An open letter to Margaret Hamburg and Jeffrey Shuren wonders whether the medtech industry is a resolute warrior or an idealistic fool in the quest for collaboration with FDA.
By Mark DuVal, DuVal & Associates, P.A.
Despite industry’s current focus on the negative impact of the medical device tax, that policy issue pales in comparison to more-foundational problems with FDA. The agency poses an escalating threat to industry through its inconsistent interpretations of regulations and guidance documents; delays and inability to make decisions; general risk averseness; increasing and unreasonable expectations for data; and desire to regulate every aspect of the development, study, manufacture, and commercialization of medical devices.
So, in the survivalist quest to bring a medical device to market in this challenging regulatory environment: Is the medical device industry more like Scottish warrior William Wallace, the real-life inspiration for Braveheart who fought passionately for freedom from oppression, or are we the delusional Don Quixote and just dreaming the impossible dream?
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The Warrior or the Idealist?
Leaving begind a legacy of remarkable words and deeds, William Wallace was a 13th-century Scottish warrior who, in 1280, led the Scots in the First War of Scottish Independence against King Edward I "Longshanks" of England. Of course, he gained modern-day fame when depicted by Mel Gibson in the acclaimed movie Braveheart. Like William Wallace, our firm and others in the medical device industry hold onto the belief that we can make a difference—that our actions will make the government sit up, take notice, and adjust. So, we bravely fight on with resolve and a principled purpose.
Although we favor perceiving ourselves as the inspirational hero fighting oppression, we question whether we’re actually more like the idealistic and oblivious Don Quixote. Have we romanticized our future with the agency? Are our hopes for common ground and collaboration an illusion, partly of our own making and partly due to the deception of the government itself?
An Issue of Institutional Intransigence
On the surface, FDA smiles more, is friendlier, and appears more cooperative than in the past. But procedurally, the agency is no faster. It has not substantitvely improved, it lacks consistency, and it rarely compromises.
Throughout various junctures of the approval and clearance process, FDA leads the medical device industry to believe that it understands and agrees with the scientific arguments presented, only to relentlessly and stubbornly cling to the amount of data FDA in its infinite wisdom feels it needs. Worse yet, the agency later repudiates points it has previously agreed upon. FDA also entertains our ideas and comments when we respond to the endless stream of new regulatory (transparency) initiatives, only to mostly ignore them in the end. Constant reinterpretations and new interpretations of law, regulations, and guidance further frustrate industry and muddy the waters.
Ultimately, FDA has a view of scientific dialogue with industry that is profoundly unscientific and is essentially tantamount to declaring, “it’s my way or the highway.” Former FDA Chief Counsel Nancy Buc spoke to this point at the Fourth Annual Regulatory and Compliance Symposium in 2009.
“It would help greatly if first-line and higher levels of decisionmakers were all equally willing to engage seriously with sponsors who have views about the science, the applicable law, or both. I have been to many a meeting at which the working assumption seemed to be that sponsors should simply do what FDA told them to do. That isn’t good science, it isn’t good law, it isn’t good policy, FDA shouldn’t do it, and sponsors shouldn’t acquiesce in it…I have sometimes said to FDA people that an industry person is not wrong just because he or she is in industry any more than an FDA person is right just because he or she is at FDA.”
In many cases, the medical device industry has collaborated with the agency to obtain reasonable compromises. These compromises are often only obtained with the involvement of upper management, however, as they are experienced enough to know the boundaries of the law and regulations, and seem to consider the long-term consequences of a crushing regulatory environment upon the industry it regulates. Unfortunately, the work of the agency is done primarily in the trenches where these good upper-management intentions never seem to take root and effect actual change.
An Agency of Change
Part of the problem is that the trenches at FDA have undergone dramatic change in recent years. Many FDA reviewers now boast a PhD or other advanced degree—not a bad thing, but it has certain consequences. They are specialists, not generalists, and are motivated to ask endless questions, whether or not they have any pragmatic bearing on a product review.
Because of these impossibly high standards, these specialists find the data are never correct or sufficient, regardless of the quality and quantity of the data submitted by a PMA or 510(k) applicant. FDA reviewers frequently ask for data that is wanted—not needed—to make a PMA or Substantially Equivalent (SE) determination. These escalating data requirements are not borne out of scientific need and least burdensome requirements. Rather, they are products of a lack of experience, risk averseness, fear of bogeymen, control issues, and the desire to make the unattainable perfect regulatory decision.
Rarely do we see in the agency the courage to help new technology get approved without legions of data. Consequently, the largest medical device companies—and smaller ones, too—report that a declining percentage of industry dollars are spent in actual R&D because they are being diverted to fund the increasing demand for clinical trials and additional animal data from FDA, many of which are overkill. Likewise, funding has suffered as venture capitalists and angel investors perceive FDA requirements as too uncertain or unreasonable.
Compounding the issue is the agency’s shifting focus to academic pursuits instead of doing the blocking and tackling of a regulatory agency. FDA loves to talk about the development of “regulatory science” as if it will solve all of our problems, not compound them. But FDA knows that if it waives the banner of patient safety, it can get away with virtually any new program it wants to explore or new requirements it imposes upon industry because Congress is ill-equipped to second-guess it and has little political will to do so.
Truly, FDA in the last five years is more of an academic institution than it has ever been—and that’s not a compliment. The agency needs to apply current science, not create it. It needs to approve and clear devices, not invent tests to develop them. This is huge mission creep and beyond the scope of its regulatory authority.
What FDA really needs is a big dose of common sense. We are waiting with great anticipation to see whether the Medical Device Innovation Consortium (MDIC) initiative—a public/private joint venture to develop regulatory science—helps industry or adds to its regulatory burden.
Fighting the Good Fight
So, with these challenges in mind, are our efforts futile? Are we tilting at windmills in our belief that we are actually fighting a dragon? Or are these battles with FDA real, sound, and worthwhile? Is harmony and scientific compromise a fleeting mirage with this agency, always off in the distance but never reached?
It certainly feels as if that’s the case most days. FDA continues to dismiss or ignore criticisms and survey findings from the medical device industry, despite a remarkable consistency in feedback and recurring themes. In April 2010, our firm took the steering committee of the Minnesota Medical Device Alliance to meet with Dr. Shuren to share with him how FDA’s policies were affecting innovation and investment in innovation. We had high hopes for the Hamburg/Shuren Administration back then. The same can’t be said today.
But, like William Wallace, we continue to fight what we believe is a noble battle. The medical device industry has participated in endless policy discussions, ranging from town halls on the 510(k) program to innumerable FDA “transparency initiatives, ” to legislatively defeating FDA’s proposed 510(k) modifications guidance and adding performance requirements in the user fee legislation. We’ve worked exhaustively with politicians to provide insight into the damage caused by the agency’s operations and urged them to speak up on industry’s behalf. We and likeminded industry members have publicly condemned the agency’s actions from the podium and in trade publications in an effort to effect change. And in January, our firm even filed a Citizen Petition on behalf of the MedTech Resource Alliance and the Minnesota Medical Device Alliance.
Our industry is fatigued with battling this agency, however. It continuously grows and rarely, if ever, falters or concedes. It has an institutional sort of arrogance born mostly out of positional strength and not always intellect or ideas.
And what’s at stake is not insignificant: improved patient outcomes and state-of-the-art healthcare. FDA, whether intentional or not, stifles innovation and delays the commercialization of devices that improve healthcare. As a result, we are noticeably falling well behind the rest of the developed world.
American medical device manufacturers continue to invent most of the world’s innovative medical technologies, yet our patients are the last among the industrialized world to have access to them. Devices are often approved and on the market in Europe and elsewhere a staggering four to five years before the United States. In turn, U.S. physicians have expressed concern that they are falling behind in their skill set compared with overseas colleagues.
Yet FDA’s solution to this comment is not to accept the challenge to get better and faster, but to participate on international harmonization committees with other countries to ensure they slow down and emulate FDA’s overly cautious approach. Of course, this infuence is best exemplified by what is happening with the new European Medical Device Directive.
Where Do We Go From Here?
At its core, FDA is full of good people trying to do good things. But, as is often the case with any bureaucracy, it has, over time, lost sight of its overall mission. FDA now views itself as having the ability and mission to develop medical devices and develop once-size-fits-all testing standards in conjunction with universities. The agency seemingly also wants to be in the role of medical device management, remotely running companies from Silver Spring, Maryland, as its policies attempt to dictate industry behavior from product conception and testing to manufacture, modification, and commercialization.
Moreover, the balance in joint responsibility between self-regulation and FDA regulation is severely tilted in favor of more complex, expensive, and stifling FDA regulation. This is where the agency truly becomes The Fourth Estate, writing guidance documents inconsistent with the law that were never contemplated by Congress, and wielding more power over us than the elected or judicial branches. FDA’s interpretations of the law go unchecked, as does its ever-expanding authority.
As we and our medtech allies fight this uphill battle, we won’t definitely know whether we’re the courageous William Wallace or the foolish Don Quixote until we see how FDA reacts to calls for regulatory reform. The hope is that the agency responds not with more smiles and a seemingly cooperative attitude, but with realistic expectations, proper application of standards, and compromise. But to get there, it takes internal FDA leadership and a desire to inculcate real change within the FDA’s culture, not just aspire to it from the podium.
Will it happen with this administration before it’s too late for an already-declining industry? We don’t know. But we do know that this industry and what it creates for patients is worth fighting for.
|Learn more about the industry's challenging relationship with FDA and weigh in on whether industry is dreaming the impossible dream or fighting the good fight with FDA at the MD&M West Conference February 10-13, 2014, in Anaheim, CA.|
Mark DuVal, J.D., is president of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training, and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, and appeals.
[Braveheart image courtesy Paramount Pictures]