Trump Signs S. 204 “Right to Try Act” For Terminally Ill Patients

by Bamidele Ogunberu Posted on May 30th, 2018

Washington, D.C., USA: U.S. President Donald Trump on Wednesday signed a new bill S.204 “Right to Try Act” which allows terminally ill patients to seek drugs that are still experimental and not fully approved by the U.S. Food and Drug Administration, FDA. After President Trump signed the bill into law he gave the pen to Jordan McLinn, a youngster battling Muscular Dystrophy (our cover photo).

“With the #RightToTry Law I signed today, patients with life threatening illnesses will finally have access to experimental treatments that could improve or even cure their conditions. These are experimental treatments and products that have shown great promise…” Trump wrote after the signing.

Under the legislation, terminally ill patients have the right to seek drug treatments that remain in clinical trials after passing phase 1 of the FDA approval process.

The “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Belllina Right to Try Act of 2017” passed Congress on May 22, 2018 with a 250-169 vote in the House. The Senate earlier passed it in August.

The bill amends Federal law to allow certain unapproved, experimental drugs to be administered to terminally ill patients who have exhausted all approved treatment options and are unable to participate in clinical drug trials.

Eligible drugs must have undergone the Food and Drug Administration’s (FDA) Phase I (safety) testing.

The bill requires any manufacturer or sponsor of an eligible investigational drug to report to the FDA on any use of the drug on a “Right to Try” basis.

The bill limits the liability of drug sponsors, manufacturers, prescribers, or dispensers that provide or decline to provide an eligible investigational drug to an eligible patient.

“The FDA will post an annual summary report of “Right to Try” use on its website”, the White House said..

The bill limits the liability of drug sponsors, manufacturers, prescribers, or dispensers that provide or decline to provide an eligible investigational drug to an eligible patient.

“Right to Try” gives the over 1 million Americans who die from a terminal illness every year a new tool to fight and make potentially lifesaving decisions about their treatment.

According to the National Cancer Institute, an estimated 609,640 Americans will die from cancer alone in 2018.

Prior to this legislation, options for terminally patients who had exhausted all treatment options were extremely limited:
Many terminally ill patients were considered too sick for clinical trials of new medication. In fact, only 3 percent of cancer patients today are enrolled in clinical trials.

The FDA’s “compassionate use” application is complicated and time-consuming, resulting in only about 1,200 approved applications per year.

With President Trump’s signature the Federal government joins with 40 States that have approved the right of terminally ill patients to try potentially lifesaving drugs.

Author

Bamidele Ogunberu

Bamidele Ogunberu

Staff Writer
Phone
Email

Leave a Reply