Table 1.

Comparison of patient rights under US Food and Drug Administration (FDA) expanded access program and Right-to-Try law

Patient concerns	FDA expanded access	Federal “Right-to-Try”
Access to investigational agents	Drugs, biologics, and medical devices	Drugs only
Investigational agent—phase of development	Any stage	Successfully completed phase I
Ethics review	Required. IRB serves as impartial third-party and patient advocate	Not required
Accountability	Physician (investigator/sponsor-investigator) obtains IRB approval, informed consent, reports adverse events, maintains accurate case histories, drug disposition records, and at the end of therapy submits a summary report to FDA. 21 CFR 312.05(c); 21 CFR 312.10(c)(1)	Physician obtains informed consent
Informed consent	Meets federal standards per 21 CFR 50(B) and is reviewed by experienced IRB to ensure requirements are met	No standards stated nor review required
Investigational agent information	Investigator’s brochure (meets standards of 21 CFR 312.23(a)5 and ICH E6(R2))	Not addressed
Financial responsibility	Reviewed by IRB and FDA (in the case of charging for the investigational agent)	Not addressed
Site	Follows established workflow per institution	Not addressed
Conflict of interest	Reviewed by independent IRB for coercion, exculpatory language, and financial conflict of interest	Not addressed
Safety reporting to FDA	IND holder is required to report adverse events to FDA	Not required

IRB, Institutional Review Board.