Despite political support, state right-to-try bills show no takeup
California Gov. Jerry Brown’s veto last week of a “right-to-try” bill disappointed advocates who want more state laws allowing terminally ill patients access to experimental drugs.
Since the spring of 2014, 24 states have enacted right-to-try laws that promise to help dying patients cut through bureaucratic red tape to get drugs not yet approved by the Food and Drug Administration.
But a Modern Healthcare survey found no evidence of any patients receiving an experimental therapy as a result of the new statutes, so far. A spokeswoman for the Louisiana State Medical Society said the organization has received only two requests from patients seeking information. Officials in other states said they have not been contacted by physicians, who would by law be the ones asking pharmaceutical companies for the drugs. Also, no state has yet created the policies or infrastructure to help doctors navigate the right-to-try option. States say they’re working on it.
Some see the lack of action as proof that the laws are based more on politics than helping patients. The libertarian organization behind the campaign says this is only the beginning.
“There are numerous people around the country who are getting ready and preparing,” said Kurt Altman, director of national affairs for the Phoenixbased Goldwater Institute. The insti- tute helped draft the right-to-try bills for state legislatures, which were more open to the legislation than Congress.
Altman said the institute is helping state regulators and medical boards in Arizona and a couple of other states to “enact any regulations that are required to help facilitate (these laws).”
The institute’s goal is to push federal legislation that would allow dying patients to seek experimental drugs without regulatory interference. Under right to try, terminally ill patients who have exhausted all other approved treatment options could request a prescription for an experimental drug or medical device that has passed Phase 1 of the FDA’s clinical trial process. Pharmaceutical companies are not legally required to provide the drug and are not liable if a drug causes harm or death. Few have come out in support of the law.
Sascha Haverfield, vice president for scientific and regulatory affairs at Pharmaceutical Research and Manufacturers of America, the trade group that represents drug companies, said he worries the laws could negatively affect clinical trials. Patients might be less willing to participate because they might be assigned to a control group that gets a placebo. Haverfield said companies have responded to the request for experimental drugs by facilitating awareness of expanded access programs.
There’s also a similar current FDA process called “compassionate use.”
Proponents of right to try say that FDA process, which could take months, was not helpful to those with only a few months to live. The FDA acknowledged delays, and in February issued draft guidance for a simpler application form, cutting the amount of time it takes physicians to complete it from 100 hours to 45 minutes.
Still, “expedited on a federal level is not expedited when these folks need it,” Altman said. Critics say right-to-try laws impede the current federal program.
“I think that politically, (right to try) has been seen as a very positive and proactive thing to support,” said Alison Bateman-House, a postdoctoral fellow at New York University Langone Medical Center’s Division of Medical Ethics. But, she argued, “There seems to be some sort of willful blindness to seeing whether it works or not.”
None of the laws address what some say is a huge barrier to receiving drugs: cost.
Right-to-try laws do not require health insurers to cover experimental treatment or any subsequent care that may occur as a result of taking an experimental drug.
Insurers typically do not cover the cost of experimental treatments, said Courtney Jay, a spokeswoman for America’s Health Insurance Plans, who said the organization is still reviewing right-to-try laws to assess their potential impact.
Haverfield said the solution for terminally ill patients might be in the proposed 21st Century Cures Act, which passed in the House this summer. That would require companies to provide the FDA with more information on how they handle requests for investigational drugs through compassionate use.
GOP lawmakers have also introduced legislation that would prevent federal action to block state right-to-try laws, but the outcome of that bill is uncertain. So far, there has not been a push to create a federal rightto-try law.
That’s why, Altman said, the institute will continue its campaign. He expected Gov. Brown’s veto of a rightto-try bill will only embolden others to eventually get the bill passed.
“Our strategy is not going to change,” Altman said.