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Senator Johnson – WI Introducing the Right To Try Bill in the Senate on May 10, 2016

Use these talking points as you spread the word about this bill.

The Right to Try is the opposite of the Right to Die. It’s about the right to try to save your life. Every year a million Americans with terminal diagnoses will hear from their doctor that there are no options left, and it’s time to get their affairs in order. What they really mean is that in their toolbox of approved medicines, there’s nothing left. But the truth is there are more than 500 treatments just for cancer stuck in the FDA’s pipeline right now; many already available in Europe. The Right to Try gives patients access to those medicines.

The Right to Try is a law to help people like a young woman named Mikaela. Mikaela had just gotten married when she was diagnosed with kidney cancer. Less than five months after she died, the FDA approved the drug she had been seeking. Right To Try would have given her another option for requesting the drug.

It’s a basic human right to be able to fight for your life and the laws of the land should reflect that. Patients shouldn’t have to beg the federal government for permission to try to save their own lives. If you know there’s a treatment that is helping people survive, who is anyone to say, “No, you don’t have the right to try to save your life.” “No, you don’t have the right to try to save your child.” Americans support the Right to Try.

• Two years ago, a man named David Huntley was diagnosed with Lou Gehrig’s disease. He was an ironman athlete, a professor and a father, and he wasn’t about to go down without a fight. In early 2015 he testified before the California legislature on Right To Try and said, “Without any treatment, I will pass in 6-9 months. How is keeping me from investigational treatments saving my life? At the very least, it gives me something to fight back against this horrendous disease.” Dr. Huntley never got access to the treatment he sought and he passed on a few months later.

The federal government should green light this policy immediately. It’s been 25 years since Washington has moved any kind of major reform to help patients. We don’t have time to wait.

• We’re not talking about pimple cream for healthy teens. This is about people with Lou Gehrig’s disease, brain cancer, and lung cancer. If you were on a sinking ship, would you pass on the only available lifeboat because the government hadn’t certified it yet? No, you’d say, put the lifeboat in the water. Right To Try gets the lifeboats in the water.

The risks for someone who takes a drug under Right To Try are exactly the same as they are for patients who get into government-sanctioned clinical trials. These are the same medicines the FDA is allowing a lucky few to take in clinical trials.

We’ve all known someone who has suffered from a terminal illness. This law is common sense. When you are fighting for your life, you shouldn’t have to fight the government too.

Millions of Americans are dying this year from terminal illnesses for which there are treatments and cures. About 40,000 women with breast cancer will hear from their doctor this year that there are no treatment options left. But there are 22 pioneering breast cancer treatments waiting for the FDA’s green light; some of them are already available in Europe.

About 40,000 Americans die each year of a fatal lung disease called IPF. There were no effective treatments until a company named InterMune developed a breakthrough therapy called Esbriet. Esbriet was on the market in Japan 7 years before it was available here, 4 years earlier in Europe, 2 years earlier in Canada. Hundreds of thousands of Americans died while the FDA blocked access to the only known treatment for this disease.

You don’t walk around with a 15-year-old phone in your pocket because it doesn’t work. And you shouldn’t have to walk around with 15-year-old medicines that don’t work. In drug development, it takes about 15 years from discovery to market. The FDA is helping people 15 years from now, not today. Right To Try gets people treatments today, before it’s too late.

80 percent of oncologists say the FDA’s lengthy process has hurt their ability to treat their patients with the best possible care.

In California, if you have a terminal diagnosis, you can get drugs to end your life but you can’t get drugs to save your life.

Let’s talk about the Meningitis outbreak on college campuses in 2013-2014 that took the lives of students at Georgetown, Princeton and elsewhere. After the first case appeared, it took 9 months for the FDA to get the vaccine to Princeton, and it never made it to the other universities. The vaccine had already been approved in Europe, Canada and Australia. As one of the victim’s mother said, “If those decision makers at the FDA had to watch their sweet daughter die such a death, I have a feeling the decision would be made a little quicker.”

Right To Try may seem new to the U.S., but it’s basically been law in Europe for 25 years. If a doctor thinks an investigational treatment will help, she can prescribe it. The treatments are paid for largely through state and private insurance. This type of program has been tested for decades in Europe and it works.

• In addition to passing Right To Try, we are working at the federal level to have our government adopt a policy of drug approval reciprocity. If a drug is available in Canada or the EU, it should be available here.

FDA should make compassionate use the rule, not the exception, through a provisional access program. This would let companies put drugs on the market earlier with a rigorous system of “post market surveillance.” Patients would get access to medicines earlier; companies can be compensated; and insurance can cover the cost. The Obama administration and previous Republican administrations have all proposed this—it’s a bipartisan issue.