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.
US President Donald Trump today signed into law a bill that allows 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. Under the new law, signed by Trump at the White House, eligible drugs must have undergone the Food and Drug Administration’s (FDA) 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.
“It is giving terminally-ill patients the right to try experimental, life-saving treatments, and some of these treatments are so promising. 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,” Trump said during the signing ceremony at the White House. “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,” he said.
According to the White House, the Right to Try legislation returns treatment decisions back to patients, giving them the right to make health care 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 per cent 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 Trump’s signature the federal government joins with 40 states that have approved the right of terminally ill patients to try potentially lifesaving drugs, the White House said.