Expanded Access, Right to Try, and Ethical Considerations

Question 1

approved drugs

Answer 1

passed clinical trial, labeled, and reimbursement possible through a 3rd party

Question 2

Clinical trials

Answer 2

data collected on safety and efficacy, most efficient path to the public market

Question 3

Expanded access

Answer 3

opportunity when other drug options are exhausted, goal is access for treatment
EUA
last resort
decided y FDA
lack of safety and efficacy data

Question 4

Right to try act

Answer 4

eligible patients have access to eligible investigational drugs

Question 5

Patient conditions for right to try

Answer 5

life threatining disease
exhausted approved options
unable to participate in trial
informed consent

Question 6

Drug conditions for right to try

Answer 6

past Phase I
unapproved for any use
active IND
ongoing development