The ISSCR is disappointed with the enactment of the ‘Right to Try’ law. Along with more than 100 patient and research groups opposing the bill, we believe it will put patients at risk and undermine the effective FDA Expanded Access Program already in place to give seriously ill patients access to experimental treatments.
“Instead of helping patients, this law will harm patients by providing a route for snake-oil salesman to evade regulation and sell unproven and scientifically dubious therapies to patients,” said ISSCR President Hans Clevers. “In recent months, several patients have been blinded by clinics administering unproven stem cell interventions for eye disease. The Right to Try bill only emboldens bad actors looking for ways to take advantage of desperate patients,” he said.
"Recent comments from Senator Johnson clarified his intent with the legislation--to undermine the FDA's ability to protect patients," Clevers continued. "We support the FDA's mission to protect the health and welfare of patients, ensure the integrity of clinical trials, and provide a clear path for new products to be safely developed and tested. We are hopeful that the FDA continues protecting patients from unscrupulous actors as the agency implements this new law."
The ISSCR supports the FDA’s existing expanded access program, also known as compassionate use, which allows patients to access experimental treatments in a way that provides important checks and balances to ensure patient safety.