1. There *is* a downside to allowing free contract between patients and drug companies. That downside is disruption of an orderly process that identifies from the chemicals tested the few safe, effective agents and discards the many toxic or ineffective agents. Disruption of the FDA testing process by allowing use of drugs that have survived Phase 1 testing would delay or abort identification of useful agents that actually are effective cancer chemotherapy drugs. Such disruption would harm a vast, though somewhat inchoate, class of people who will get cancer and would benefit from identification of useful drugs. This population has rights as well. It is probably true that the current cancer drug approval program will deliver a greater benefit to tmore cancer patients than would release of post-Phase 1 agents. It seems to be a narrowly structured to serve the important government interest of identifying effectivce treatments for cancer.

2. Assuming, arguendo, a right to self defense that encompasses some sort of right of patients to access treatment, Abagail is be a bad case to assert that right. First, substances that survive Phase I screening are not “safe.” Rather, they are safe enough to be used in further testing at the dose identified in the Phase 2 trial. Many of these substances are subsequently found to be too dangerous to use clinically. Second, the vast majority of these agents are not “drugs,” if drugs are agents that provide a therapeutic effect. The vast majority are found not to be effective. Rather, they are chemicals that have a finite but small chance of possessing properties that would allow them to be used as drugs. The FDA has a program to systematically demonstrate or refute the possibility that these substances are drugs. Agents that survive Phase 2 testing are better suited to test Mr. Bader’s proposition.

3. The analogy to abortion is weird. Termination of pregnancy, (whether or not you think is appropriate) clearly has the effect on the mother and fetus that the mother and doctor intend. It is a widely used procedure whose effects and complications are well understood. A better analogy would be whether a doctor should be allowed to give a pregnant woman, for the purpose of terminating her pregnancy, a chemical that had been used in a few hundred rodents and feser than 50 people (in escalating dosages). It is stipulated that the agent didn’t kill the 3 to 5 people who received it at the proposed dosage, and that succeeded in aborting some pregnancies in some of the rodents. That is what these Phase 1 agents comprise.

–Allan Jacobs

Why, then, don’t women have the liberty to contract voluntarily with doctors to remove an unwanted fetal parasite?

The idea that terminally ill people, who are going to die anyway, can be prevented from voluntarily contracting with a drug-maker to buy an experimental drug that is their last, best hope for survival (and has passed an initial safety review) is bonkers, and would have struck the founding fathers as ludicrous and government despotism run amok.

The Court’s opinion eviscerating the right to live is fully of shoddy reasoning. The Court claims its decision does not infringe patients’ constitutional right to life, even though the FDA bans drugs that doctors view as the last, best hope for their patients, because “the collective judgment of the scientific and medical community is expressed through the FDA’s clinical testing process.”

As former FDA official Henry Miller has noted, survey after survey has shown that doctors think the FDA is too slow in approving drugs, as critics of the court’s decision have noted. Doctors emphatically DO NOT view the FDA’s ponderous processes as reflecting the “collective judgment of the scientific and medical community.”

Indeed, the plaintiffs submitted affidavits from doctors that promising drugs existed for their patients that the FDA was blocking, making their patients’ death inevitable. The court ignored these affidavits, and similar allegations in the plaintiffs’ complaint, in granting a motion to dismiss their challenge (which was contrary to Rule 12(b)(6)).

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.

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 use their own money 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 from willing sellers. 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.”

The plaintiffs didn’t seek welfare or any affirmative entitlement from the government. All they sought was the right to voluntarily contract with private sellers to obtain life-saving drugs.

Conservatives on the Court are generally hostile to the creation of new rights, especially when they interfere with the operations of a pro-typically technocratic administrative agency in a situation where Congress has the power to act. So they have no reason to grant certiorari in order to reverse the D.C. Circuit, and hearing a case that affirms the status quo would likely be considered a waste of time on a small docket.

Liberals on the Court, knowing that to grant cert is likely to affirm the D.C. Circuit, have no reason to prevent the law from evolving in other circuits.

Proponents of “a right to save one’s life” would have a stronger case in, for example, a defense to a controlled substances act or unlicensed practice of medicine prosecution involving an experimental drug or procedure that was working at the time, than in this case. This case really involves a right to have the government get out of the way of third party efforts to invent drugs with which you could save your life, notwithstanding a regulatory scheme that has some rational basis, which is a considerably more attenuated matter.