Abigial Alliance v. FDA US District Court of Appeals, DC Circuit
The US District Court of Appeals for the D.C. District yesterday published its opinion in Abigail Alliance v. FDA/HHS. Abigail Alliance seeks to broaden access to experimental drugs for terminally ill patients. They seek unfettered access to experimental drugs after Phase 1 for terminal conditions (the Alliance would have the patient’s doctor make the determination whether the condition is terminal). The Court’s opinion is attached. The Appeals Court ruled 2 to 1 to remand the case to the District Court for trial (the Court had earlier dismissed the case), citing the terminally ill patient’s right to due process under the Constitution as a basis for contesting FDA’s restricted access to such medicines.
The minority opinion, by Judge Griffith, disagrees with the due process argument: “Our Nation’s concept of ordered liberty, along with our traditions and history, do not call for courts to usurp the judgment of the scientific and medical communities, expressed through Congress and the Executive Branch, that science does not warrant allowing the early access to experimental drugs the Alliance demands.”
The decision also raises a host of practical issues to be faced by the District Court in applying the due process standard. Again, from Judge Griffith: “If a terminally ill patient has such a right, are patients with serious medical conditions entitled to the benefit of the same logic and corresponding access? If an indigent cannot afford potentially life-saving treatment, would the Constitution mandate access to such care under the right recognized by the majority? Can a patient access any drug (i.e., marijuana for medicinal purposes…if she believes, in consultation with a physician, it is potentially life-saving? Would the majority’s right guarantee access to federally-funded stem cell research and treatment? Perhaps most significantly, what potential must a treatment have in order for the Constitution to mandate access? Because the majority does not answer this last question, the District Court faces an impossible task on remand. The majority concludes that the District Court must ‘determine whether the FDA’s policy barring access to post-Phase I investigational new drugs by terminally ill patients is narrowly tailored to serve a compelling governmental interest…..’ As a preliminary matter, the majority never explains why the District Court must determine that the FDA has a compelling, narrowly tailored interest in preventing access to all [Court’s emphasis] drugs that have passed or will pass Phase 1. Under the majority’s facial approach, the District Court must examine every drug undergoing FDA testing and every drug that may ever undergo FDA testing. It must then evaluate whether the FDCA’s prohibition on access to unapproved drugs and corresponding exemptions for limited access serve a compelling interest and are narrowly tailored in light of all of the different potential risks and benefits of all experimental drugs and the needs of all terminally ill patients.”
Another potential practical concern of a presumed forthcoming District Court ruling, not mentioned by Judge Griffith, is this: If FDA retains the full ability to regulate access to experimental drugs for life-threatening conditions from Phase 1 and earlier in development but loses its full ability to regulate access beyond Phase 1, how does FDA react and what are the implications for the terminally (or seriously) ill? Well, if FDA’s interests do not change, and there is no reason to think they would, it reacts to such a ruling by tightening it’s requirements for advancement to and passage through Phase 1, requiring a higher level of certainty of a drug’s safety and some evidence of clinical efficacy before approving advancement to Phase 2. After all, clinical testing phases are rather loosely defined statutorily (see 21CFR 312.21(a)). There’s little to stop FDA from tightening access by creating higher evidence hurdles. This worries me greatly, because these higher hurdles could dampen innovation broadly (note that most of these medicines are under development by very small firms that can ill-afford higher evidence hurdles) and actually have the effect of diminishing timely access to new, promising medicines for life-threatening conditions. My unsolicited advice to the Abigail Alliance is to keep FDA access to medicines policy out of the hands of the courts and put it back into the political realm. It’s a longer road, but it leads to a better place.
