Donnelly, Johnson Urge House to Pass Senate-Approved Right to Try Bill

Legislation would allow families like the McLinns of Indianapolis to exhaust all treatment options for a terminally ill family member

WASHINGTON  U.S. Senators Joe Donnelly (D-Ind.) and Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to the House Committee on Energy and Commerce on Monday night in advance of a U.S. House of Representatives Committee hearing today on ‘Right to Try’ legislation. A bipartisan Donnelly-Johnson ‘Right to Try’ bill passed the Senate in August unanimously, and the senators’ letter urged the House to pass the bill immediately.

The senators wrote, in part, in the letter, “This pursuit has always been about protecting hope. Patients (along with their doctors) are informed, capable of making rational decisions, and have the right to do whatever they can to try to save their own lives…Our test has always been a simple one: will the legislation benefit Jordan McLinn, a seven year-old old boy with Duchenne Muscular Dystrophy, a terminal disease by anyone’s standards, but not one that will likely take his life within six months, one year, or even two. 

“…Every day Congress fails to act is a day on which potentially thousands of patients lose hope. As Frank Mongiello, who suffers from amyotrophic lateral sclerosis, stated when the Senate bill was first introduced over 16 months ago, ‘We don’t have the luxury of time.’  On behalf of Frank, Matt, Jordan, and Trickett’s family, we must do whatever we can to ensure that Right to Try is passed by the House and signed into law as soon as possible.”

The letter to the House Energy and Commerce Committee can be found here and below.

October 2, 2017

The Honorable Greg Walden

Chairman

Committee on Energy & Commerce

The Honorable Frank Pallone, Jr.

Ranking Member

Committee on Energy & Commerce

The Honorable Michael C. Burgess, M.D.

Chairman

Subcommittee on Health

The Honorable Gene Green

Ranking Member

Subcommittee on Health

Dear Congressmen Walden, Pallone, Burgess, and Green:

We write to provide additional information to consider as part of the Subcommittee on Health’s hearing on October 3, 2017.   We understand this hearing will include discussion of S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, a bll that passed the Senate unanimously on August 3rd.

As the sponsors of S. 204, named after just a few of the amazing patients who have inspired our work on this issue, you can understand we are passionate about opening potential pathways to treatment for terminal patients when no other alternatives are available. We are proud of this measure’s bipartisan support in the U.S. Senate, including 46 cosponsors.  Over two-thirds of states have already adopted versions of this legislation, with over 97 percent of state legislators voting in favor.

When Chairman Lamar Alexander and Ranking Member Patty Murray of the Senate Committee on Health, Education, Labor & Pensions raised concerns about certain provisions in the bill, we were happy to work with them in a collaborative fashion to successfully address those issues. As such, the bill as passed by the Senate reflects sensible changes, including:

(1) greater transparency surrounding reporting serious adverse events;

(2) a uniform federal definition of eligible patients;

(3) a cap on the price charged for treatments;

(4) further clarification that other provisions governing regulation of drugs still apply

(e.g., good manufacturing practices, labeling requirements, etc.);

(5) provisions maintaining the FDA’s use of adverse outcomes; and

(6) clarifyied liability provisions to protect good actors and exclude bad actors.

These changes were made in addition to the bill’s existing provisions that explicitly maintain incentives for patients to participate in clinical trials and pursue other available treatments, require certification by a doctor that the patient has exhausted available options, and limit eligible treatments to those that have completed a Phase I clinical trial. 

Last Congress, the Senate Committee on Homeland Security and Governmental Affairs, which has jurisdiction over the regulatory process, held two hearings on this issue. We heard testimony from terminally ill patients across the country—such as Matt Bellina of Bucks County, Pennsylvania and Jordan McLinn of Indianapolis, Indiana—for whom the FDA’s status quo is not working. We also heard from a brave doctor in Texas who successfully treated patients under his state’s Right to Try law despite risk of federal sanction. 

We have always been careful not to represent Right to Try as a promise for a cure—Congress cannot legislate a miracle. This pursuit has always been about protecting hope. Patients (along with their doctors) are informed, capable of making rational decisions, and have the right to do whatever they can to try to save their own lives.

Finally, we understand that there may be some discussion regarding who ought to be eligible to participate in Right to Try—whether the definition contained in the legislation is too broad. Our test has always been a simple one: will the legislation benefit Jordan McLinn, a seven year-old old boy with Duchenne Muscular Dystrophy, a terminal disease by anyone’s standards, but not one that will likely take his life within six months, one year, or even two. 

Every day that Congress fails to act is a day during which potentially thousands of patients lose hope. As Frank Mongiello, who suffers from amyotrophic laterals sclerosis, pled when we first introduced the Senate bill over 16 months ago, “We don’t have the luxury of time.”  On behalf of Frank, Matt, Jordan, and Trickett’s family, we must do whatever we can to ensure that Right to Try is passed by the House and signed into law as soon as possible. We are urging the House to take up and pass S. 204 without amendment.

Thank you for working with us on this legislation.

Sincerely,

Joe Donnelly

U.S. Senator

Ron Johnson

Chairman

cc:          The Honorable Joe Barton

                The Honorable Fred Upton

                The Honorable John Shimkus

                The Honorable Tim Murphy

                The Honorable Marsha Blackburn

                The Honorable Steve Scalise

                The Honorable Robert Latta

                The Honorable Cathy McMorris     Rodgers

                The Honorable Gregg Harper

                The Honorable Leonard Lance

                The Honorable Brett Guthrie

                The Honorable Pete Olson

                The Honorable David McKinley

                The Honorable Adam Kinzinger

                The Honorable Morgan Griffith

                The Honorable Gus Bilirakis

                The Honorable Bill Johnson

                The Honorable Billy Long

                The Honorable Larry Bucshon

                The Honorable Bill Flores

                The Honorable Susan Brooks

                The Honorable Markwayne Mullin

                The Honorable Richard Hudson

                The Honorable Chris Collins

                The Honorable Kevin Cramer

                The Honorable Tim Walberg

                The Honorable Mimi Walters

                The Honorable Ryan Costello

                The Honorable Buddy Carter

The Donnelly-Johnson bill that passed the Senate in August can be found here.

Vice-President Pence and the White House also indicated their support of right to try earlier this year.

Thirty-seven states have passed right to try bills on an overwhelming bipartisan basis.

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