Colorado Governor John Hickenlooper signed a first-of-its kind piece of legislation on Saturday, designed to allow terminally ill patients to access experimental drugs awaiting federal approval.
The law, dubbed “Right To Try,” is one of several being advanced in state legislatures by patient advocates who say they are frustrated by the lengthy FDA approval process for potentially lifesaving drugs. Passed unanimously by the state legislature, the law has also been referred to as the “Dallas Buyers Club” bill, after the movie about an AIDS patient who smuggled experimental drugs from Mexico.
Though there are existing, “compassionate use” guidelines that allow patients access to untested drugs currently awaiting approval, supporters of “Right To Try” laws say that the process, which requires federal approval, is often confusing. According to The Huffington Post, state Sen. Irene Aguilar, who sponsored the bill and is a physician herself, said that those guidelines can be seemingly filled with “insurmountable” obstacles for patients. As previously reported by The Inquisitr, calls for eased restrictions have even come from within the FDA itself.
The proposed laws are an effort to use state-level legislation to circumvent a federal system that has historically sided with drug companies. A federal judge ruled in 2003 that terminally ill patients did not have the right to access experimental treatments, or “investigational medicine.” An appeal in that case was brought as high as the Supreme Court, who declined to consider it.
Skeptics of the measure, however, say that it amounts to little more than a “feel good” campaign, pointing out that the law doesn’t compel drug companies to provide patients with experimental treatments outside of federal regulations. Dr. David Gorski, who edits the blog Science Based Medicine, says that drug companies, which pour millions of dollars into development and the FDA approval process, would withhold access to experimental drugs to protect those investments. According to BuzzFeed, he also pointed out that there are potential drawbacks to the current legislation:
“These proposals are built on this fantasy that there are all these patients out there that are going to be saved if they could just get access to the medicine. In reality, the patients that might be helped are very few, while the number of patients who could be hurt by something like this are many.”
-Dr. David Gorski
Rep. Joann Ginal, who co-sponsored the bill after her brother received experimental treatments for a rare form of cancer, disagreed, saying that terminally ill patients “should have a choice to try every possible drug.” Similar laws await the signatures of Governors in Louisiana and Missouri, while a measure expanding access to experimental drugs will be on the ballot in Arizona this November.