June 4, 2006
Do Terminally Ill Patients Have a Fundamental Right to Get Access to Post-Phase I Drugs?
A divided panel of the U.S. Court of Appeals for the D.C. Circuit answered that question in the affirmative last month in the potentially significant case of Abigail Alliance for Better Access to Developmental Drugs et al. v. von Eschenbach. The plaintiffs (including the Washington Legal Foundation) had sued the FDA to establish the constitutional right of dying patients to obtain investigational drugs without relying upon the two versions of "compassionate use" currently allowed by statute ("single-patient INDs" and "treatment INDs"; see 21 U.S.C. § 360bbb(b) & (c)). After the District Court dismissed their case, the D.C. Circuit reversed. The opinion by Judge Judith Rogers (and joined by Chief Judge Douglas Ginsburg) concluded that previous Supreme Court cases support the plaintiffs' allegation that the right of terminally ill patients to obtain access to investigational drugs implicates a fundamental due process right. Here is the court's summary:
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 life-sustaining medical treatment, id. at 279. Here, the claim implicates a similar right — the right to access potentially life-sustaining 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.
The case goes back to the District Court now so that the court can make findings in light of the strict-scrutiny test that the Court of Appeals said applies to the case. It's not at all clear that the FDA will be able to prevail under this tougher test. For an excellent guide to the decision, the underlying law, and the implications of the D.C. Circuit's decision for the future of clinical drug trials, the food-and-drug lawyers at Covington & Burling have prepared the best summary I've seen. [tm]
June 4, 2006 | Permalink
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