publication date: Jun. 1, 2018

Rejoice or despair: Right to Try becomes law

By Matthew Bin Han Ong and Paul Goldberg

President Donald Trump May 30 signed the “Right to Try” bill into law, making it possible for terminally ill patients to bypass FDA to gain access to experimental drugs.

The legislation removes FDA’s mandate to determine whether individual patients can receive investigational drugs. The agency’s expanded access program remains intact as an option for patients and physicians who desire expert FDA review.

The long path toward passage of this law began in 2013, and during those five years pretty much everything that could be said has been said, and said again (The Cancer Letter, March 23).

Supporters said that the new law will speed lifesaving treatments to dying patients by removing bureaucratic FDA red tape (The Cancer Letter, March 23).

Meanwhile, critics said the measure will not improve access, but instead will legitimize medical quackery and erode patient protections that come with FDA’s expanded access program (The Cancer Letter, March 23, 2018; Aug. 4, 2017; April 14, 2017).

Trump, a vocal proponent of the measure, said he liked its name:

“Right to Try. That’s such a great name. Some bills, they don’t have a good name. Really. But this is such a great name, from the first day I heard it. Right to Try. And a lot of the trying is going to be successful. I really believe that. I really believe it.”

FDA Commissioner Scott Gottlieb said the agency would implement the new law.

“Our implementation of the Right to Try Act will build … Continue reading Rejoice or despair: Right to Try becomes law

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