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.


So, if we hope to "beat the ageing process" within 20-30 per DeGray and Kurzeill, it would be necessary to get rid of or change the FDA or this will not happen.
Makes sense, right?

Posted by: Robert Church at November 15th, 2011 6:32 PM

I don't think we'll "get rid" of the FDA. Changes will need to be made, or there will need to a much sooner and larger exodus of biotech research to the East in order to hit the 20-30 number, probably, from what I have read.

Posted by: Matt at November 16th, 2011 8:11 AM

Why can't the research and product development be done in Hong Kong or Australia? Once the treatment is developed, people will travel long distances in order to live longer. Besides China has all the investment money and its run by wrinkled old men.

Posted by: sol at November 16th, 2011 3:38 PM

Of course the Constitution gives the Federal Government (tm) no powers in medicine.

The FDA should be abolished, absent an amendment to give the Federal Government (tm) such authority.

Posted by: DonM at November 16th, 2011 4:25 PM

My friend once worked for a company that had developed an artificial cerebrospinal fluid. This fluid could be oxygenated, and metered into the cerebral cavity to replace the existing fluid; this would be used to provide oxygen to blocked areas of the brain during a stroke. The company got to clinical trials, but the trials went so slowly they ran out of money and went out of business. They did not budget for anything other than a lick-and-a-promise approval, just about "don't kill one patient and you're good", because they didn't think that the FDA would cause any trouble for something that demonstrably stopped brain damage due to stroke.

Posted by: DensityDuck at November 16th, 2011 4:42 PM


Posted by: WILLIAM RISLEY at November 16th, 2011 4:51 PM

Gets it right: The FDA is institutionally risk averse. You only get hauled in front of the cameras by congress if you release a thalidomide.

Gets it wrong: Embryonic stem cell research is likely to get the benefit of agency bureaucrats - it is important to the pro-choice crowd that the "science" be funded by the taxpayer.

Occam's razor: Embryonic stem cells did not pan out in this situation and Geron cut their losses.

Posted by: Chip at November 16th, 2011 5:26 PM

The next decade will see significant medical research moved to Asia; the process has already started. Thirty years ago you had to do the work here because no place else had the expertise or market. By 2025 most new medical treatments will be developed outside the US and only later, if at all, imported. It will be commonplace for upperclass people to travel to Asia and South America for treatments.

Posted by: Over50 at November 16th, 2011 5:44 PM

Step 1 allow in all japanease, European and other first world approved drugs.

Step 2 allow people to opt out of the FDA approval with a one page warning contract.

Step 3 figure out which new medicines you want to try

Posted by: Steve adams at November 16th, 2011 6:04 PM

We too have walked away from the FDA process - we will simply make it available to the public, publish the studies independently, make no claims (because the FDA controls speech) and let the consumer educate himself - this is the future of medicine - this column is the tiniest tip of an iceberg that is freezing all research - problems at Big Pharma, impossible obstacles for small pharma by the FDA - this is a zero sum game and quite soon, you will be learning Spanish to get your meds. Via con Dios.

Posted by: Judge Arrow at November 16th, 2011 6:53 PM

Looking for FDA costs? Yeah, thats hard to find.
Every hear of Colchicine?
Its a Gout medication. About the only one that stops it when it occurs. It has been around since before this country was discovered.
Mention of it has been found in Egyptian papyrus dating back to 1500BC.
It comes from a certain flower.
Benjamin Franklin brought some of the plants over here from Europe.

Since its been around so long, and since everybody makes it, its super cheap.
I think about 10-20 cents per pill, if that much.

At least that is what it used to cost.

But, due to our wonderful Federal Government, it is now called Colcrys, and they get $6.00 per pill!!

It seems the FDA did not have anything to do one day, so they asked a drug company to do research on some of the orphan drugs that predated the FDA.
So the the drug companies could get their cost back, they gave the company exclusive rights to make and sell the stuff.

The company promptly sued everybody else making it to make sure they stopped, and raised the price to about $4.00. Now it has crept up to $6.00+ per pill.

Plus, the FDA has posted rules to the effect that anyone caught making or selling the generic is subject to arrest.

I now have to bootleg the stuff out of Canada for 30 cents per pill, which is its self exorbitant.

But, better than $6.00 per pill..........

Posted by: J. Varnum at November 16th, 2011 7:06 PM
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