to report any payment to a health care provider and post this data on the internet for public scrutiny.  This demand for increased transparency will require companies to think more proactively about the best way to remain in compliance while also developing internal processes to avoid the negative exposure associated with a local or federal lawsuit for suspected impropriety.

As the looming August deadline for bio-pharmaceutical companies to begin publicly reporting payments to health care providers (HCPs) nears, debate about the best approach to developing comprehensive compliance programs will become as common as apple pie.  While we all agree clearly defined corporate goals and policies can avert a public relations nightmare, there is less agreement on how to best develop enduring technological processes that meet the strict standards being set by new legislation.  The bottom line is failure to comply can have extraordinary consequences as I’ve noted in the graphics in this blog post.

Having started my career in the pharmaceutical industry and later providing consulting services globally to this industry, I have an interesting perspective on the framework many companies adopt when it comes to gathering data for compliance tracking.  I was always amazed by the apparent lack of maturity of solutions in this space despite the astronomical costs to maintain such systems.  Remarkably, when companies think about compliance, they tend to think about specific reporting needs in silos.  This tendency to think about compliance in one dimension, in my view, is not only anti-intellectual but also works against the principle of innovation most companies purport striving towards. In all my years in the industry, I rarely heard anyone ask this basic question: “Is there a way to address all compliance reporting needs with one system?  Imagine the productivity gains from a compliance perspective companies would enjoy if such a framework were embraced.  That’s what I would call innovative thinking.

To gain more insight into my thinking on the topic of solving multiple compliance needs using a single platform, please read my white paper on the topic.  Some of the key highlights of this paper are:

  1. The Sunshine Act and FCPA are in reality two sides of the same coin and it is possible for a single process management system to address the reporting needs of each.
  2. It is possible to eliminate unnecessary waste associated with managing multiple systems while also improving data quality
  3. This new approach can decrease inconsistent standards in data across users and affiliates by automating processes with built in business rules
  4. User adoption and compliance can be improved by allowing access on any device, anytime, anywhere

James Pierce
Solutions Leader, Pharmaceuticals