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August 15, 2011
Originally published in Center of the American Experiment
Food and Drug Administration (FDA) rules are supposedly intended to ensure the safety and efficacy of new drugs and medical devices. It is FDA’s technology gatekeeper role—its power to approve or reject medical innovations in a one-size-fits-all fashion—that I would sacrifice willingly.
I seek the freedom to explore the medical frontier, to have access to experimental medicines and medical devices that the FDA has not approved, and to go out (as I’ll explain) as a hero.
I agree that taxes and government spending are out of control. These forms of government intervention are troubling, but at least they are receiving attention. Yet taxing and spending are relatively transparent compared to regulation, whose costs are off budget and whose impacts are diffused throughout the economy. Regulatory reform has received too little attention in the current fiscal debate. That is unfortunate, because the burdens of federal regulations are massive, now estimated at almost $2 trillion annually.
My proposal would save relatively little taxpayer money directly, but the larger impact of a more liberalized medical exploration process would be tremendous. It would enhance individual liberty and the range of medical options for countless Americans. It would also increase economic growth and harness the cost-reducing impact of technological innovation.
It is important to note that the costs imposed by FDA regulation are measured also in terms of human lives. FDA restrictions have significantly increased the costs of research and time of diffusion for the development of new, health-enhancing products. On average, it may take an innovator up to 15 years and as much as $1 billion to move a drug from the laboratory to FDA approval.
Health care innovations face much greater impediments than innovations in most other sectors of the economy. Elsewhere, entrepreneurs conceive new products that they believe offer value to consumers, introduce them to the market, and hope that consumers will buy them.
In health care, nothing can be introduced until it has received FDA approval. However, as a government agency that cannot be made immune to politics, the FDA is highly sensitive to any unintended mishap for which it might be blamed. For example, former FDA Commissioner Alexander M. Schmidt noted in 1974: “In all of FDA’s history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren't able to count them. . . . The message to FDA staff could not be clearer.”
The message is that the agency should always err on the side of over-caution.
There is no such thing as a perfectly safe drug or medical device, thus approvals sometimes create identifiable “victims.” On the other hand, the victims of FDA intransigence—those who never get a chance to benefit from the health-enhancing treatments that the agency has blocked or delayed—are unknown and politically invisible, and thus the agency is held blameless for them. Medical innovation is an inherently complex process, with just one of every 250 drugs which begins clinical testing ever making it to market.
Clearly, another strategy for medical innovation is needed. Milton Friedman argued that the quality of our health care would advance more rapidly if the FDA were abolished. My suggestion is a bit more modest. I would simply liberalize the FDA’s gatekeeper policies, allowing each of us—if we wish—to escape our “victim” status and to allow us one last chance, at the end of our lives, to dare the unknown, to perform one last heroic act.
At some point, a doctor will say, “Mr. Smith, there’s nothing more I can do for you.” Yet in many cases, although no approved intervention may exist, there will be a list of potential interventions that might address my “incurable” ailment. Must we check out as victims, or might we instead be given the opportunity to go out as heroes?
Naturally, some paths will lead literally to dead ends. Taking the wrong path entails both high costs and great dangers. Unlike Lazarus, we are all on a one-way trip through life, and sometimes fate or our bad choices shorten that trip. We would have to develop a reasonable informed consent protocol: Volunteers should be aware that their selected intervention is unlikely to succeed and that they might experience painful side-effects or an earlier death. They should give up the right to sue, and they may need to bear the costs of treatment themselves. Offsetting this, however, would be the individualist value of being in control of the final leg of one’s life journey. I’d like to have that opportunity, and millions of other Americans would, too.
Thus, my recommendation is to allow us all to elect to perform for our fellow citizens (and our descendants) one final heroic act. As free individuals, shouldn’t we be allowed to volunteer as Medical Magellans to explore those possible passages to a healthier world?