May 3, 2006
A Right To Unapproved Drugs?
The Abigail Alliance for Better Access to Developmental Drugs (“the Alliance”) seeks to enjoin the Food and Drug Administration (“FDA”) from continuing to enforce a policy barring the sale of new drugs that the FDA has determined, after Phase I trials on human beings, are sufficiently safe for expanded human testing (hereafter “post-Phase I investigational new drugs”). More specifically, the Alliance seeks access to potentially life-saving post-Phase I investigational new drugs on behalf of mentally competent, terminally ill adult patients who have no alternative governmentapproved treatment options (hereafter “terminally ill patients”). The Alliance contends that the FDA’s policy violates the substantive due process rights to privacy, liberty, and life of its terminally ill members. The complaint presents the question of whether the Due Process Clause protects the right of terminally ill patients to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational new drugs that the FDA has yet to approve for commercial marketing but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing on a substantial number of human beings.
Upon applying the Supreme Court’s test for addressing substantive due process claims set forth in Washington v. Glucksberg, 521 U.S. 702, 710 (1997), we hold that the district court erred in dismissing the Alliance’s complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. First, the right at issue, carefully described, is the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient. Second, we find, upon examining “our Nation’s history, legal traditions, and practices,” Glucksberg, 521 U.S. at 710, that the government has not blocked access to new drugs throughout the greater part of our Nation’s history. Only in recent years has the government injected itself into consideration of the effectiveness of new drugs. Third, Supreme Court precedent on liberty indicates that the right claimed by the Alliance can be inferred from the Court’s conclusion in Cruzan v. Director, Missouri Department of Health, 497 U.S. 261, 278 (1990), that an individual has a due process right to refuse lifesustaining medical treatment, id. at 279. Here, the claim implicates a similar right — the right to access potentially lifesustaining medication where there are no alternative government-approved treatment options. In both instances, the key is the patient’s right to make the decision about her life free from government interference.
Update: Still haven't read all of it, but enough of the conclusion to observe that the main conclusion is that the district court is to evaluate the FDA's conduct under the "narrowly tailored" test. A commenter suggests that this is a fairly limited ruling; since I don't know that much about how the compassionate use process is today, it's hard for me to evaluate.
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Once you read the whole opinion, you'll know how limited this right actually is. If upheld, it will force the FDA to make the path to compassionate use less arbitrary, which the patient and research communities, just last month, asked it to do anyway.
Posted by: Paul P | May 3, 2006 10:50:25 AM