Patient access to unapproved therapies: the leading edge of medicine and law.
In 2007, the United States Court of Appeals for the District of Columbia rejected a claim that terminally ill patients have a constitutionally protected right to access experimental drugs that have passed Phase I testing, but have not yet received FDA approval. Since that case was decided, patients and patients' rights groups have continued to advance both constitutional and common law claims in an effort to compel FDA and manufacturers to grant access to unapproved therapies. Congress and FDA have also advanced proposals that would expand patient access to drugs that have not yet passed through Phase III trials. Whether patients with serious and life-threatening illnesses should be allowed to obtain experimental therapies before FDA approval is an issue that is poised to shape the practice of both law and medicine in the United States for some time to come.
Romano
Leah Voigt
LV
Hall, Render, Killian, Heath & Lyman, PLLC, Troy, Michigan, USA. lromano@hallrender.com
Jacobson
Peter D
PD
D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D028701:Patient Rights / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration