editor’s perspective

Regulation and Future Impact on Innovation

BY JASON J. NICHOLS, OD, MPH, PHD, FAAO

In my April 2012 Editor’s Perspective, I suggested in part that the U.S. Food and Drug Administration (FDA) needed to act more expeditiously on several issues facing the industry. I’d like to note that in 2009, the FDA was in the process of making changes and updating guidance—a process that was started three years prior. By the time January 2013 had come, we had indeed seen significant progress, with the FDA publishing several original research papers and editorials about these forthcoming changes in Eye and Contact Lens. As such, we named the FDA’s progress in 2012 our Contact Lens Event of 2012.

With all of that being said, I think it is also important to consider the flip side of the coin on this issue—that is, those who will be first impacted by these forthcoming changes. In this instance, I am referring to “the industry.” I recently ran across a research report that addresses this issue titled “Executive Perspectives on Top Risks for 2013,” by Protiviti Inc and North Carolina State University’s ERM Initiative. The report discusses a recent survey of more than 200 leaders (e.g., executives, directors, presidents) in large corporations regarding their concerns associated with macroeconomic risk issues (e.g., economic conditions, political leadership impact on markets), operational risk issues (e.g., ability to attract and retain talent, cyber threats), and strategic risk issues (e.g., acquisition-based growth, competitive entries into market).

The report was rich in data and insight, but what stood out among the results was that the responding business executives rated their overall highest area of concern as “the potential for regulatory changes to heighten regulatory scrutiny that will affect how products and services will be produced and delivered.” In fact, this was rated as having the potential for a “significant impact” and, according to the report, was rated as such “across most industries, all types and sizes of organizations, and most types of respondents.”

There is little doubt that regulatory changes associated with contact lenses and care solutions are intended to be beneficial, with the ultimate intention of many to improve the safety of our patients. Yet, let’s not forget about their potential impact on industry in terms of its ability to bring new and novel innovations to the market—something that we also need to optimally care for our patients.