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Federal Right To Try Proposal Could Make California Law More Effective
President Donald Trump voiced support Tuesday night for a Right to Try policy, which could help terminally ill patients nationwide more easily access experimental drugs.
California enacted a similar policy in 2017. It allows very sick patients to plea for experimental treatments directly from drug companies, instead of waiting for years for drugs to hit the market or asking the Food and Drug Administration for early access.
But patients and advocates said the bill doesn’t function well without a federal counterpart. As it stands, if someone experiences adverse effects while taking a drug acquired through California’s Right to Try policy, the FDA can pull the treatment from the clinical trial process. The mismatch has made drug companies reluctant to participate.
Democratic Assemblyman Ian Calderon, who authored the state's Right to Try law, said the federal legislation is necessary because the pharmaceutical companies were “not feeling like they had the ability to share these experimental medications that had passed phase one of the process, because of what effect it may have on their overall approval through the FDA.”
Priscilla VanderVeer, spokesperson for the industry group PhRMA, said in an email that patients should use existing FDA channels to access investigational treatments.
“The FDA and institutional review boards should generally approve expanded access to an investigational drug before a biopharmaceutical company can provide it to a patient,” she said. “Further, biopharmaceutical companies should establish telephone or Internet-based information sources to facilitate communication about expanded access programs between a patient’s qualified health care provider and biopharmaceutical companies.”
With a federal version of Right to Try in the works, advocates hope to see more protections for drugmakers. Congress’ latest proposal — which passed the Senate in August — states that federal agencies cannot use outcome data from Right to Try patients while reviewing or approving a treatment, unless that data is critical to determining the safety of the drug.
Trump said during his State of the Union address that he’d like to give terminally ill patients better chances at cures.
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