Giving terminally ill patients a chance, here at home
An estimated 609,640 Americans will die from cancer alone in 2018, according to the National Cancer Institute. Before yesterday, the options for terminally ill patients who had exhausted all available treatments were extremely limited. Only 3 percent of cancer patients today are enrolled in clinical trials for new medication, for instance.
With President Trump’s signature, this bleak picture changes. The “Right to Try” law he signed yesterday gives more than 1 million Americans who die each year from terminal illnesses a new tool to make potentially lifesaving treatment decisions. The act 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.
“People who are terminally ill should not have to go from country to country to seek a cure,” President Trump says. “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.” The White House
🇺🇸 KEEP AMERICA HEALTHY (POSTER: COURTESY OF THE SAGE PAGE & TRUMP-For-America #Maga on FB)
Here is our President:
RIGHT TO TRY: Congress passed the Right to Try Act of 2017, sending a priority bill to President Donald J. Trump for his signature.
The “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Belllina Right to Try Act of 2017” passed Congress on May 22, 2018.
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 FDA will post an annual summary report of “Right to Try” use on its website.
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.
A RIGHT TO LIFE: Right to try legislation returns treatment decisions back to patients, giving them the right to make healthcare choices that could save their lives.
“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.
MAKING HEALTHCARE WORK FOR AMERICANS: Every day, President Trump is working to fix America’s broken healthcare system and return healthcare decisions to individuals.
On May 11, 2018, the President issued his blueprint to lower prescription drug prices, taking action to put American patients first.
President Trump has signed multiple Executive Orders and approved new funding to target the scourge of opioid abuse and is taking the fight to drug abuse across the Nation.
In March 2018, President Trump’s Administration released the President’s plan to put patients back in charge of their own health information.
President Trump is putting healthcare decisions back into the hands of Americans by repealing Obamacare’s individual mandate, ending the healthcare rationing board, and providing more affordable options outside of Obamacare.
THE PRESIDENT: Thank you very much, everybody. I really appreciate it. This is — to me, this is a very important moment, a very important day. Been looking forward to this for a long time, along with Senator Ron Johnson. And I will tell you, we worked hard on this. I never understood why it was hard.
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.
And I want to thank Vice President Pence for helping us so much. Mike was in there, and I’d say, “Mike, how we doing? We got to get it approved.” And he was — he was really working it. And in my State of the Union Address, four months ago, I called on Congress to pass Right to Try. It’s such a great name. Some bills, they don’t have a good name. (Laughter.) Okay? They really don’t. But this is such a great name, from the first day I heard it. It’s so perfect. Right to Try.
And a lot of that trying is going to be successful. I really believe that. I really believe it.
So we did it. And we went through the Senate, we went through the House. The House had a bill. The Senate had a bill. We’d go and mesh them together. We got to go back and take votes. And I said, do me a favor — tell me, which is the better bill for the people? Not for the insurance company, not for the pharmaceutical companies. I don’t care about them. I really don’t. I couldn’t care less. (Applause.)
And that’s the bill I — I won’t tell you which one. But I took the one that was — (laughter) — they said one in particular was great for the people. Not so good for the others, but great for the people. We don’t care about the others right now. And it’s giving terminally ill patients the right to try experimental lifesaving treatments. And some of these treatments are so promising.
And we’re moving that timeline way up anyway, beyond this. We’re moving it way up. But it’s still a process that takes years. Now it takes up to 15 years; even 20 years, some of these treatments are going. But for many years, patients, advocates, and lawmakers have fought for this fundamental freedom. And as I said, incredibly, they couldn’t get it. And there were reasons. A lot of it was business. A lot of it was pharmaceuticals. A lot of it was insurance. A lot of it was liability. I said, so you take care of that stuff. And that’s what we did.
Today I’m proud to keep another promise to the American people as I sign the Right to Try legislation into law. (Applause.)
Right? (Speaks to participant on stage.) You’re so beautiful. So beautiful.
If I looked like that, I would have been President 10 years earlier. (Laughter.) If I had that face, if I had that head of hair, I would have been President so long ago. (Laughter.) That’s great.
So I want to thank a couple of people. Secretary Azar is here. Where’s the Secretary? Secretary? Please stand up. You have worked so hard on this. (Applause.) Thank you very much. You’ve really done a great job. And we’re going to have another exciting news conference over the next, what, three weeks? Four weeks? Two weeks? What do you think? On healthcare. We’re going to have great healthcare. We’ll get rid of the individual mandate. Without that, we couldn’t be doing what we’re doing in a few weeks. We’re going to have great, inexpensive, but really good healthcare.
And we have two plans coming out. We also have, through our great Secretary of Labor, we have a great plan coming out, and that’s through associations. We’re going to have two plans coming out. For the most part, we will have gotten rid of a majority of Obamacare. Gotten tremendous — (applause) — yeah. Could have had it done a little bit easier, but somebody decided not to vote for it, so it’s one of those things.
I want to thank Secretary Azar, and I want to thank Commissioner Gottlieb. Where’s Scott? Scott, stand up. (Applause.) Ooh, I like those — I like those socks, Scott. And, Scott, let me ask you. So it takes years and years to get this approved, right? You’re bringing down — beyond this, you’re bringing down that period of time. What is the average time now it takes for, you know, a major medicine or cure? What’s the average time it takes to go through the system and get an approval?
COMMISSIONER GOTTLIEB: Depends on the medicine. Probably three to seven years.
THE PRESIDENT: Three to seven. And some go long over 10, right?
COMMISSIONER GOTTLIEB: Some can go much longer.
THE PRESIDENT: And you’re bringing that down? You’re trying to bring that down? You know, for safety. Very good. And you, in particular, you’re very happy with this. Aren’t you?
COMMISSIONER GOTTLIEB: We are.
THE PRESIDENT: You have a lot of good things in the wings that, frankly, if you moved them up, a lot of people would have a great shot. Right?
COMMISSIONER GOTTLIEB: We’re trying to get (inaudible), Mr. President, under your leadership.
THE PRESIDENT: Right. That’s fantastic. Well, thank you, Scott. We’re very proud of the job you’re doing.
We’re also working very hard in getting the cost of medicine down. And I think people are going to see, for the first time ever in this country, a major drop in the cost of prescription drugs. Right? (Applause.) And, Mr. Secretary, that’s already happening. Right? That’s already happening. You were telling me yesterday that we’re seeing a big — a tremendous improvement. And you’re going to have some big news. I think we’re going to have some big — some of the big drug companies in two weeks. And they’re going to announce — because of what we did, they’re going to announce voluntary massive drops in prices. So that’s great. That’s going to be a fantastic thing.
You know, we’re working on some really great things. Aren’t we? When you think about it. Ron, pretty good. Huh? We could do some of those — healthcare, drug prices. But this is the baby. Right now.
We would not be here today without the tireless efforts of dedicated members of Congress. That’s so true. I want to especially thank Senator Ron Johnson — stand up please, Ron — (applause) — for his tremendous leadership. You know, I just tell you, he doesn’t stop. He doesn’t give up. You know, it’s good. It’s good for all of us. This guy, Ron, very capable, very — he just doesn’t give up. So when we started working, I knew this was going to happen.
I also want to thank Senator Donnelly. Senator Donnelly, thank you very much. That’s really great. Appreciate it. Thank you. Thank you. (Applause.) A fantastic young gentleman, Brian Fitzpatrick of Pennsylvania. Brian, congratulations. And I know how hard you work, Brian. (Applause.) And Dr. Michael Burgess. Do you like being called “Doctor” or “Congressman”? I think “Doctor” is better. I like “Doctor.” (Laughs.) So we’ll call him Doctor. (Applause.) Thank you, Michael, very much. Great job. You worked — I know how hard everybody worked, and I really appreciate it. Everybody appreciates it. The country appreciates it. Because nobody understood why this wasn’t happening. You know, they’ve been talking about this for how long, Ron? Twenty-five years?
SENATOR JOHNSON: A long time.
THE PRESIDENT: A long time. A lot of talk. Politicians. It’s a lot of talk.
I also want to thank Energy and Commerce Committee Chairman Greg Walden, who’s not here. But he really worked hard with us. He really did. (Applause.) And thanks, as well, to state and local officials here today who fought for this important cause. They fought so hard, so many of them. I want to thank you for the incredible work that you’ve done on behalf of these and all wonderful Americans. I mean, anybody can be there someday. Anybody can be there. Could you all stand up — the state, local people that worked so hard on this? Because you really have been — thank you. Yep. Thank you, fellas. (Applause.) Couldn’t have done it without the state and local, and I appreciate it. Really great job. Thank you.
Most of all, we’re honored to be joined by several brave Americans for whom this bill is named. Matthew Bellina, who is battling ALS, and his incredible wife Caitlin. Matthew. Right? (Applause.) Thank you. Thank you. Laura McLinn and her son, Jordan, who is battling muscular dystrophy. Some good answers. (Applause.) That’s so great. Thanks. Thanks for being with us, Jordan. We’re going to have some good answers for you. (Laughter.) Matthew, you’re going to be happy. You are happy. Frank Mongiello, who’s battling ALS, and who’s joined by his wife, Marylin, and their six children. Wow. That’s fantastic. That’s fantastic. (Applause.) Thank you. Six children. And finally, I want to thank for being here and introduce Tim Wendler, who tragically lost his wife Trickett to ALS, and joined also by their three children. So, Tim, thank you very much. Thank you, Tim. (Applause.)
I want to thank you all for being here. You have extraordinary courage, determination, and love. You have love. Real love. And thanks to you, the countless American lives will ultimately be saved. We will be saving — I don’t even want to say thousands, because I think it’s going to be much more — thousands and thousands, hundreds of thousands. We’re going to be saving tremendous numbers of lives. And it’s so great that you’re up here with us and that we’re all on this front line together.
Each year, thousands of terminally ill patients suffer while waiting for new and experimental drugs to receive final FDA approval. It takes a long time, and the time is coming down. While we were streamlining and doing a lot of streamlining, the current FDA approval process can take, as Scott just said, many years — many, many years. And for countless patients, time, it’s not what they have. They don’t have an abundance of time.
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. These are experimental treatments and products that have shown great promise, and we weren’t able to use them before. Now we can use them. And oftentimes they’re going to be very successful. It’s an incredible thing.
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. There were no options, but now you have hope. You really have hope.
Matthew Bellina, who is here with us, is just one example of many Americans who today has new cause for hope. Due to the late progression of Matt’s ALS, he doesn’t qualify for any clinical trials in the United States. He wouldn’t qualify; couldn’t do it. They tried; he didn’t qualify.
Despite his limited mobility and budget, he was planning on traveling thousands of miles away, to Israel, to receive a treatment that is still awaiting FDA approval in America. No one in Matt’s position should ever have to travel from our great country to another continent or another country to receive a treatment.
Now, with the passage of this bill, Americans will be able to seek cures right here at home, close to their family and their loved ones. We are finally giving these wonderful Americans the right to try. So important. (Applause.)
America has always been a nation of fighters who never give up. Right? We never give up, ever. Right? Never give up. We’re fighters, like the amazing patients and families here today.
Now, as I proudly sign — and this is very personal for me. But as I proudly sign this bill, thousands of terminally ill Americans will finally have the help, the hope, and the fighting chance — and I think it’s going to be better than chance — that they will be cured, that they will be helped, that they’ll be able to be with their families for a long time or maybe just for a longer time. But we’re able to give them the absolute best, as to what we have at this current moment, at this current second. And now, we’re going to help a lot of people. We’re going to help a lot of people.
So it’s an honor to be signing this. And if I might, I think I’ll present — I think I have to do this, Ron. I have to present this good-looking guy with the first pen. Is that okay? You don’t mind, right? Okay, good. I’m going to do that. (Applause.)
(The bill is signed.) (Applause.)
So I want to thank — (laughter) — it’s going to be fantastic.
Thank you all very much. This, to me, is very exciting. And you’re going to see some tremendous results. We’re going to have some incredible, incredible results.
So thank you all for being here. And all of the people in the audience who have been so helpful, thank you very much. It’s going to be something very, very special. Thank you. (Applause.)