Sponsor of Clinical Drug Trial Not Required to Continue Providing Drug to Participants After Termination of the Study

The Sixth Circuit in the case of Abney v. Amgen, Inc. has affirmed the district court’s denial of the plaintiffs’ request to order Amgen to continue to provide an investigational drug. The plaintiffs participated in a clinical trial of a drug to treat Parkinson’s disease. They filed suit against Amgen after its announcement that it was terminating the study based on safety concerns. Plaintiffs argued that Amgen was legally obligated to continue administering the drug to them.

The Sixth Circuit ruled that the trial court was correct in determining that the Informed Consent form was not evidence of a contract between Amgen and plaintiffs, because neither Amgen nor its agents signed that document. The court also found that there was no evidence of a promise by Amgen to continue providing the drug to plaintiffs after the termination of the clinical trial, or an agreement that the sponsor would be acting primarily to benefit the plaintiffs.

In language that should be of concern to institutional review boards, the court did say that “[a]lthough we express no ultimate view, it appears that the plaintiffs might have considered suit against” the institutional review board (IRB) and the investigators involved in the study, and that the IRB “did a poor job informing the plaintiffs as to the grounds upon which the study would terminate and their access to [the drug] would be denied.” The court further “urge[d]” IRBs “to take additional measures to ensure that patients fully understand that even if they or their physicians believe an experimental treatment to be safe and efficacious there may be circumstances under which they will be denied continued access to treatment.” Sponsors should be aware that these dicta may lead IRBs to modify their template language in future consent forms.

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