President Signs “Right-to-Try” Legislation

President Donald Trump signed the “right-to-try” bill into law, allowing terminally ill patients to request access to therapies that have undergone phase I testing but have not received U.S. Food and Drug Administration (FDA) approval. This legislation bypasses the need for FDA approval on a patient request for an experimental drug. However, drug-makers can decline the request.  

The “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017” previously passed Congress on May 22. Manufacturers of an eligible investigational drug must report to the FDA any use of a drug on a “right-to-try” basis, and the FDA will publish an annual report of medications used through this legislation. Patients must have exhausted other treatment options and be ineligible for clinical trials. 

“For countless patients, time is not what they have,” the president said. “With the right to try, patients with life-threatening illnesses will finally have access to experimental treatments that could improve or even cure their conditions.” 

Source: USA Today