Statement of Administration Policy: S. 204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

(House Rules)
(Sen. Johnson, R-WI, and 46 cosponsors)

The Administration supports House passage of S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, which will increase access to unapproved, investigational treatments for patients with terminal illnesses. S. 204 would amend the Federal Food, Drug, and Cosmetic Act to create a new, alternative pathway for a broad range of patients diagnosed with life-threatening diseases or conditions.

Far too many patients in our country are faced with terminal illnesses for which there are no treatments approved by the Food and Drug Administration (FDA), or for which they have exhausted all approved treatment options. Biomedical research into treatments for debilitating and deadly diseases, including clinical trials, while proceeding faster than ever, may nonetheless take too long to help patients who are currently sick and may soon die. The Administration believes that these patients and their families should be able to seek access to potentially life-saving therapies while those treatments are still under review by the FDA.

Since the late 1980s, FDA has facilitated access to investigational drugs, devices, and biological products for the treatment of seriously ill patients. Families in these situations have sometimes found this process challenging, and FDA is constantly striving to make improvements to its expanded access program. Some patients and their families, however, still have challenges accessing investigational treatments. The Administration believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physicians. This legislation will advance these principles.

If S. 204 were presented to the President in its current form, his advisors would recommend that he sign the bill into law.