California’s Right to Try law is supposed to give terminally ill patients access to drugs that haven’t been fully approved by the U.S. Food and Drug Administration.
Since it was enacted in 2017 drug companies have been reluctant to participate. A new federal law signed by President Donald Trump Wednesday could solve that problem, but opponents say it will undermine the FDA’s crucial drug-vetting process.
Drugmakers worry that if they give experimental drugs that only have passed the first phase of clinical trials to dying patients and they suffer adverse effects, the FDA will be less likely to approve the drug when it comes time for an official review.
The federal Right to Try law provides broader legal protections for drug companies than the California version does, and limits the FDA’s access to data collected through Right to Try patients.
Naomi Lopez Bauman is director of health care policy for The Goldwater Institute, a free-market organization that helped push through California’s policy and similar laws in roughly three dozen states. “The federal legislation takes a step further in providing protection for liability for manufacturers who would be willing to participate in Right to Try,” she said. “That could go a long way in making manufacturers more comfortable.”
Supporters of the law say it helps patients who are running out of time zip past the FDA’s red tape. But David Magnus, director of the Stanford Center for Biomedical Ethics, said that tape is there for the patient’s own good.
“It gives them a process for doing that that’s vetted, to make it as safe as possible,” he said, “while also promoting what we want as a top priority: which is to actually do the research to find drugs that are safe and effective to give to everybody.”
Magnus worries that if the FDA isn’t overseeing early access to drugs, they won’t be able to track any negative side effects that Right to Try patients experience. He argues that information could be pertinent as the drug moves through the clinical trial process.
The federal law also expands who’s eligible to use Right to Try. California law states that a patient must have just a few months to live. Under the federal policy, anyone with a life-threatening condition who has exhausted all other options can ask for the drugs.