The “Right to Try” is About Time for Those Fighting for Their Lives

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If you are fighting for your life with a terminal illness, there are few things more powerful than hope.  The United States produces the vast majority of new drugs and technologies in healthcare, yet we have among the most restrictive policies when it comes to allowing innovative treatments for those who are terminally ill.  One of President Trump’s most consistent campaign promises was that he was going to address that serious problem.  He has begun fulfilling that promise with his signing of the “Right to Try” Act.

For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access products through clinical trials. This is the mission of our expanded access program. The agency is dedicated to these purposes, and it has been for more than three decades.

Food and Drug Administration Commissioner Scott Gottlieb said in a statement that:

“We’ve taken many steps to improve our process through which patients can access promising investigational drugs. We understand that treatment decisions for those facing terminal illnesses are best made by patients and families, with the support of their treating physicians. When appropriate, those suffering from a terminal illness who’ve exhausted available options should be able to access promising treatments being studied in clinical trials, or products under active review by the FDA. The agency is faithfully committed to these goals, to protecting patients, and to making sure they’re able to make informed decisions.

“Today, the President signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act). At the FDA, we stand ready to implement this legislation in a way that achieves Congress’ intent to promote access and protect patients. The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines.

“This new law amends the Federal Food, Drug, and Cosmetic Act to establish a new pathway aimed at increasing access to unapproved, investigational treatments for patients diagnosed with life-threatening diseases or conditions who have exhausted approved treatment options and who are unable to participate in a clinical trial. Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths.

“The decisions we reach related to products that can serve as an effective treatment for a terminal illness, or that can arrest a devastating and debilitating condition, are among the most important and carefully considered judgments that we make. We recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances. And we’ll implement this new law consistent with these longstanding values.

“The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

President Trump talked about the challenges of getting this bill passed, stating: “They’ve been trying to have it passed for years.  I never understood why.  Because I’d see people — friends of mine, and other people I’d read about, where they’d travel all over the world looking for a cure.  And we have the best medical people in the world, but we have trials and we long time — 12 years, 15 years.  Even when things look really promising, so many years.  And I never understood why they didn’t do this.  And we worked very hard.”

The President’s Press Secretary office released a statement, stating: “This Administration believes that treatment decisions for those facing life-threatening illnesses are best made by the patients with the support and guidance of their treating physicians. This legislation advances these principles. Almost forty states have passed their own versions of this important legislation, and we look forward to addressing this at the Federal level. Implementing patient-centered healthcare policies is a priority of this Administration, and we will continue our work to ensure Americans have access to the healthcare options they deserve.”

 

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