FDA Shock

In a stunning
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]

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

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. 


Well, snake oil is certainly safe...

backed by Chief Judge (and GMU faculty member) Douglas Ginsburg

Ah, if only he had made it to the Supreme Court. Something I will never forgive Nina Totenberg (or others) for.

I do not have time to read the entire decision right now, so maybe it addresses this point, but I cannot see the logic for requiring the drugs to have gone through even the initial safety trials. Patients who are terminally ill might well be willing to risk a drug whose safety hasn't been proven. What do they have to lose?

So long as the safty standard parts is improved and enforced.
This is after all a system in which an acne drug that can cause suicidal depression is considered safe for teens who are already high risk of depression.

Where was my girl, Janice Rogers Brown, on this case?

Are there any significant medical researchers who would support this? As a student, I find it really hard to swallow that this is a good idea. I would really be interested in seeing how people are quantifying the fact that cost is holding back drug development instead of knowledge (basic science of signaling pathways). I mean, my understanding is, that its really a significant lack of knowledge, and most low-hanging fruit has already been culled.

"Are there any significant medical researchers who would support this?"

Perhaps those who watched a loved one die who was denied access to drugs by the FDA, for starters.

As a pharma-guy myself, I have doubts about how this might work out. Judge Griffith's dissenting opinion raises some good practical points, I think. More discussion here, with comments from others in and around the industry.

Perhaps the FDA approval should not just be yes or no, but in degrees such as Bronze, Silver, and Gold.

Good idea. That's exactly what we (the Abigail Alliance) proposed to the FDA in 2003. They didn't respond within the required 180 days, so we were allowed to bring the suit.
Instead of Bronze, Silver, and Gold, it's Tier 1, Tier 2, and Tier 3. There's also a bill penidng in the Senate (S.1956) that would force this on the FDA.

Miller, Henry, 2000. To America's Health: A Proposal to Reform the Food and Drug Administration. Stanford, Calif.: Hoover Institution Press.

Miller is a former FDA Regulator who supports more of a market based approach to drug regulation.

I don't believe the FDA ever passed the constitutionality test. Nowhere in Article I, Section 8 is the congress authorized to have the government do the testing of food or drugs. Especially seeing as how the FDA Board is dominated by ex-pharma board members ("regulatory capture," you know), I'd like the whole thing scrapped and taken over by Underwriters' Labs.

Chairman, if people are dumb enough that they couldn't understand a separate numerical FDA efficacy rating and what needing medication means....I would still rather allow insurance companies to sue doctors who overprescribe.

Is that how it works now? Initiate a government sheme or policy to get a toe-hold in our understanding and keep the pressure on until it becomes firmly ingrained?

I've managed to save up roughly $75362 in my bank account, but I'm not sure if I should buy a house or not. Do you think the market is stable or do you think that home prices will decrease by a lot?

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