Terminally ill patients often are frustrated to hear about experimental drugs they think might help them, but have not yet been approved by the Food and Drug Administration — a process that often takes years.
Pushed by state legislators and constituents who were upset that sick family members could not access drugs which have passed the first stage of clinical trials, Colorado Governor John Hickenlooper signed into law the so-called “Right to Try” bill on Saturday. His actions made Colorado the first state to allow patients to work with pharmaceutical companies to access the drugs. Insurance companies are not obligated to pay for the treatment and drug makers do not have to agree to comply.
“When you’re terminal and there’s a drug out there that might help you, it can seem that the obstacles to get that drug are insurmountable,” state Sen. Irene Aguilar, a physician and bill co-sponsor, said. Aguilar had taken to calling the legislation the “Dallas Buyers Club” bill, taken from the 2013 film that adapted the story of an AIDS patient who smuggled unapproved pharmaceuticals from Mexico to Texas in order to treat symptoms.
Similar bills have unanimously passed the state legislatures in Missouri and Louisiana, but are awaiting their governors’ signatures. Voters in Arizona will face a ballot issue on a “Right to Try” law in November. Although the bills have had strong bipartisan support, they have been based on model legislation designed by the Goldwater Foundation, a conservative public policy advocacy and research group which has been trying to reduce the FDA’s power.
There are skeptics, however. In the blog Science Based Medicine, surgical oncologist Dr. David Gorski worries that the laws could do more harm than good. He points out that “most investigational drugs that make it past phase I trials still end up failing … only 5% of all cancer drugs that enter clinical testing are ultimately approved for patient use.” Gorski is concerned that chasing after these investigative drugs diverts people from clinical trials or palliative care.
Although state laws cannot supersede federal policy, a similar law has been introduced into the House of Representatives. According to the Library of Congress, the Compassionate Freedom of Choice Act of 2014 “Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patient.” Gorki says the bill would also not require drug companies to track the impact of any such experimental treatments that are tried. The bill has been referred to the Subcommittee on Health.