For the last eight years, I’ve built a career around the belief that the work I do every day helps people. As a medtech communications specialist who helps raise awareness about new innovations, the best part of my day is knowing that I’ve educated someone (or their loved ones) about a treatment option that could better manage their disease – and hopefully improve their lives.
So, naturally, I was drawn to understand the plans set out by FDA commissioner Scott Gottlieb in his blog post about how the organization will implement The 21st Century Cures Act. His blog cites examples for an actionable work plan that will “modernize” the current state of regulatory programs to “facilitate access to safe and effective new innovation.”
I obviously agree that getting treatments into the hands of those that need them most is paramount. However, the following “Cures” provision prompted me to stop and think about what’s most important when it comes to patient access to medical innovation:
Under provisions of Cures, CDRH exempted more than 70 Class I device types from the requirement to submit to FDA a 510(k) submission. CDRH also proposed exempting another 1,000+ Class II device types from having to submit a 510(k) submission based on an initial determination that premarket review is not necessary to provide a reasonable assurance of safety and effectiveness. This action will decrease regulatory burdens on the device industry and eliminate private costs and expenditures.
The last sentence struck me most and brings me to my core question: how can we best balance the scale? How can unnecessary regulatory burdens be eliminated, but at the same time, how can we ensure that rigorous trials and supportive evidence continues to be produced? How do we ensure that new, FDA-approved innovation truly improves patient outcomes, and are worth the money? This conundrum is at the heart of the future of the medical device industry.
Last year, a device that had promise to revolutionize the minimally-invasive treatment of coronary artery disease was approved by the FDA. Then, earlier this month, the device was pulled from the market due concerns that it resulted in a significant increase in cardiac events after implantation.
A regulatory action of this kind is not unique. In fact, it’s been happening for many years – a Perspective piece[i] in the New England Journal of Medicine that was published in September 2011 cited a different example, with authors concluding: “…in the interest of advancing human health, patients must have easy access to innovative medical devices and…the approval process needs to be sensible and efficient. But no one’s interest is served by putting defective medical devices onto the market where they cause harm to patients, waste health care dollars, and may kill jobs when they are withdrawn.”
These words were published six years ago. And yet here we are, still grappling with the same issues.
In the end, the solution lies in achieving the right balance: fewer regulatory barriers vs. more clinical scrutiny. We must continue to drive innovation forward to help save lives, but we can’t put too much weight into fast-tracking approvals without the appropriate clinical rigor that provides insight into a technology’s long-term potential.
So, which side do you think should tip the scale?
[i] Curfman, G. D. & Redberg, R. F. (2011). Medical Devices — Balancing Regulation and Innovation. N Engl J Med. 365:975-977. DOI: 10.1056.