Four States Introduce Legislation on Right to Try Experimental Drugs
- By BSTQ Staff
Several states have introduced legislation that would let patients bypass the U.S. Food and Drug Administration’s (FDA) Expanded Access program in acquiring investigational therapies. FDA’s program allows terminally ill patients to use experimental drugs in certain cases; however, patients and physicians wishing to try experimental drugs as a last-ditch effort to prolong life must first get FDA approval. The four recently introduced bills in Colorado, Louisiana, Arizona and Missouri would grant terminally ill patients access to post- Phase-I experimental drugs without having to go through the agency.
According to Arthur Caplan, director of medical ethics at New York University, “There are people who still do encounter trouble getting through the FDA [with their requests]. Sometimes the paperwork can seem onerous, and sometimes the doctor isn’t sure what to do.” However, even if patients make it through the application process, “the drug company is under no obligation to release the experimental drug,” adds bioethicist Yoram Unguru in the Johns Hopkins Bioethics Bulletin. Additionally, even if the state laws are passed, they are superseded by federal laws.
