Right to Try vs. Expanded Access: Under the FDA’s Expanded Access Program, patients under certain circumstances can take experiential drugs that have not yet been FDA approved; however, the FDA must sanction their use. The agency says it approves 99% of the more than 1,000 annual requests for experimental drugs requested through the program.
What proponents say
Starlee Coleman, senior policy advisor, Goldwater Institute, says the FDA is the ultimate arbiter of which drugs should be made available. Still, she believes that the FDA approval requirement under the Expanded Access Program is too time consuming (it requires doctor/patient application to the FDA for a single patient investigational new drug treatment and approval from an independent review board), especially for terminal patients.
“We don’t think Americans should have to apply to the government to save their lives,” she says. “The government shouldn’t be able to say ‘no’ if a manufacturer and doctor approve. Right to Try provides access to potentially life-saving treatment for patients without other options who cannot get into a trial.”
Coleman says drugs available through Right to Try have passed phase 1 trials and continue to be tested, making them safe enough for terminal patients while offering possible benefits. “Right to Try could be particularly beneficial if a trial ends with positive results, but a drug has not yet been approved,” she says.
She also emphasizes that Right to Try is voluntary for patients, doctors, and manufacturers.
Next: What opponents say