US President Donald Trump signed the “Right to Try” Act [text, PDF] into law Wednesday, which authorizes terminally ill patients to seek access to certain unapproved investigational drugs directly from a drug sponsor or manufacturer.
The law amends the Federal Food, Drug, and Cosmetic Act [official website] and also limits the use of clinical outcomes and liability arising from the provision of such drugs and provides reporting requirements for the use and outcomes of the new authority.
The bill requires any manufacturer or sponsor of an eligible investigational drug to report to the Food and Drug Administration (FDA) [official website] on any use of the drug on a “Right to Try” basis. The FDA will post an annual summary report of “Right to Try” use on its website. Under the new law, eligible drugs must have still undergone the FDA’s Phase I (safety) testing.
The law—fully titled the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Belllina Right to Try Act of 2017″—passed the Senate on May 22 and the House in March [JURIST report].
In his remarks at the signing [press release], Trump said, “With the Right to Try law I’m signing today, patients with life-threatening illnesses will finally have access to experimental treatments that could improve or even cure their conditions. … The Right to Try also offers new hope for those who either don’t qualify for clinical trials or who have exhausted all available treatment options.”
In a statement [press release] from the FDA, Commissioner Scott Gottlieb said, “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.”
Critics of the bill argue that it will weaken the ability of the FDA to protect patients.