Right to Access Experimental Drugs: Terminally Ill Patients Have the Right to Access Experimental Drugs Pending Final FDA Approval-Abigail Alliance V. Von Eschenbach
Anderman, Jonathan, American Journal of Law & Medicine
Right to Access Experimental Drugs: Terminally Ill Patients Have the Right to Access Experimental Drugs Pending Final FDA Approval-Abigail Alliance v. Van Eschenbach, 445 F.3d 470 (B.C. Cir. 2006).
Equitable Relief under ERISA: Supreme Court Allows a Fiduciary to Recover Expenses Paid to a Beneficiary Who Subsequently Recovered Damages from a Third Party in a Tort Action Lawsuit-Serebojff v. Mid Atlantic Medical Services, 126 S. Ct. 1869 (2006).
Right to Access Experimental Drugs: Terminally Ill Patients Have the Right to Access Experimental Drugs Pending Final FDA Approval Abigail Alliance v. Von Eschenbach1 - The United States Court of Appeals for the District of Columbia Circuit recently held that terminally ill patients have a due process right to access potentially life-sustaining drugs that the Food and Drug Administration ("FDA") has approved as safe for expansive testing on human subjects, but has not yet approved to be commercially marketed.2
The FDA has the exclusive authority, under the Food, Drug, and Cosmetic Act ("FDCA"),3 to approve new drugs before they are brought into the interstate market.4 The FDCA instructs the FDA to create standardized rules for approving these new drugs.5 Under this authority, the FDA has promulgated a three-phase requirement for the testing of new drugs.6 Phase I involves the testing of the experimental drug on twenty to eighty human subjects to determine potential side effects and safety for further human testing.7 Phase II focuses more on the effectiveness of the drug while also evaluating further safety risks by testing the drug on several hundred human subjects.8 Finally, Phase III involves the testing of the drug in expanded trials on thousands of human subjects.9
The Abigail Alliance for Better Access to Developing Drugs ("Alliance") submitted a proposal to the FDA encouraging new regulations to give terminally ill patients access to investigational drugs that have only passed Phase I testing.10 The FDA rejected the proposal and the Alliance submitted a Citizen Petition, pursuant to 21 C.F.R. § 10.30, challenging the PDA's policy forbidding the sale of experimental drugs to terminally ill patients before all three phases of testing are completed.11 The FDA received the petition and did not respond within 180 days, thus enabling judicial review of the challenged policy.12 The Alliance filed suit in the United States District Court for the District of Columbia seeking to enjoin the FDA from following its policy barring the sale of drugs to terminally ill patients before completion of all three phases of testing.13 The district court dismissed the complaint for failure to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure,14 and refused to recognize a terminally ill patient's right to receive medical treatment under the Federal Due Process Clause.15 Concluding that no such right exists, the district court found the FDA policy was rationally related to a legitimate government interest.16
The Court of Appeals for the D.C. Circuit began its assessment by examining how due process claims are evaluated.17 The Due Process Clause "guarantees more than fair process" and accords substantive protection of ensured rights.18 The Court specified two approaches the United States Supreme Court has used in determining the existence of a fundamental right.19 First, a court may find a fundamental right "by probing what 'personal dignity and autonomy' demand."20 Second, a court may find a fundamental right from the Nation's history and legal tradition.21 The Court pointed out that the latter approach, taken from Washington v. Glucksberg,22 is the more restrictive of the two analyses.23 Accordingly, if Glucksberg warrants protection of a new constitutional right, it need not be analyzed under the standard of "personal dignity and autonomy."24 With this in mind, the Court evaluated the case under the two "features" of the Glucksberg standard: 1) inquiring whether the fundamental right is "objectively, 'deeply rooted in this Nation's history and tradition,'"25 and "implicit in the concept of ordered liberty, such that liberty nor justice would exist if [it] were sacrificed,"26 and 2) providing a "careful description of the fundamental liberty interest. …