Court Rejects Terminally Ill Patients’ Chance to Live, Upholds FDA Red Tape

by Hans Bader on August 7, 2007

in Healthcare, Legal, Personal Liberty, Precaution & Risk

The D.C. Circuit Court of Appeals has ruled 8-to-2 in Abigail Alliance v. Von Eschenbach that terminally ill people cannot challenge the FDA’s ban on drugs that have passed an initial safety review, but have not yet completed the FDA’s entire, years-long clinical testing process. The court’s opinion 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.”

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 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.”

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