Abigail Alliance v. FDA

Abigail Alliance for Better Access to Developmental Drugs (the Alliance) was an organization that advocated for an expanded access for terminally ill patients of experimental drugs that weren’t yet approved by the Food and Drug Administration (FDA), due to the fact that the drug approval process required clinical trials of three to four phases to be conducted on human subjects which took years to complete and continue with the drug application process.

Under the Food, Drug and Cosmetic Act (the Act) and FDA Regulations promulgated pursuant to the Act, certain programs such as the Treatment Investigational New Drug (treatment IND) program had been developed to make experimental drugs accessible for the treatment of extremely serious and life threatening conditions like that of extremely ill patients subject to approval by the FDA of the request to such effect. The FDA would deny the request for treatment IND if it couldn’t reasonably conclude that the drug was effective or if it believed that such treatment would expose patients to a risk of illness or injury.  The Alliance submitted its request for the FDA with citizens’ petition stating that the patients (who were to be treated with the drug) were terminally ill and had no alternative treatment, and the delay in the drug approval process was more fatal for them than the risk they would have had to assume while taking the experimental drug. The Alliance submitted that as long as the drug met a certain level of safety and efficacy (phase 1 of the trial process), terminally ill patients had to be given the access to use it and to this end, the FDA had to come up with new regulations that would authorize such use. The FDA responded to the request stating that there had been conflicting opinions in the medical community and in the public regarding early access to drugs that to accept the Alliance’s suggestion would disturb the balance the FDA had been trying to strike between early access and requirements of safety and efficacy.

The Alliance brought its claim before a lower court arguing that the United States Constitution provided for a right to access to experimental drugs for the members of the Alliance and the time it took to comply with FDA’s clinical trial requirements led to the death of the patients while the exceptional circumstances by which drugs could be made accessible to terminally ill patients were very small. The fact that drug sponsors were prohibited from making profit for providing experimental drugs available to terminally ill patients made the problem worse by preventing sponsors from participating in the pre-approval treatment. The Alliance argued that terminally ill patients had the right to assume the risk involved in trying unapproved drug under the Constitution.

The lower court held that there was no such right to access unapproved drugs under the Constitution. It further held that mentally capable terminally ill patients could have access to INDs  once the drug had passed Phase 1 clinical trials if there were no alternative treatments approved for the condition/the disease concerned. The court noted that such expanded access protected rights under the due Process Clause of the Constitution.

The Alliance appealed to the United States Court of Appeals (the court) from the lower court’s decision. The appellants submitted that FDA’s regulations (ones prohibiting patients’ access to a drug that was not approved to be effective for use and manufacturers from making profit on the sale of their unapproved drugs) had to scrutinized as they had interfered with patients’ constitutional rights. They had claimed that physicians and patients were autonomous in evaluating whether a medical treatment was effective pursuant to American common law and practices. They also stated that FDA’s position wasn’t in compliance with the way the American legal tradition had treated people in other dangerous situations. They argued that “the concepts of self-defense, necessity and interference with rescue” [Page 14] included the right for terminally ill patients to seek a treatment that could save their lives despite lack of legitimacy in doing the same and prevalence of risks to health.

The court noted that the Alliance failed to take in to consideration that a drug couldn’t be administered at experimental stage because both its safety and its efficacy hadn’t been ascertained. It also pointed that the Alliance should have demonstrated the fact that there had been a tradition of expanding access to drugs that hadn’t been proved to be both safe and effective. The court also noted that the Nation’s history, legal tradition and practice tended to regulation of the safety and efficacy of drugs.

The court dismissed the appellants’ argument that patients could make individual decision on whether a drug was effective before 1962 when efficacy tests began to be applied to drugs; It stated that the argument had ignored the fact that the Nation had a history of regulating safety of drugs before the application of efficacy requirements. The court held that drugs couldn’t be used for treatment only because they had passed phase 1 of clinical studies as the latter couldn’t warrant a drug’s use for the treatment of terminally ill patients. It also pointed that FDA’s regulation was consistent with the Nation’s tradition of regulating the safety of drugs.

Regarding appellants’ argument based on the defense of necessity, the court held that Congress had already eliminated such a defense by generally prohibiting access to investigational drugs and thus rejected the argument. In relation to the Alliance’s argument on interference with life saving efforts, the court rejected it stating that the concept couldn’t correctly be interpreted to give a right that weighed against scientific justifications supporting FDA’s requirement of clinical studies on drugs. Regarding the self-defense argument the Alliance had raised (the argument that the self-defense concept justified access to treatment the same way it justified the use of force by an assault victim), the court held that the concept couldn’t apply to the case at hand as this case was about the right to assume risks and not about use of force to defend oneself or to access a life saving treatment. [Page 28]; the court rejected the argument as not supported by the notion of self-defense.

The court examined the Alliance’s right to access claim on the basis of ‘rational scrutiny’. [Page 32] The court reiterated the decision in United States v. Rutherford, 442 U.S. 544 (1979) where the Supreme Court stated that an unapproved drug wasn’t safe for everyone including terminally ill patients that its risks couldn’t be offset by their potential benefit. Accordingly, the court held that the government’s interest (the FDA’s policy in restricting access to experimental drugs) was rationally related to a legitimate interest of the state protecting the public from unsafe and ineffective drugs.

The court affirmed the lower court’s judgment.

“Although terminally ill patients desperately need curative treatments, as Rutherford holds, their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit.  Thus, we must conclude that, prior to distribution of a drug outside of controlled studies, the Government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug.” [Page 34]

“Our Nation’s history and traditions have consistently demonstrated that the democratic branches are better suited to decide the proper balance between the uncertain risks and benefits of medical technology, and are entitled to deference in doing so.” [Page 35]

“We must assume that, when the statute in question was passed, the legislature . . . was not unaware of these opposing theories, and was compelled, of necessity, to choose between them.  It was not compelled to commit a matter involving the public health and safety to the final decision of a court or jury.  It is no part of the function of a court or a jury to determine which one of two modes was likely to be the most effective for the protection of the public against disease.” [Page 35]