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Abigal Alliance v. FDA

In May I wrote about the stunning ruling by the DC Circuit Court of Appeals that dying patients have a due process right to access drugs once they have been through FDA approved safety trials.  (See the link for some amazing quotes from the ruling.)  The case is now on appeal and possibly headed to the Supreme Court and I am thrilled to have a role.

I am one of the authors of an Amici Curiae brief, a friend of the court brief.  The DC Circuit Court of Appeals made it's ruling based on the right to control one's own body:

A right of control over one’s body has deep roots in the common law. The venerable commentator on the common law William Blackstone wrote that the right to “personal security” includes “a person’s legal and uninterrupted enjoyment of his life, his limbs, his body, [and] his health,”...barring a terminally ill patient from use of a potentially life-saving treatment impinges on this right of self-preservation.

But the court noted that a patient's fundamental right could be rebutted if the FDA can show that its policy of barring access to these drugs is "narrowly tailored to serve a compelling governmental interest."

The brief, submitted by Jack Calfee, Dan Klein, Sam Peltzman, Benjamin Zycher and myself, argues that barring access to experimental drugs does not serve a compelling governmental interest and in fact reduces patient welfare.

Unfortunately, I do not think that the Abigail Alliance can win the case; recognizing the rights that the DC Circuit of Appeals recognized would be too big a blow to our nanny state.  Nevertheless, if we can help the court to be aware of some of the tradeoffs involved with drug regulation that will be valuable and it's also great to be on a paper with Peltzman.

Thanks also to Ted Frank and others for acting as Counsel for the Amici Economists.

Posted by Alex Tabarrok on January 23, 2007 at 07:39 AM in Economics, Law, Medicine | Permalink

Comments

But the court noted that a patient's fundamental right could be rebutted if the FDA can show that its policy of barring access to these drugs is "narrowly tailored to serve a compelling governmental interest."

That's the court's "strict scrutiny" test. A fundamental natural or constitutional right can still be violated by the US if the violation is "narrowly tailored to serve a compelling government interest." The state loses about 70% of the time under strict scrutiny.

Hopefully, the usage of drugs and the sanctity of one's own body eventually create a Roe v. Wade for drug laws, ending this tyrannical and stupid policy.

- Josh

Posted by: Wild Pegasus at Jan 23, 2007 8:34:00 AM

I agree. The FDA is a bureaucratic behemoth that needs to be chopped back. The cost of bringing a new drug through the entire regulatory process often exceeds $100 million. If Congress really wanted to do something about drug prices, it would reduce the amount of money that gets poured down this regulatory rathole. Whom do you think ends up paying for all this? That said, it will be interesting to see if the Supreme Court decides to review this case. The proper remedy here may be legislative, not judicial.

Posted by: Ned at Jan 23, 2007 9:56:22 AM

Yet, one of the few things most sides of the health care debate can agree on is that no matter who pays, we would be better off having a better idea of what treatments work how well.

Destroying even (arbitrary, bureaucratic) standard methods of measuring the safety and effectiveness of a treatment seems a step backwards in this regard.

Posted by: Cyrus at Jan 23, 2007 11:51:58 AM

If you want to reduce the nanny state in the drug market get rid of the government enforced monopolies created by the patent system.

This appears to me to be nibbling at the edges. Another point is that, apriori, I would have been for drugs for terminal patients. However, from what little I have learned, and it is very little to be sure, the question is more complicated than it initially sounded.

Posted by: theCoach at Jan 23, 2007 2:11:37 PM

Cyrus,
There are plenty of market incentives for providing that information.

Posted by: LisaMarie at Jan 23, 2007 4:46:15 PM

Prof. AT,

As smart as they may be, most of the legal establishment is apparently incapable of comprehending the idea that too much regulation can create more problems than remedies. Maybe it’s because their favorite clients are precisely the ones benefiting from a controlled market (i.e. drug manufacturers, criminal attorneys etc…).

They guise their elitist social club’s true intentions with bogus advocacy of social welfare and redistributive wealth policies. All this means is that they have society on a leash.

Posted by: Chairman Mao at Jan 23, 2007 4:53:31 PM

Lisa,

But also market incentives for obscuring it.

Posted by: Cyrus at Jan 24, 2007 7:16:50 AM

Hi
Best wishes
Allow me to offer my heartiest wishes.
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