No Constitutional Right to Drugs:
The U.S. Court of Appeals for the D.C. Circuit has just released its long-awaited en banc decision in Abigail Alliance v. Eschenbach. As anticipated, the Court held 8-2, against the Abigail Alliance for Better Access to Developmental Drugs. The majority opinion, written by Judge Griffith, begins:
This case presents the question whether the Constitution provides terminally ill patients a right of access to experimental drugs that have passed limited safety trials but have not been proven safe and effective. The district court held there is no such right. A divided panel of this Court held there is. Because we conclude that there is no fundamental right “deeply rooted in this Nation’s history and tradition” of access to experimental drugs for the terminally ill . . . we affirm the judgment of the district court.Judge Rogers, joined by Chief Judge Ginsburg, dissented.
For some earlier posts on this case see here. More to follow.
UPDATE: For more past blogging on the case, see Randy Barnett's posts here and this post from Glenn Cohen (who worked on the case) from Prawfsblawg.
Related Posts (on one page):
- Abigail Alliance and therapeutic cloning
- Abigail Alliance -- The Practitioners Respond:
- Roger Pilon on Abigail Alliance:
- A Practitioner's Perspective on Abigail Alliance:
- More on Abigail Alliance:
- Judge Rogers' Abigail Alliance Dissent:
- Jessie Hill on Abigail Alliance:
- Some Thoughts on Abigail Alliance:
- No Constitutional Right to Drugs:
Did Ginsburg think they meant marijuana?
[Runs away.]
Steve, given the courts' reluctance to make up new freedoms in the Constitution, that characterization isn't very fair.
What new freedoms? In 1789 Americans had the right to ingest anything they could find or produce (unless they were Indians).
Amendment IX
The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.
Amendment X
The powers not delegated to the United States by the Constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people.
While I have a lot of respect for the writers of the constitution, I do not believe it is reasonable for them to provide that 220 years later there be an explicit right for drugs that have not been proven safe and effective. The above two amendments appear to cover the situation. It must be nice to just ignore the parts one doesn't like.
They claim that their decision doesn't implicate the constitutional right to life, even though the FDA bans drugs that doctors view as the best hope for their patients, because "the collective judgment of the scientific and medical community is expressed through the FDA's clinical testing process."
Survey after survey has shown that doctors think the FDA is too slow in approving drugs. They emphatically DO NOT view the FDA's ponderous processes as reflecting the "collective judgment of the scientific and medical community," and it is not (the FDA has every institutional incentive to delay approval of needed drugs, since no FDA bureaucrat has ever been fired for delaying approval of life-saving drugs, but they attract congressional scrutiny in the much rarer cases in which they approve drugs too soon).
The plaintiffs submitted affidavits from doctors identifying specific drugs that might save patients' lives, and which have passed the first (safety-oriented) phase of FDA review, but which the FDA bans use of, pending the drug undergoing additional efficacy-related testing that requires an incredibly lengthy and slow approval process.
The majority simply ignored those affidavits, even though the case was decided on a motion to dismiss, where Rule 12(b)(6) required the majority to accept the truth of those affidavits.
It just ignored basic court rules in making its unsupported assertions.
I haven't read the opinion, but that's an obvious misstatement of the law. A Rule 12(b)(6) motion does not permit the court to consider material outside the complaint submitted by either party. If the complaint itself alleges the same facts contained in the affidavits, then the court would have to assume the truth of those allegations, but the court cannot rely on or consider any material outside the complaint, including affidavits submitted by the non-moving party, in deciding whether the complaint states a valid claim for purposes of 12(b)(6).
The court asserted that the FDA's restrictions on experimental drugs can't infringe the Fifth Amendment's right to live because they don't involve drugs considered by the scientific community to be safe.
For this assertion, it argued that "the collective judgment of the scientific and medical community is expressed through the FDA's clinical testing process."
But it cited no facts to support this, and indeed, the only evidence submitted in the case suggests that many in the scientific community do view drugs as being the safest and most effective treatment available even when it is has not completed the FDA clinical testing process.
For examples of many surveys in which doctors have faulted FDA for being too slow in approving drugs and thereby harming their patients, see the article by former FDA official Henry Miller, "Failed FDA Reform," Regulation magazine, Volume 21, No. 3 (1998), which begins on page 24.
(www.cato.org/pubs/regulation/regv21n3/v21n3-ftr2.pdf)
Miller cited an August 1995 survey of oncologists, which found that nearly two-thirds of respondents believed the FDA has "hurt their ability to give the best possible care to a patient on at least one occasion," and over one in ten believed this has happened "frequently." (Pg. 25).
Miller also cited a July 1996 survey of oncologists in which "half maintained that FDA regulations prevent them from using promising new drugs or medical devices, 71 percent felt that FDA's approval process had hurt their ability to give patients the best care, and 57 percent said that unnecessary delays in product approval by FDA actually cost lives." (Pg. 25).
Miller also noted that the FDA frequently delays in approving drugs even when the drugs have long since been approved abroad and have been found by regulatory and health agencies in many countries to be safe and effective. (Pg. 24).
It was only the August 1995 survey that involved oncologists.
You're running smack into the Commerce Clause, my friends.
If congress can old hearings on idiocy like Alar and steroids in baseball, you'd think they could take the time to pass a law where the harm that can be done to an individual is negligible.
I tire of everything being an issue for the courts because democracy is just too darn inconvenient. Easier to convince 9 people than hundreds or even millions I guess.
Of course they could. Agreed w/ Fraggle that it becomes tedious to see lobbying taken to the courts, tho I would blame the decay of our legislative institutions, not just plaintiffs.
Au Contraire, in no way does the Commerce Clause empower the government to regulate things traded in interstate commerce, merely the commerce itself. Of course, the government has long since arrogated that power to itself but that's raw power, not the Constitution.
The fact that Congress can regulate under the Commerce Clause doesn't mean that the regulated activity ceases to be constitutionally protected.
The federal law banning partial-birth abortion was passed under the Commerce Clause, but no justice suggested that it thereby was exempt from challenge based on its alleged infringement on women's privacy rights.
The Communications Decency Act has been held to be an exercise of Congress's commerce powers, enabling it to validly preempt certain state laws, but that didn't stop the Supreme Court from holding that it was fully subject to First Amendment scrutiny in Reno v. ACLU, which led to part of the Act -- its ban on indecency -- being struck down as a violation of free speech.
Federal law regulated gambling ads under the Commerce Clause, but that didn't stop some such regulations from being struck down on First Amendment grounds by the Ninth Circuit and the Supreme Court.
As comments above have noted, surveys of doctors have repeatedly shown that the "collective judgment" of the medical community is NOT expressed through the FDA's clinical testing process.
More importantly, the FDA is inherently unable to express the collective judgments of the scientific and medical communities.
The FDA is accountable to politicians, not the medical or scientific communities, and it thus has every institutional incentive to delay approval of needed drugs, rather than implementing the judgment of the scientific or medical communities favoring such drugs.
No FDA bureaucrat has ever been fired for delaying approval of life-saving drugs. By contrast, FDA officials know they are sure to be chastised by publicity-seeking congressmen in the rare case in which the FDA approves a drug too soon that turns out to have unanticipated safety risks.
As the dissent pointed out, it is deeply ironic that the federal courts have recognized a host of rights not mentioned in the text of the Constitution, such as the rights "to perform varied sexual acts in private and to control one's own body even if it results in one's own death or the death of a fetus," even while "the right to save one's life is left out in the cold despite its textual anchor in the right to life."
The court majority attempted to distinguish away those other rights recognized by the courts, like the right to refuse unwanted medical treatment even when that results in one's death, by claiming that a ban on experimental drugs involves "affirmative access" to a "commercial good" rather than the "freedom" from "forced medical treatment."
That is an absurd distinction. If the judges in the court majority were denied the right to buy food, and thus condemned to starvation, no one would argue that their right to live was not infringed merely because buying food involves "affirmative access" to a "commercial good."
Most constitutional rights necessarily involve "access" to a "commercial good." A newspaper can't exercise its First Amendment right to publish unless it is allowed to buy "commercial goods" like newsprint and paper. A political candidate can't communicate with voters without spending money on ads. And it is well-established that the First Amendment protects "access" to such "commercial goods."
Can't have that.
Duncan Frissell writes: "What new freedoms? In 1789 Americans had the right to ingest anything they could find or produce (unless they were Indians)." If alcohol consumption was unregulated in the 18th century, that's news to me. If the right to ingest whatever one could find or produce is an entitlement as a matter of substantive due process, then all sorts of laws are unconstitutional.
It seems like Duncan didn't read the opinion. The court notes:
That said, terminally ill people present a special case, because they don't care whether a drug is "safe" or not if it provides the only hope of a cure.
The problems with letting terminally ill people try whatever they want seem to be twofold. First, the government would be precluded from prohibiting even 100% snake-oil products, which doesn't seem right. Second, it's not always the case that no approved treatment would be effective; it's a tragedy if someone dies following an experimental treatment when they could have lived by taking an approved drug.
Now, maybe it's their choice to try the risky, unapproved treatment, but if that's your position then you probably shouldn't support the existence of government safety testing in the first place.
Suppose the drug not only fails to work, but causes the person to be in excruciating pain for the rest of her life, or kills her in 2 weeks instead of her expected 2 years. The drug company's like "yeah, we knew it would do that to someone in her condition, but since we're immune from suit, we saw no good reason to disclose that."
You can imagine further horror stories as easily as I can. Agreed with Steve that the real issue here is whether one opposes FDA regulation, period.
You're running smack into the Commerce Clause, my friends.
The Commerce Clause is just an allocation of government power as between the feds and the states, i.e. it says the feds, not the states, can regulate interstate commerce. Like every other allocation of government power, it's not written as an exception to the Bill of Rights.
As to this case, it does seem to be a policy question more than a constitutional one. I agree drugs for the terminally ill should be on the "super fast track", but that's really for Congress to decide.
I have two problems with this point of view.
First, terminal ill patients are ALREADY subject to lots of "snake oil." With the failure of traditional medicine to cure their disease, patients resort to all manner of alternatives, including much outright quackery. In the absence of effective pain control, patients resort to suicide. Such desparate measures result from the denial of treatment. Allowing additional treatments, even if not perfectly "safe" (e.g. "insufficiently" regulated drugs) or with the risk of addiction is a means to cure the harm.
Second, the concern that lack of government control will lead to rampant abuse ignores the experience of the marketplace. The FCC wants to protect me from nudity; I just change the channel. The FDA wants to protect me from unregulated drugs: if there were more drugs and more information on the drugs that are out there, then I would rationally choose what drug to take. In a related vein, the FDA could provide information, or an opinion on the possible hazards, but leave approval up to the consumer.
Sure, there are risks. But there are also costs to not taking risks.