Black and white. Yes and no. On and off. Absolutes. Extremes. Exactly what our sensationalist media involuntarily expects each of us to believe is absolute truth. And, thankfully, wisdom typically prevails with the ever-present maxim “The truth lies somewhere in between.”

I was musing over this “extremist” mentality and found myself thinking about how even the FDA has fallen victim to this mentality.

Over the past year, the FDA has come under fire from a variety of sources– an article penned by Scott Gottlieb titled “How the FDA Could Cost You Your Life” suggests that the FDA is holding up key medical innovations that could greatly improve the health of Americans. Furthermore, the Institute of Medicine (IOM) issued a report in summer of 2011 stating that the 510(k) process is flawed. Investors are wary of life science startup companies because of the unpredictability of the approval process (as explained in yesterday’s post).

On the other hand, the FDA commissioner Margaret Hamburg wrote a piece in the Wall Street Journal hailing FDA as “America’s Innovation Agency” . Add to that, the government is pushing bills through congress to improve regulations. And, while user fees did rise in the Federal Drug Administration Safety and Innovation Act (FDASIA) passed this summer, industry lobbyists agreed that the return would be a more predictable regulatory path.

What, then, is the true story behind the FDA – Dr. Henry Jekyll, the well mannered doctor looking to ensure that the health of Americans is protected by creating an intuitive clearance path while fostering innovation, or Mr. Edward Hyde, the mysterious adversary to innovation who would single-handedly destroy all hope of allowing the United States to be a leader in medical devices?

Dr. Henry Jekyll, in his true, original state, represented a struggle of balancing the good and bad within himself. To release himself to a pure good state, Dr. Jekyll creates a potion to mask the bad within his personality, unintentionally causing his transformation into the dark and mysterious Mr. Edward Hyde. Ultimately, Mr. Hyde grows so strong that Dr. Jekyll relies on the potion to reduce the ill effects of Mr. Hyde’s existence.

The FDA’s analogous personalities reflect the dynamic between safety and efficacy versus innovation. The sensationalized protagonist is shown as the ultimate protector and a shining beacon of innovation, while the sensationalized antagonist appears as a controlling overlord, unwilling to promote innovation. When viewed with an objective, unbiased eye, the FDA strives for a balance of regulation and innovation, much like that of the original, younger Dr. Jekyll prior to the potion.

Manufacturers and developers will always have the hurdles, hoops, and obstacles to dodge in the process; it is the nature of a regulated industry and, for the safety of the public, it will always remain. On the other hand, the FDA is truly re-evaluating their processes to allow them to be more intuitive. Even President Obama has challenged the government to become more efficient, issuing an executive order inviting the government into the 21st century by stating that web access, mobile access, and other more modern communication solutions be implemented to increase government efficiency. In addition, RQS has experienced a more understanding, cooperative partner in the FDA with several of our recent clients. While still completing its mission to protect Americans, they also consider the improvement in care posed by new devices. Instead of closing every door, the FDA and developer devise a pathway that ensures safety and efficacy without the regulatory guessing game.

While there are slivers of truth in each and every story written on the FDA, the truth is that the FDA is working to protect Americans, foster innovations, and continue to improve. Rather than taking the side of Dr. Jekyll, or avoiding Mr. Hyde, I challenge companies to work with the FDA to achieve the proper balance needed.

-RTK

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