Why You Can't Use Your Right to Try
Only 2,000 of 13 million seriously ill Americans get expanded access each year.
The 2018 federal Right to Try law and the FDA's Expanded Access pathway were designed to give terminally ill patients access to experimental treatments when approved options are exhausted. In theory, any of the estimated 13 million Americans with serious or terminal illness could request an unapproved drug. In practice, however, the FDA grants only about 2,000 Expanded Access requests per year, despite approving 99% of them within 24 hours. The bottleneck is not the government but the drug companies themselves: they simply don't offer their experimental therapies.
The core problem is a severe risk/reward mismatch for biotech firms. These small companies spend $1–2 billion and a decade to get a drug approved, raising capital in incremental rounds. Treating a patient under Right to Try introduces legal liability, potential investor backlash, and regulatory scrutiny—all with zero financial upside, since companies can only charge at cost. Even the lawyers and administrative costs go unreimbursed. As a result, biotech executives, already risk-averse to survive fundraising, almost never participate, leaving the law largely symbolic.
- Only ~2,000 of 13 million eligible US patients receive experimental treatments per year via Expanded Access, despite 99% FDA approval rates.
- Biotechs face up to $2B in development costs and 10-year timelines, but Right to Try offers no profit—only 'at cost' reimbursement.
- No federal or state law requires companies to provide drugs; investors' fear of bad outcomes blocks access.
Why It Matters
A well-intentioned law fails to deliver because it ignores the economic realities of drug development.