Some F.D.A. Links

by Don Boudreaux on August 1, 2011

in FDA, History, Man of System, Nanny State, Regulation, Risk and Safety

Here are six links to scholarly work (including videos starring my GMU Econ colleague Alex Tabarrok) supporting the presumption that markets will more reliably protect people against harm on the pharmaceutical front – harm both from pharmaceuticals that people actually consume and harm from the failure or inability to consume pharmaceuticals:

A cornucopia of resources, assembled by my colleagues Dan Klein and Alex Tabarrok, of materials on the F.D.A.

The first of a series of videos of Alex discussing the F.D.A.

An EconTalk podcast with Sam Peltzman (and see the links that Russ includes at the EconTalk site).

Robert Higgs’s 1995 paper on the F.D.A.’s lethal regulation of medical devices.

Charles Hooper and David Henderson on the F.D.A.’s war on drugs.

Also, my GMU colleague Jack High – now in GMU’s School of Public Policy – wrote several papers about 20 years ago on the not-so-reassuring origins of the Pure Food Act.  See, for example, Jack’s paper with Clayton Coppin entitled “Wiley and the Whiskey Industry: Strategic Behavior in the Passage of the Pure Food Act,” Business History Review (Summer 1988), Vol. 62, pp. 286-309.

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Steve Cronk August 1, 2011 at 1:02 pm

I often show people this link when discussing the FDA

Don Boudreaux August 1, 2011 at 1:04 pm

Yep. That’s one that I list in my post.

Peter P. August 1, 2011 at 1:19 pm

I would include Epstein on property rights and drug patents…

His op-ed two years ago on cancer patients and “off-label” use in the WSJ…

Steve Cronk August 1, 2011 at 1:31 pm

Ah. I don’t know how I skipped right over it. Excellent, then.

Daniel Kuehn August 1, 2011 at 1:40 pm

- Klein and Tabbarok mention Peltzman’s 1973 paper – I’d be very interested in knowing if anyone know where the data is for this or if its publicly available.

- On the FDA it’s important to distinguish between (1.) efficacy studies, (2.) safety studies, and (3.) restrictions on marketing. I think the arguments for (2.) are decent and it just needs to be determined if there’s really a public role for this (I find both sides plausible – I just don’t know which is right) and very bad arguments for (1.) and (3.). Oftentimes people just presume you’re supporting a draconian FDA when you raise arguments in support of the idea of it.

Don Boudreaux August 1, 2011 at 2:10 pm

What objective standards are available to determine whether or not a drug is safe? You write, Daniel, as if “safe” is an objective fact – either a drug is or isn’t safe (or is or isn’t sufficiently safe). But what’s safe for me might not be safe for you – that is, I might have a higher tolerance for risk than you, in which case the same physical properties of the drug are safe for me but unsafe for you. (I ignore here possible physical differences in our bodies and how these might affect the drug’s effect in you as compared to in me.)

If you understand that preferences are subjective, you understand that there is absolutely no scientific way to test to see if a drug is “safe” or “unsafe” for any number of people larger than one. Science can describe various risks associated with a drug, but doing so is not – and cannot possibly be – to determine if a drug is “safe” or not for the public. ‘The public’ has no risk preferences that are relevant to the individuals who comprise ‘the public.’ The fact that a majority of my neighbors would prefer not to take drug X to cure their leukemia or skin rashes or dysfunctioning erections does not mean that I share that preference or that I SHOULD, by any objective standard, share that preference.

You might say “Well, let’s just have the F.D.A. objectively test the properties of drugs on typical human beings and make that information available; people can then choose, based upon this information, whether or not to take a drug.” I’d agree that that’d be a much better arrangement than we have now, for now we have an allegedly science-based organization pursuing an enterprise that economists have known for at least 140 years to be the equivalent of witch-doctory (namely, determining whether or not various drugs are sufficiently safe for a collective of countless people).

[No amount of skill at medical science can make up here for the F.D.A.'s absolute ignorance of, and disregard of, economic science. (I'm talking here about a part of sound economic science - namely, the recognition that individuals' tastes and preferences vary across persons and are subjective - and not that part of economic 'science' built on the mistaken notion that markets work well only when there are no information asymmetries and other so-called 'market imperfections.')]

I see no reason why government would be required to supply such information if there is sufficient consumer demand for it.

Daniel Kuehn August 1, 2011 at 2:44 pm

Subjective preferences are going to determine what risk level you are willing to tolerate. Presumably the risks themselves can be nailed down to some reasonable degree.

re: ” I’d agree that that’d be a much better arrangement than we have now”

Good – I’d say that too.

Don Boudreaux August 1, 2011 at 3:07 pm

But why must government supply such testing and information on risks? People have ways of getting such information for automobiles, electric toasters, and mountain-climbing equipment. Why would such private sources be unavailable or unreliable for something as important as pharmaceuticals?

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