FDA Shock

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 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.

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 drug’s
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 FDA’s 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.