Alabama lawmakers send Right to Try bill to governor

The Alabama state legislature sent a bill to Governor Robert Bentley that would provide terminally ill patients with access to certain medicines. Senate Bill 357 (SB 357), titled as the Gabe Griffin Right to Try Act, would allow physicians to prescribe terminally ill patients medicines that have passed FDA Phase 1 approval but have yet to be made available for sale. All medications available under the law must have successfully completed safety testing. The governor has six days to sign the legislation into law.

Accessing experimental drugs

Other than clinical trials, which are difficult to qualify for, the FDA has provisions for patients who want to access experimental drugs under its compassionate use process. Only a licensed physician is able to apply for expanded access under a single patient Investigational New Drug Application. The drug manufacturer must still be willing to provide the medicine, as the manufacturer cannot be compelled to provide the investigational product.

Advocates of Right to Try laws argue that the FDA’s approval process is lengthy and time-consuming. Although the FDA does generally approve most compassionate use requests, the paperwork and process can take months that the terminally ill patient may not have. Right to Try laws typically shield physicians, hospitals, and manufacturers from prosecution. Critics of Right to Try laws argue that the state measures are not well-founded, as manufacturers will still be hesitant to look outside of federal requirements, because of supply, cost, and liability issues.

Eligibility

The proposed law would be restricted to patients with a terminal disease that have exhausted all treatment options and cannot enroll in a clinical trial. Eligible patients must have: (1) a terminal illness, attested to by the treating physician; (2) considered all other treatment options approved by the FDA; (3) received a recommendation from his or her physician for an investigational drug, biologic, or device; (4) given written, informed consent for the use of the investigational drug, biologic, or device; and (5) present documentation from his or her physician attesting to the above criteria.

Similar measures

Right to Try laws have already been enacted in 18 states, including Colorado (the first state to enact such a measure), Michigan, Mississippi, Virginia, Utah, and Arizona (see State ballot initiatives put health law in the ballot box, November 5, 2014).