Abolish the FDA

[Chmee]

Don Boudreaux has a good series of posts on why we should abolish the FDA.

http://cafehayek.typepad.com/hayek/2004 ... ing_a.html

I'm Not Joking: Abolish the FDA

While guest-blogging at the Club for Growth, I suggested that the Food and Drug Administration (FDA) cannot possibly serve a valid public service. The reasons are many, but one of the most fundamental is that the standards that the FDA is charged with enforcing are inherently indefinable.

The words "safe" and "effective" sound straightforward and simple, but they’re meaningless as guideposts for person A to use when forcibly substituting his judgment for that of person B in determining if some drug is sufficiently "safe and effective" for person B to use. This problem expands exponentially when there are 300 million person Bs.

The only possible escape from this problem is to define "safe" as meaning absolute and total absence of risk for every potential user of a drug, and by "effective" as meaning 100% assurance of positive results for every potential user – an impossible standard.

Several folks have written me, expressing their skepticism.

One reader thought I was joking. Another reader – a friend who is a prominent market-oriented scholar – wrote that I see the world too starkly, in black-and-white, while in fact, this friend says, the world has many shades of gray.

Here’s my response to this friend.

It’s precisely because I understand that the world is emphatically not black and white that I oppose FDA regulation.

I prefer to let each individual choose his or her preferred level of drug safety. Most folks, of course, will consult physicians, and I have no doubt that private certification services will arise on the market to supply further information about drug risks and effectiveness. In my preferred world, each person chooses his or her own level of drug safety.

There would be no make-believe "objective" dividing line ostensibly distinguishing "safe" from "unsafe" drugs -- and no centralized, politicized decision arbitrarily prohibiting the use of all drugs that fall on the wrong side of that necessarily arbitrarily drawn line. Moreover, because we each differ from each other -- in our likely reaction to drugs, in the extent of our illnesses requiring treatment with drugs, and in our tolerance for risk -- in my world each of us would be better able to satisfy more fully each of our respective demands for drugs.

As I see matters, the true black-and-white world view is the one that perceives an objective and easily definable minimum level of drug safety suitable for every American – an objective and easily definable level that we can trust distant bureaucrats to discover and enforce.

See this superb article by Bob Higgs for a deeper analysis.

I think he is right. Safe means different things to different people in different situations and trying to come up with one common standard for everyone is undoubtably going to serve some people poorly. Putting that common standard law leaves those people for who it is a poor choice few options (other than leave the country). Looking into the safety of food and drugs is a valuable service, but it is one that will get performed without the governments providing it.

More posts from Boudreaux on the subject.

http://cafehayek.typepad.com/hayek/2004 ... so_li.html

http://cafehayek.typepad.com/hayek/2004 ... e_fda.html

http://cafehayek.typepad.com/hayek/2004 ... _to_a.html

[Aslanna]

I prefer to let each individual choose his or her preferred level of drug safety.

Well there's a stellar idea.

[Zaelath]

This guy clearly doesn't even know what the FDA does.

[Neroon]

I'm going to have to agree with Zaelath here. The FDA deals with a lot more than prescription drugs. Food saftey, medical device safety, radiation, etc.

And to say that they decide whether drug X is safe or not is misleading as well. They decide if it's going to kill people, then say "no Mr. money-hungry pharmaceutical company, you cannot sell that". If not, and it has side effects, they force them to label them as such. I would call those pretty valuable services. Especially given the average drug maker would just as soon kill you as heal you if it would make them a buck.

[Aaeamdar]

Moslty it is the job of the FDA to turn 17 year patents into 5 years of worth, thus driving the costs of healthcare up. I agree completely with Chmee (and the opinions of those he quotes), the FDA serves no purpose that would not better be served by other private institutions. Further, people don't generally treat themselves, they see a doctor who provides adive on what medications, if an, to take. A doctor's advice is certainly limited by the FDA, but I don't think you can argue that doctors could not make informaed decisions and provide good advice with out it.

Sadly, it is a libertarian fantasy that such thing would ever happen, but if it did happen it would be a good thing. No one's health is being protected by the FDA, its an illusion of help much in the vein of Homeland Security (no attacks, so it must be working).

If not, and it has side effects, they force them to label them as such. I would call those pretty valuable services.

Not really. See as an attorney that has work for major drug comapnys I am somewhat informed as to the process. It is quite similar to the *risks* sections in a prospectus - every risk under the sun is listed as potentially catastrophic, thus any real risk is hidden in the noise. Its the same with drugs and their FDA lables. Every sympton described by the test group during the human subject phase is listed as a sideeffect, thus any real risk (if such a thing could be determined reasonablely) is hidden in the laundry list of symptoms experienced by the test subjects and presumed to be causal.

[Midnyte_Ragebringer]

This guy clearly doesn't even know what the FDA does.

/nod


It's typical though. Abolish the FDA!!!! Instead of lets improve the FDA. /sigh

[Aaeamdar]

So where has the FDA gone wrong in your eyes and what elements should be improved? By arguing "improve" over "abolish" I presume you know of some inefficiencies that once corrected could have the FDA running well.

See the original poster, Chmee and I all see the flaws as being in the concept itself, not in its execution. Since you approve of teh concept, but see room for imporivement, why not tell us about those areas. Maybe we are wrong and your explanation could help show us.

[Chmee]

I prefer to let each individual choose his or her preferred level of drug safety.

Well there's a stellar idea.

Actually, it is. As Aaeamdar points out patients are not likely to be doing this in a void, they will still rely on doctor's advice and other sources. But not all people are the same. For some people a somewhat risky drug might be an unwarranted risk to take, for others it might be their only chance at life. The FDA mostly treats everyone the same and generally is more likely to err on the side of caution, even if that means that people may die when a drug could have potentially saved them (since those stories rarely make the front line news like a case where a drug does have a harmful effect on people).

[Chmee]

This guy clearly doesn't even know what the FDA does.

Donald J. Boudreaux is Chairman of the Department of Economics at George Mason University in Fairfax, Virginia. He's held this position since August 2001. Previously, he was president of the Foundation for Economic Education (1997-2001); Associate Professor of Legal Studies and Economics at Clemson University (1992-1997); and Assistant Professor of Economics at George Mason University (1985-1989).
During the Spring 1996 semester he was an Olin Visiting Fellow in Law and Economics at the Cornell Law School. His PhD in economics is from Auburn University (1986) and his law degree is from the University of Virginia (1992).

He has lectured, in the United States, Canada, Latin America, and Europe, on a wide variety of topics, including the nature of law, antitrust law and economics, and international trade. He is published in The Wall Street Journal, Investor's Business Daily, Regulation, Reason, Ideas on Liberty, The Washington Times, The Journal of Commerce, the Cato Journal, and several scholarly journals such as the Supreme Court Economic Review, Southern Economic Journal, Antitrust Bulletin, and Journal of Money, Credit, and Banking.

I suspect that Professor Boudreaux has at least a reasonable idea of what the FDA does. Not that his credentials means that he is automatically correct, but then you didn't really address his argument.

[Midnyte_Ragebringer]

So where has the FDA gone wrong in your eyes and what elements should be improved? By arguing "improve" over "abolish" I presume you know of some inefficiencies that once corrected could have the FDA running well.

See the original poster, Chmee and I all see the flaws as being in the concept itself, not in its execution. Since you approve of teh concept, but see room for imporivement, why not tell us about those areas. Maybe we are wrong and your explanation could help show us.

The concept is wrong? ROFL

The concept of a government agency protecting its people by overseeing the safety of FOOD, DRUGS, MEDICAL DEVICES, ANIMAL FEED and DRUGS, COSMETICS, and RADIATION-EMITTING PRODUCTS sounds bad?

And by the way, I see improvement everything. Nothing is perfect. Every single solitary thing has room for improvement.

[Pherr the Dorf]

So where has the FDA gone wrong in your eyes and what elements should be improved? By arguing "improve" over "abolish" I presume you know of some inefficiencies that once corrected could have the FDA running well.

See the original poster, Chmee and I all see the flaws as being in the concept itself, not in its execution. Since you approve of teh concept, but see room for imporivement, why not tell us about those areas. Maybe we are wrong and your explanation could help show us.

The concept is wrong? ROFL

The concept of a government agency protecting its people by overseeing the safety of FOOD, DRUGS, MEDICAL DEVICES, ANIMAL FEED and DRUGS, COSMETICS, and RADIATION-EMITTING PRODUCTS sounds bad?

And by the way, I see improvement everything. Nothing is perfect. Every single solitary thing has room for improvement.

Not the first time this has ever happened but Mid is dead on right

[Denadeb]

Like the FDA approveing the use of investigational drugs in Military people. IMO they have a long way to go to fix the problems they have.

[Zaelath]

I prefer to let each individual choose his or her preferred level of drug safety.

Well there's a stellar idea.

Actually, it is. As Aaeamdar points out patients are not likely to be doing this in a void, they will still rely on doctor's advice and other sources. But not all people are the same. For some people a somewhat risky drug might be an unwarranted risk to take, for others it might be their only chance at life. The FDA mostly treats everyone the same and generally is more likely to err on the side of caution, even if that means that people may die when a drug could have potentially saved them (since those stories rarely make the front line news like a case where a drug does have a harmful effect on people).

And where is the doctor going to get his information on the safety/side-effects,. combinational hazards, etc of a drug that's new to the market? Sorry, but GPs don't have the time nor the expertise to replace the FDA.

I'm not saying it's perfect, or even tolerably competent, but it's not unnecessary either.

[Chmee]

The concept of a government agency protecting its people by overseeing the safety of FOOD, DRUGS, MEDICAL DEVICES, ANIMAL FEED and DRUGS, COSMETICS, and RADIATION-EMITTING PRODUCTS sounds bad?

Yep, when the structure of the agency is such that it is likely to cause more problems than it solves. For the reasons given on the thread and in the referenced links. None of which you have really addressed other than just trying to say "its crazy!".

[Aaeamdar]

So where has the FDA gone wrong in your eyes and what elements should be improved? By arguing "improve" over "abolish" I presume you know of some inefficiencies that once corrected could have the FDA running well.

See the original poster, Chmee and I all see the flaws as being in the concept itself, not in its execution. Since you approve of teh concept, but see room for imporivement, why not tell us about those areas. Maybe we are wrong and your explanation could help show us.

The concept is wrong? ROFL

The concept of a government agency protecting its people by overseeing the safety of FOOD, DRUGS, MEDICAL DEVICES, ANIMAL FEED and DRUGS, COSMETICS, and RADIATION-EMITTING PRODUCTS sounds bad?

And by the way, I see improvement everything. Nothing is perfect. Every single solitary thing has room for improvement.

So, in other words, you have nothing specific to say. You have concluded from the agency's stated goals (or more precisely, what you infer from its name) that being against it must be "crazy" and you cop out on "improvement" by suggesting everything should be improved - nothing specifically is wrong, but you are confident that it should be improved, so you suggest improvement. As is usual, in other words, you know nothing but thought it best to share your opinion on it anyway.

[Midnyte_Ragebringer]

So where has the FDA gone wrong in your eyes and what elements should be improved? By arguing "improve" over "abolish" I presume you know of some inefficiencies that once corrected could have the FDA running well.

See the original poster, Chmee and I all see the flaws as being in the concept itself, not in its execution. Since you approve of teh concept, but see room for imporivement, why not tell us about those areas. Maybe we are wrong and your explanation could help show us.

The concept is wrong? ROFL

The concept of a government agency protecting its people by overseeing the safety of FOOD, DRUGS, MEDICAL DEVICES, ANIMAL FEED and DRUGS, COSMETICS, and RADIATION-EMITTING PRODUCTS sounds bad?

And by the way, I see improvement everything. Nothing is perfect. Every single solitary thing has room for improvement.

So, in other words, you have nothing specific to say. You have concluded from the agency's stated goals (or more precisely, what you infer from its name) that being against it must be "crazy" and you cop out on "improvement" by suggesting everything should be improved - nothing specifically is wrong, but you are confident that it should be improved, so you suggest improvement. As is usual, in other words, you know nothing but thought it best to share your opinion on it anyway.

LOL

[Aaeamdar]

And where is the doctor going to get his information on the safety/side-effects,. combinational hazards, etc of a drug that's new to the market? Sorry, but GPs don't have the time nor the expertise to replace the FDA.

This assumes that FDA adequately provides this information in the current state. It does not. The place you can moist readily get reasonable information on these effects is from the publications of the drugs in hiuman studies. These studies start before FDA requirements and continue after the FDA approves the drugs. As examples, the recent case of cyclooxygenase in Vioxx and Celebrex. Note how the two companies conducted similar post-FDA test, how both came to similar results, but how the companies differed on their approach to those results.