Trump signs bill for terminal patients to try unproven drugs
The US president had supported efforts to gain access to the treatments during his 2016 campaign, with the bill clearing the House last week.
President Donald Trump has signed legislation aimed at helping people with deadly diseases try experimental treatments, calling it a “fundamental freedom” that will offer hope and save lives.
Mr Trump signed the so-called Right to Try bill and said he never understood why the issue had lagged for years and Congress had not acted sooner.
He was joined by families dealing with diseases including amyotrophic lateral sclerosis – also called Lou Gehrig’s disease.
“There were no options. But now you have hope — you really have hope,” he said, noting that “for many years, patients, advocates and lawmakers have fought for this fundamental freedom.”
The bill cleared the House last week following an emotional debate in which Republicans said it would help thousands of people in search of hope. Many Democrats said the measure was dangerous and would give patients false hope.
As he distributed pens after signing the bill at a small table, eight-year-old Jordan McLinn of Indianapolis, who suffers from muscular dystrophy, waited to embrace the president, drawing laughter in the auditorium when he put his elbow on the table and held up his chin.
Mr Trump hugged the boy and kissed him on the forehead, telling his mother: “He’s going to be fantastic.”
The president was joined by Health and Human Services Secretary Alex Azar, Food and Drug Administration Commissioner Scott Gottlieb and some of the bill’s allies in Congress, including Senators Ron Johnson, and Joe Donnelly.
Mr Trump had supported efforts to gain access to the treatments during his 2016 campaign.
In his State of the Union address, the president said people who are terminally should not have to travel “from country to country to seek a cure”.
The measure would give people diagnosed with life-threatening conditions who have exhausted treatment options the ability to gain access to unproven drugs without first getting permission from the FDA.
New drugs normally undergo years of expensive testing before manufacturers seek and gain FDA approval to market them.
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... pic.twitter.com/FIUwhpUpoL— Donald J. Trump (@realDonaldTrump) May 30, 2018
Opponents of the bill said it would empower “fly-by-night physicians” to offer false hope and ineffective drugs to patients who are desperate for treatment.
They also said the bill created the incorrect impression the FDA serves as a bottleneck that deprives dying patients of unproven options.
FDA figures show it approves 99% of the roughly 1,000 requests it receives from doctors annually for so-called “compassionate use” of such treatments.
The process generally takes about four days, but permission can be granted immediately by phone in emergencies.
The bill was supported by the libertarian Goldwater Institute and the conservative Americans for Prosperity, which is backed by the wealthy brothers Charles and David Koch.
It also offers some legal protections for pharmaceutical companies, doctors or others involved in providing the treatment.