Colo. gives terminally ill access to investigational treatments

This week, Colorado likely will become the first state to allow terminally ill patients access to drugs and devices not yet approved by the Food and Drug Administration.

The bill, and similar ones being considered in other states, raise questions about whether allowing broader access to treatments not yet determined safe or effective puts patients at risk and could increase costs without corresponding health benefits.

The so-called “Right to Try” bill, expected to be signed into law by Gov. John Hickenlooper, would allow drug and device manufacturers whose products are still in the investigational stage to offer those therapies to terminally ill patients once those products have completed Phase 1 clinical trials. Pharmaceutical companies would not be required under the law to provide investigational drugs or devices, nor would insurers be required to cover the costs.

The FDA already allows access to investigational therapies for terminally ill patients outside of a clinical trial under expanded or “compassionate” use on a case-by-case basis. But critics say FDA permission is granted only after a lengthy review process.

State legislators in Missouri and Louisiana have proposed similar bills. In Arizona, the Legislature recently approved a ballot initiative, and voters will decide on the issue in November.

Last month, U.S. Rep. Morgan Griffith (R-Va.) introduced a bill to prohibit the FDA from preventing the “manufacture, importation, distribution or sale of investigational drugs or devices” for terminally ill patients. According to the legislation tracking website GovTrack.us, the bill was rated as having a 3% chance of enactment.

Follow Steven Ross Johnson on Twitter: @MHsjohnson