In a stunning decision the DC Circuit Court of Appeals ruled
yesterday that dying patients have a due process right to
access drugs once they have been through FDA approved safety
trials. The FDA's refusal to allow firms to sell and
patients to buy these drugs "impinges upon an individual
liberty deeply rooted in our Nation's history and tradition
of [respecting the right of] self-preservation."
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." (This issue will be decided on remand). But the
opinion, by Clinton appointee Judge Judith Rogers and backed
by Chief Judge (and GMU faculty member) Douglas Ginsburg, is
strongly worded.
The court writes:
A right of control over ones 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 persons 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.
In perhaps the most shocking statement the court says the
FDA is like someone who interferes with another person
trying to aid a third. The court cites the Restatement
(First) of Torts:
[someone who] intentionally prevents a third person from
giving to another aid necessary to his bodily security, is
liable for bodily harm caused to the other by the absence of
aid which he has prevented the third person from giving.
The Court also notes:
Government regulation of drugs premised on concern over a
new drugs efficacy, as opposed to its safety, is of recent
origin. And even today, a patient may use a drug for
unapproved purposes even where the drug may be unsafe or
ineffective for the off-label purpose. Despite the FDAs
claims to the contrary, therefore, it cannot be said that
government control of access to potentially life-saving
medication is now firmly ingrained in our understanding of
the appropriate role of government,...
If the court's ruling is upheld it will begin a return to
the pre-1962 system in which safety trials alone were
required for marketing approval. I have long advocated
returning to a safety-only system. FDA regulation creates
drug lag and drug loss - delays in the introduction of new
drugs and increases in the costs of R&D resulting in fewer
new drugs. While more extensive testing is not without
benefits, FDA incentives practically ensure that caution
will be excessive.
The court was also right to point to the vitality and
importance of off-label prescribing. Once a drug has been
approved for some use it can be prescribed for any use, even
one quite different than the one for which it was approved.
Since new uses for old drugs are discovered all the time
what this means is that we already have a voluntary system
of drug review and approval that exists outside and apart
from the apparatus of the FDA. A safety-only system does
not mean an absence of regulation it means greater reliance
on a voluntary regulatory system that better takes into
account the hetereogeneity of patient diseases and
preferences - what I have called the Consumer Reports model
of regulation rather than our current paternalistic model.
The case, by the way, was brought by the Abigail Alliance
named after Abigail Burroughs who died after repeated
requests to access experimental drugs were denied, it was
later shown that the drugs were effective and could have
prolonged her life.
-- from http://snipurl.com/q1ol
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