WHAT WE SAID
"We will save – I do not even want to say thousands, because I think that there are many more, thousands upon thousands ̵1; we will save a tremendous number of lives."
– President Trump who speaks at the signing of the "Right to Trial" legislation on Wednesday
This requires a context.
The legislation that Trump enacted on Wednesday allows terminally ill patients access to experimental medicine that has not been fully approved by the Food and Drug Administration.
Whether "saving hundreds of thousands of lives" is a prediction that is unclear at best. But the effect of similar laws in some states is muted.
Since the 1970s, there has been a program known as "compassionate use" or "extended access". It allows patients with a serious illness or condition to receive experimental medication; The Food and Drug Administration says it authorizes 99 percent of extended access requests it receives.
The new national law, similar to similar laws in more than three dozen states, allows patients and physicians to directly ask drug manufacturers for access to experimental drugs instead of waiting for approval from the agency .
However, these laws "do not ensure that manufacturers will provide the drug or that insurance companies will pay the costs," a policy report from Rice University. Procurement of medicines by manufacturers may be more arduous than going through the existing Food and Drug Administration program.
Colorado implemented the first right-to-try law in 2014. Since then, there have been no documented cases in which anyone had access to an experimental product that would not have been available through the FDA's extended access program, "concluded a study by New York University researchers from 2017.
Alison Bateman House, professor of medical ethics and author of the study, called it "extremely unlikely" that the national law on temptation would save hundreds of thousands of lives directly, given the fact that pharmaceutical companies use them – and get used to – existing ones Process
"It's impossible to say how many people are being helped by federal law to try," said Christina Sandefur, deputy chair of the Goldwater Institute, the conservative group that led the effort.
But "if it rescues a person, it is worth it, "she said, adding," For patients undergoing clinical stud Those who are rejected and unable to manage the complex extended access process will give them the right to one last chance – and the right to hope. "
While the law itself might have a minimal effect, Dr. Bateman-House said the temptation movement and attention that Mr. Trump has focused on taking positive steps to sensitize patients to experimental treatment that the number of patients requesting drug development will increase, especially as part of the current expanded access program.
Sources: Food and Drug Administration, Rice University, Therapeutic Innovation & Regulatory Science, Alison Bateman-House 19659023] Linda Qiu is a Washington-based fact check reporter who joined the Times in 2017 from the fact-checking service PolitiFact. @ ylindaqiu