A study completed by the Boston Consulting Group points to a significant rise in the number of drugs and complex devices approved in the EU long before the United States. As devices get more complex, the United States is likely to fall further behind. Although the FDA does not issue clear data on backlogs or processing times, research points to shortcomings in our current system when it comes to researching and approving complex devices. This has broad implications for the quality of health care that Americans receive. In 2010, for example, the medical device company Biosensors International shut down its operations in California due to the time and expense associated with getting FDA approval for a cardiac stent. That device is available globally, including in Mexico and Canada.
She discusses a solution in which the FDA expands its pool of experts. I don’t think that this gets at the problem.
I am in investor in a company that is developing a new elective medical procedure which involves some upgrades in the capabilities of an existing and widely-used piece of technology. The company – which has extensive and international experience bringing similar projects to market – had put forward its best guess at a roadmap and timeline should things go as expected (with plenty of prudent slack for unexpected setbacks and delays), and I simply cannot get over the enormous gap in approval estimates between the U.S. and the rest of the world.
Apparently, the almost uniformly implemented best-practice is to plan for years of ‘medical tourism’ in which Americans interested in the service will be linked to foreign partners and practitioners – even in other other first world countries like Canada – and sold package deals including transportation and lodging, with U.S.-based medical professionals performing as much of the preliminary and follow-up care as legally permitted.
Of course, FDA. approval is still sought, and the huge compliance burden carried, because of the huge and nearly unique financial incentive that access to the domestic American market provides. After all, most people are reasonably very uncomfortable with the idea of having any medical procedure performed far away from where they live, which is of course a service which must be provided face-to-face, and so they are a kind of captive market.
I think this makes a certain case for an alternative explanation of the FDA’s outlier status relative to its most comparable international peer institutions. That is, for typical, well-understood reasons related to the incentives of bureaucratic institutions, the FDA will raise the cost of compliance to whatever the market will bear, and providers of medical goods and services will bear idiosyncratically enormous costs to have access to the American market, over which the FDA has a monopoly, because most American customers cannot or will not procure those goods and services overseas.
If this explanation is even partly right, then any effort – short of radically curtailing its power – to reform or gently tinker with the FDA, is doomed to failure and futility.