Right to Try Act
on Thursday, February 26, 2015
Rep. David Harris introduces the Right to Try Act. HB 2508 would provide that an eligible patient with a terminal illness who has considered all other treatment options approved by the federal government may obtain and take an unapproved drug. Unapproved drugs and devices included in this limited carve-out of rights for the terminally ill are limited to those that have successfully completed Phase I of a clinical trial and have not yet been approved for prescription or use by the U.S. Food and Drug Administration (FDA).
In almost all cases when a drug or medical device shows promising results in preliminary “Phase I” studies, the FDA will require extensive follow-up studies to be done. These studies, often called “Phase II,” have several goals. If successful, they gather statistical confirmation that the treatment succeeds, learn more about side effects and contraindications, and learn more about why and how the treatment works so that physicians will learn when and where it should be prescribed and who is helped/not helped by it. In many cases, Phase II studies last for years. While Phase II is ongoing, access to a drug or treatment is severely limited – in effect, sharply rationed – by the maker or provider. Patients and care providers have no right to ask that the drug or device be provided to them.
Many believe we should consider carving out an exception from this bar to allow unlimited access to promising drugs, devices, and treatments for patients who are terminally ill. Bills like HB 2508 have been approved by referendum in Arizona and enacted in Colorado and Louisiana.