President Trump on Wednesday signed into law a bill that would allow those with potentially terminal diseases to try experimental treatments and bypass the U.S. Food and Drug Administration.
The so-called Right to Try Act of 2017, sponsored by Sen. Ron Johnson, R-Wis., unanimously passed the Senate last August, and cleared the House last week on a party-line vote of 250-169 — in a win for both Johnson and the Trump administration.
“Today I am proud to keep another promise to the American people as I sign the Right to Try legislation into law,” Trump said Wednesday. “We’re going to be saving tremendous numbers of lives.”
The president said the issue was “very personal” for him.
“As I proudly sign this bill, thousands of terminally ill Americans will 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 will be able to be with their families for a long time, or maybe just for a longer time,” Trump said. “But we’re able to give them the absolute best we have at this current moment, at this current second. We’re going to help a lot of people. It’s an honor to be signing this.” full story
It’s nice to see a President stand up to the FDA!
Thank Republicans for your Right to Try
Imagine the horror of learning you have a terminal illness for which science has not yet come up with a treatment. Now imagine receiving the same diagnosis, and then learning a promising new treatment exists that could save your life — but you can’t get access to it thanks to governmental obstacles.
That is the nightmare that befell Andrea Sloan, an Austin lobbyist who gave up her job at a high-priced law firm to advocate for victims of domestic violence.
In 2007, Sloan was diagnosed with ovarian cancer, and for more than six years tried every Food and Drug Administration-approved treatment for her disease. All failed. With Sloan’s health rapidly deteriorating, her doctor at MD Anderson Cancer Center told her she had one last hope: a new drug that inhibits DNA repair in cancer cells, which had shown great promise in clinical trials with patients that had her specific genetic mutation.
But Sloan did not qualify for a clinical trial. And while the drug had passed safety trials, it was not yet approved by the FDA. She would have to seek “compassionate use.” After months of lobbying (and being turned down by one manufacturer), she finally convinced another to grant her access. She was ready to begin treatment, but then she hit a deadly roadblock: Before she could obtain the drug her physician recommended and that a manufacturer was willing to provide, she had to beg the FDA for approval. Her doctor was forced to spend around 100 hours filling out FDA paperwork (a requirement that has since been streamlined , thanks to public pressure). Then, the FDA took 24 days to review the application.
As Sloan waited, her health deteriorated further. In an interview for the book “The Right to Try : How the Federal Government Prevents Americans From Getting the Lifesaving Treatments They Need ,” which I co-wrote, Sloan’s best friend Michelle Wittenberg told me about Sloan’s anguish as she waited on the green light from Washington. “She would say, ‘Michelle, what’s going on? What’s the delay? The drug company’s agreed to give it, why is it taking so long?’ ” When the FDA finally relented, the drug worked. Scans showed it beating back her cancer. But it was too late. Shortly after getting the scans, Sloan came down with pneumonia. Thirteen days later, she died. “The delay in getting that drug that was working killed her,” Wittenberg said, “The extra month tacked on because of the FDA process? Too long.”
Wittenberg formed “Andi’s Army” to lobby the Texas state legislature to pass a “Right to Try” law which would grant those in Texas with terminal illnesses (and who have exhausted all FDA-approved treatments) access to investigational drugs — so long as they have been proven safe in clinical trials, are part of the FDA’s ongoing evaluation process, and the company developing the medication is willing to make it available. In 2015, Gov. Greg Abbott (R) signed the “Andrea Sloan Right to Try Act” into law. full story