AUSTIN (KXAN) — A bill filed Monday in the Texas Senate could make it easier for terminally ill patients to get access to potentially life-saving medication. The Andrea Sloan Right to Try Act would eliminate the 30-day waiting period at the Food and Drug Administration after a pharmaceutical company voluntarily gives an otherwise terminally-ill patient access to a safe but experimental medication.
This legislation has already passed in five states, including Colorado, Missouri, Michigan, Louisiana and Arizona. It is being considered in an additional 26 states.
The Texas legislation is named for Austin attorney Andrea Sloan, who battled ovarian cancer and waited several months for an experimental drug doctors believed could extend her life. For Sloan, 42, the drug came too late in her battle and she died on Jan. 1, 2014. Sloan was also the executive director of the Texas Advocacy Project, where she provided free legal assistance to victims of domestic violence. At the end of her life she became a vocal advocate for Compassionate Use Reform, an issue KXAN News has covered extensively.
“Time is of the essence when it comes to Compassionate Use,” said Michelle Wittenburg, a close friend of Sloan’s. “An additional wait of several weeks to process an application is very detrimental to a patient in this condition, especially once the physician certifies that the patient is terminal, the patient agrees to sign informed consents, and a pharmaceutical company is willing to give the drug.”
The Texas legislation, authored by Sen. Paul Bettencourt, R-Houston, would not require drug companies to provide an experimental drug and it does not remove the FDA from the compassionate use process. It allows insurance companies to cover the cost of the treatment, but does not require them to do so.
Under SB 694, any drug a physician seeks for compassionate use for a patient must have successfully completed Phase 1 of the FDA’s clinical trial process. This phase is generally known as the “safety” phase, and this provision in the bill ensures that the FDA standards of safety are met and maintained.
Rep. Kyle Kacal, R-College Station, and Rep. Ken King will file this bill in the House of Representatives shortly, and local Rep. Eddie Rodriguez will be a joint author.