In President Trump’s first State of the Union address, he challenged Congress to give people who are terminally ill immediate access to experimental treatments without going through the FDA. A number of states have already passed such “right-to-try” laws. The Senate has passed a federal version, and a revised version is now under consideration in the House, with a vote likely on Tuesday.

Backers of the right-to-try law would have you believe that the FDA is barring the distribution of all sorts of miracle cures. But many experimental treatments turn out to be totally ineffective. And as it stands, the FDA approves more than 99 percent of the thousand-plus applications it gets each year — usually within days of receiving the application — for access to experimental therapies through an existing program called expanded access or compassionate use.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

  • This is a key point that needs to be highlighted: good policy is often negated by bureaucrats and bureaucratic processes. “FDA approves 99%!” What good is approval if it comes too late?

  • Your article doesn’t mention that it can take a physician up to 100 hours to ask the FDA for permission for expanded access/compassionate use. Few physicians are willing to spend that much time for a single patient. Even if the FDA ultimately approves the application, it can take months to do so, which is a long time for someone who is terminally ill. That’s why Right to Try is needed.

    • This is a key point that needs to be highlighted: good policy is often negated by bureaucrats and bureaucratic processes. “FDA approves 99%!” What good is approval if it comes too late?

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy