Right-to-Try Bill Passes in Three States

Terminally ill individuals in Colorado, Louisiana and Missouri will now be able to try experimental drugs or treatments that have not yet been approved by the FDA.

The idea of allowing terminally ill patients access to experimental drugs and treatments is thought to have been inspired by Dallas Buyers Club, a movie about an AIDS patient who smuggles treatments from Mexico because they were not legal in the U.S.

Under the bills, patients that have exhausted every other possible drug or treatment who obtain the permission of a doctor and drug manufacturer may take medications that have passed Phase 1 testing under the approval process by the FDA.

The FDA approval process can take up to seven years or more. Supporters of the legislation maintain that is time terminally ill patients do not have. Aware of this issue, in 2009 the FDA created the “Compassionate Use” program that would provide experimental drug or treatment access to a “patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.”

For many reasons, supporters of the legislation argue that the Compassionate Use program by the FDA is not working effectively.

The Right-to-Try bill is a way for the states, instead of the federal government, to regulate who should be allowed access to experimental drugs or treatments. The laws will give dying patients access to experimental drugs or treatments that could improve their quality of life or even save their lives.

“These laws are based on the fantasy that there are all these drugs out there that are just waiting to help these patients if it weren’t for the jackboots of the FDA keeping it from them,” said Michael Gorski in an interview with Governing magazine. Michael Gorski is a surgical oncologist specializing in breast cancer.

Some critics of the bill say drug manufacturers will have no incentive to participate. Drug manufacturers spend a lot of time and resources to get their drugs or treatments approved by the FDA and participating in right-to-try could pose a threat to their approval. In a separate interview with ABC 7 News in Denver, Dr. Gorski states “the FDA regulates drug development, and this doesn’t do anything to change that.”

Additionally, Governing magazine reports these laws could decrease the number of those willing to participate in clinical trials. Without clinical trials the drugs and treatments cannot help a broader patient population in the future, creating a future concern for public health.

Minnesota and Arizona may consider similar bills in their next legislative sessions.

Tags: