Access to Experimental Drugs for Terminally Ill Patients
- Benjamin P. Falit, JD;
- Cary P. Gross, MD
- Author Affiliations: Section of General Internal Medicine (Mr Falit and Dr Gross) and Robert Wood Johnson Clinical Scholars Program (Dr Gross), Yale University School of Medicine, New Haven, Connecticut.
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- DRUG THERAPY
- DRUG INDUSTRY
- DRUGS, INVESTIGATIONAL
- PATIENT SAFETY
- RESEARCH
- TERMINAL CARE
- UNITED STATES FOOD AND DRUG ADMINISTRATION
Terminally ill patients for whom conventional medicine offers little benefit are often willing to try unproven therapies. Because these individuals are often ineligible for clinical trials and compassionate use can be procedurally difficult to secure, gaining access to experimental drugs is not a viable option for many patients.1 Congress and the US Food and Drug Administration (FDA) have attempted for decades to strike a proper balance between access and oversight, with periodic episodes of heightened awareness that include the AIDS epidemic of the 1980s, breast cancer advocacy in the 1990s, and most recently, Abigail Alliance v Von Eschenbach, a case in which the plaintiffs unsuccessfully argued that governmentally imposed restrictions on access violate the Fifth Amendment's due process requirement.2
After 2 appeals, the US Court of Appeals, DC Circuit, held that due process does not include a fundamental right to access experimental compounds, a ruling that allows …
