An Unusually Clear Example of the Cost of the FDA

The US Food and Drug Administration is a ball and chain holding back progress; its policies form a straitjacket of regulation that is heavy and stifling even by modern Western standards of governance, in which bureaucratic bodies intervene aggressively in near every aspect of life and economic activity. Interventions in clinical development, scientific research, and application of medical products impose staggering costs, and so what little can get through the onerous FDA process is made very expensive. But costs come in more forms than just the financial - there are the many beneficial forms of medicine that are simply not developed, or that exist but are not available in the US because FDA regulations make it impossible to offer them profitably. There is the research that is not funded because the end results cannot be brought to the clinic under present FDA rules.

That last point is particularly important for longevity science and the future of rejuvenation biotechnology. It is illegal in the US to bring therapies for aging to the clinic, because the FDA doesn't recognize aging as a legitimate use for medicine. Medical research moves fast these days, but it can still take five to ten years and millions of dollars in lining lobbyists' and politicians' pockets to get the FDA to recognize a new medical condition - which is only the start of spending hundreds of millions more to jump through the largely unnecessary hurdles of clinical trials as they are presently structured.

The FDA, like all bureaucratic organizations, long ago came to serve its own continuance above and beyond all other goals. Its own continuance as a political organization depends on releasing as few new medical advances as possible. Approval of medicine that never causes problems gains the bureaucrats no reward, while approval of medicine that does at some point cause problems results in punishment - there is no such thing as an absolutely safe medicine, of course, and the popular media will pillory the FDA for events that are well within the expected range of risk and reward in medicine. A low rate of approval of new technologies causes little harm to the bureaucrats, in comparison, and thus is acceptable for their needs, which is to say a job and a career. Thus the self-interest of those in charge of the FDA at all levels leads to an organization structured to actively sabotage its original goals; this is more or less the place in which all government organizations wind up.

In any case, here is an example of the cost of the FDA, with some numbers, and a line of research abandoned as being too expensive under the present regulations:

Biotechnology firm Geron said last night that it would discontinue its stem-cell research program and halt a pioneering clinical study in people with spinal-cord injury. The decision brings to a halt the world's largest and longest-running program to develop medical treatments from embryonic stem cells, versatile cells able to form many other types of human tissue.


The company denied it had given up on stem cells for scientific reasons. "We're not doing this because we were souring on the field, or as a result of any problems - we have not had any safety issues at all," Scarlett told Bloomberg news.


The attempt to study stem cells in humans had proved stupendously expensive and slow-moving for Geron. The company estimated that it spent $45 million just to win FDA approval for the initial safety trial of its treatment, known as GRNOPC1. As of October, however, only four patients had been treated, and the company would have had to spend tens of millions more in order to finish the study.

We can be fairly certain that, because embryonic stem cells were a political topic for some years, career-minded heads at the FDA found all sorts of ways to make it more costly for Geron to satisfy their requirements, and at greater cost. If a bureaucrat sees a raised likelihood of review, blame, and greater attention, then he will require far more effort from those he is regulating. More data, more cast iron assurances, more studies, and so forth. Though of course if you read much of the mainstream press on the topic, you'll see no commentary on the role of the FDA and the related costs in this end result. A cynic would not be surprised.