During his first State of the Union address, President Trump urged Congress to pass a bill aimed at giving terminally ill patients access to experimental drugs. As an individual with terminal cancer and a former biotechnology industry executive, I know that the “right to try” isn’t merely a theoretical concept. And while I can relate to patients’ desperate hopes and desires to try new therapeutic approaches, I believe that passage of the federal Right to Try Act would be a disaster.

Right-to-try laws have already been approved by many states. On their surface, they seem to be kind and egalitarian: let terminally ill Americans who have no other options try experimental therapies that haven’t been approved by the Food and Drug Administration. But it’s actually an approach that could do more harm than good for people who seemingly have “nothing left to lose.” I’m also not sure why such a law is needed, since people like me already have access to experimental therapies.

Under the Federal Food, Drug, and Cosmetic Act, patients can seek expanded access, sometimes called compassionate use, to investigational therapies, meaning those that are being studied for safety and effectiveness but that have not been approved by the FDA. Since expanded access was enacted in 2009, the FDA receives approximately 1,000 requests for expanded access each year. It approves more than 99 percent of these requests, and makes meaningful changes approximately 10 percent of the time to improve patient safety.

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Image: Von Unbekannt – Vektordaten: https://www.fda.gov/ucm/groups/fdagov-public/@system/documents/system/fda-square-white.svg, Gemeinfrei, https://commons.wikimedia.org/w/index.php?curid=62130868

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