As a Consequence: Trending Transparency, Technology & Esoterica

As a Consequence: Trending Transparency, Technology & Esoterica

By Charlene E. Davis, Associate Vice President & Head of Healthcare Compliance, Sun Pharmaceutical Industries

Charlene E. Davis, Associate Vice President & Head of Healthcare Compliance, Sun Pharmaceutical Industries

It follows as a consequence that much innovation observed today resulted from situational factors pushing us to do more beyond our current limitations. What was once enough to enable progress becomes obsolete or challenged by the notion of new requirements, newer ideas, and the newest…thing…and so a shift occurs. Following the shift of change in some instances is an abstract compulsion which goes unappreciated by most. We can all think of examples where it simply resulted that one day we were no longer doing the thing we once did because the standard had changed. How one progressed from the old to the new happened almost unremarkably and we found ourselves in that new place doing that new thing not quite remembering how we got there – like the use of mobile phones, Facebook, or online banking.

Perhaps it is a stretch of the imagination to ponder why some change occurs this way, i.e., seamlessly. One thing becomes the new thing unnoticeably like 2 plus 2 equaling 4. It makes sense; it works; it’s balanced and is not an affront to natural law, right? We see this in physics. Albert Einstein illustrated the same seamless conversion in his theory of special relativity, E=mc2. Einstein simply stated that Energy is the same “thing” as Mass multiplied by the Speed of Light squared. Neither is different and like 2 plus 2 equaling 4, Einstein’s elements – Energy, Mass and the Speed of Light – can be balanced. In both simple math and Einstein’s theory, there is interchangeable harmony making it easy to become the new thing or to change.

"The proliferation of transparency regulations for pharmaceutical companies illustrates an interesting observation in change"

However, there are occasions when becoming the new thing is not seamless; when we cannot seem to fully achieve the outcome the situational factors are pushing us to become. We have seen this where companies have collapsed because they were unable to adapt to the changing landscape. Something was missing from the equation that prevented 2 from becoming 4 or Mass from equaling Energy.

While the changing landscape of corporate compliance is arguably not as intriguing as that of physics, the proliferation of transparency regulations for pharmaceutical companies illustrates an interesting observation in change. Currently, transparency rules are surfacing in varying forms at various levels of government. Federal, state, and local government agencies are requiring new obligations and compliance officers must adapt to sustain. Somehow compliance officers must find the additive or multiplier to enable them to meet with equal reciprocity the new standard and find harmony and continuity. Interesting is technology’s indelible role in assisting with the change that must be made to meet the new requirements.

At a quick glance, the initial provocation for change began with the burden of Federal transparency laws. Across the country, compliance professionals were scratching their heads scrutinizing ACA 6004 and 6002 trying to determine what was required. Simultaneously, industry specialists were cobbling together small firms to offer technological and consultative solutions to make plain the complex. The new standard not only demanded insight into aspects of the companies compliance officers supported but also operational and analytical acumen that might not have previously existed within their compliance programs.

The new ask created debate and commentary as perceivably a divide existed between what was being demanded and what could be accomplished. For many, the text of the rules did not get “it” and now companies had to pull “it” together. Yet, pulling “it” together was the challenge; the shift was neither seamless nor unremarkable. Rather, the masses needed assistance in reaching the desired outcome. For most, the development of technology in the form of various aggregate spend systems was the missing component to enable the conversion. Technology enabled compliance and it provided speed – perhaps not at that of Light but with sufficiency the masses could appreciate.

Yet with that advancement, in short order, state transparency regulations developed similar disclosures. New Jersey, Nevada, Ohio, and others weighed in wanting a piece of the action. Rules such as N.J.A.C. 13:45j et seq., which placed limitations on prescriber compensation, and Ohio’s Terminal Distributor of Dangerous Drugs regulation, which evolved to require licensure verification for the distribution of prescription drug samples, created a new layer of discrete demands adding complexity to the already strained program. Despite these new requirements, compliance teams sought adaptation by leveraging again the same technology which brought them through the first time.

Change continued with localities like Chicago creating another level of transparency through its licensure ordinance, Municipal Code 4-6-310 et seq., which Nevada’s N.R.S. 439B.660 regulation and proposed New Jersey Assembly Bill 3950 follow. Yet again, new all-encompassing technology did not develop. Consequently, with the accumulation of rules, compliance risks emerge.

For compliance programs, becoming the new thing has not been seamless. There is a struggle in responding to the momentum of transparency regulation. The additive to enable 2 to become 4 or Mass to equal Energy is missing or lagging. The masses are unable to respond with the efficiency required without the multiplier technology can supply. Today, compliance programs leverage momentary technology which meets historical demands but lacks foresight and, thus, is not extensible. As a consequence, while lawmakers draft and firms extend new consultative offerings, the real innovation has yet to evolve and balance the landscape.

Read Also

IT Services at the FDA

IT Services at the FDA

Todd Simpson, CIO, FDA
The Challenge of Complex Biologics Development

The Challenge of Complex Biologics Development

Ron Guido, VP, Regulatory Affairs, IRX Therapeutics
Pro-Active EHR Optimization is a Necessity

Pro-Active EHR Optimization is a Necessity

Toni Jarrett, Executive Director, Advisory Services, Optimum Healthcare IT
Top 10 Drug Discovery and Development Solution Providers - 2018
Top 10 Drug Discovery and Development Consulting/Services Companies - 2018

Drug Discovery and Development Special