Legal analysis from Dean's Law Dictionary will be displayed here.

This section contains the nature of the case and procedural background.

P is an organization of terminally ill patients and their supporters that seeks expanded access to experimental drugs for the terminally ill. Under the Food, Drug, and Cosmetic Act, no drug may be approved without a finding of 'substantial evidence that the drug will have the effect it purports or is represented to have. It takes about seven years to get a drug approved for use and up to four phases. Although gathering data on effectiveness may be part of Phase I, its primary focus is to determine whether the drug is safe enough for continued human testing. At any time during clinical trials, a drug sponsor is required to notify the FDA of 'any adverse experience associated with the use of the drug that is both serious and unexpected.' Congress has directed the FDA to establish 'scientific advisory panels' to 'provide expert scientific advice and recommendations to the Secretary regarding a clinical investigation of a drug or the approval for marketing of a drug. The FDA and Congress have created several programs designed to provide early access to promising experimental drugs when warranted. The FDA reserves the right to deny any treatment if itbelieves there is no 'reasonable basis' to conclude that the drug is effective; or (2) granting the request “would . . . expose the patient . . . to an unreasonable and significant additional risk of illness or injury. The drug’s sponsor may not profit from any pre-approval treatment program and may only 'recover costs of manufacture, research, development, and handling of the investigational drug.' P submitted its own proposals to the FDA arguing that there is a 'different risk-benefit tradeoff facing patients who are terminally ill and who have no other treatment options.' P contends that termailly ill patients 'should have the ability to opt for a new treatment that has met a lower evidentiary hurdle with respect to safety and efficacy.' The FDA never responded to P's citizen petition. The FDA concluded that accepting the Alliance's proposal 'would upset the appropriate balance that [it is] seeking to maintain, by giving almost total weight to the goal of early availability and giving little recognition to the importance of marketing drugs with reasonable knowledge for patients and physicians of their likely clinical benefit and their toxicity.' P sued D arguing that the United States Constitution provides a right of access to experimental drugs for its members. P argued that 'terminally ill patients,are typically willing to assume risks . . . .' and that the Constitution guarantees them the right to do so. The district court held that 'there is no constitutional right of access to unapproved drugs.' A divided panel reversed, concluding that 'where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient's informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the Due Process Clause.' D appealed the court vacated the decision and granted a rehearing en banc. The court now considers whether the liberty protected by the Due Process Clause embraces the right of a terminally ill patient with no remaining approved treatment options to decide, in consultation with his or her own doctor, whether to seek access to investigational medications that the [FDA] concedes are safe and promising enough for substantial human testing. The court must determine whether terminally ill patients have a fundamental right to experimental drugs that have passed Phase I clinical testing.

The legal issues presented in this case will be displayed here.

The court's holding and decision will be displayed here.