"Unpredictable, inefficient and expensive regulatory processes are jeopardizing America's leadership position in Medtech innovation."
One of our bloggers posted a question regarding the pro's and con's of the FDA, and whether it encourages, or discourages, innovation in the medical technology sector. Obviously, the pernicious social and political environment that currently exists in this country plays an important role in any dialogue that may be expressed regarding any government agency. In all likelihood, this question was probably posed because of a recent report that was published in November by Josh Makower, MD, a consulting professor at Stanford and the CEO of ExploraMed Development, LLC, Venture Partner, NEA. The study focused exclusively on the pre-market regulatory process, surveying 204 companies which make up 20% of venture backed medical device companies that are attempting to bring innovative technologies to the market in hopes of improving patients lives. The participants were asked about their experience working with the FDA, as well as working with their counterpart in Europe. But before we get into the MDM, let's give the FDA their due process considering that many people probably don't even know what the FDA really does. To summarize;
The FDA is responsible for protecting the public health by assuring safety, efficacy and security of human drugs, biological devices, medical devices, our food supply, and products that emit radiation. I'll spare you the vetinary and cosmetic part. Their role is to help advance the publics health by helping SPEED INNOVATIONS THAT MAKE MEDICINE MORE EFFECTIVE, SAFER, AND MORE AFFORDABLE and by helping the public get the accurate science based information they need to use medicines and foods to maintain and improve our health. When it comes down to the spine industry their perfunctory role is to regulate pre-market approval, oversee and monitor manufacturing performance standards and track medical device reports and adverse reactions. The November study contends that patients in the Europe are getting new therapies an average of two years before patients in the United States due to regulatory challenges. Why? It seems that the argument that is made is that our regulatory environment is adversely impacting innovation, which leads to impacting the quality of patient care and job creation. But why is this happening?
It seems that 44% of those survey complained that part-way through the pre-market regulatory process, they experience changes in key personnel, including the lead reviewer and or the branch chief responsible for the product's evaluation. 34% surveyed stated that integral decision makers were not present at meetings between the FDA and the company. Participants also voiced their concerns about the time that it took for a 510(k) approval, some claiming it took as long as ten months for low to moderate risk devices. In addition, for those who spoke with the FDA about conducting a clinical study on low to moderate risk devices before making a regulatory submission, the process took an average of 31 month as compared to 7 months in Europe. High risk devices too an average of 54 months in the U.S. as compared to 11 months in Europe. TSB is sure our readers can surmise that the FDA compared unfavorably to their European counterparts. There are many reasons why this is happening. But let's first let's take a view from thirty thousand feet and get a realistic perspective as to the process rather than just looking at the results. Considering that the POTUS just froze federal employees salaries and wages, the question must be asked, why is it so difficult to retain talented and knowledgeable people at the FDA? Based on TSB's experience, tenure is not an endearing trait of many examiners. No doubt that there are some veterans, but if you want bright lights and big dollars, its not happening at the FDA. Tenure and efficiency are not the FDA's better qualities. But there are other aspects to the process. By nature everyone believes that they dot their "i's" and cross their "t's." But if one is going to throw stones at the FDA, how about some of the people that are preparing the necessary documentation on behalf of some of these ventures. It seems that many people in corporate regulatory "tippy-toe" around this organization because they themselves are not efficient or they love creating the aura that its not nice to ask big brother questions or challenge their inefficiencies. It's a two-way street. But why has this become such an issue?
Money! Because on average cost for low to moderate risk 510(k) products from concept to clearance was approximately $31 million, with $24 million spent on FDA related activities. As investment capital is shrinking, these mounting costs are unsustainable. Therefore, companies are going OUS to develop emerging technologies. Of course, then the FDA becomes the culprit as to the ever escalating cost of delivering innovation in an ever escalating financial healthcare environment. The implications are tremendous. Regulators and innovators must find a better way of working together. But will this happen in an ever increasing obstructionist environment? The Republicans just spent two years blocking any attempt to pass legislation, whether one agrees with that political view or not, and now the Democrats will spend the next two years doing the same. But it's going to take a little more than just calling the FDA on the red carpet. It' going to take both sides coming to the table and making some serious concessions about the process, including companies evaluating whether the people responsible of carrying out the necessary documentation are capable themselves of efficiency. Only then, will we arrive at a workable medium. Think about some of the companies in our own industry that have either failed or are struggling with their submissions. The blame cannot be place entirely on one party, it takes two to tango, and you know what Charles O. Prince, and don't let me forget the "III" after his name said; "as long as the music is playing, you've got to get up and dance." TSB wants to know, is this really a one-way street, or is there traffic jam coming from both directions, you be the judge.