Right to Try Law: Limited Use, No Evidence for 'Thousands of Lives Saved' Claim
核心洞察
President Trump's claim that the federal Right to Try (搜索) law has "saved thousands of lives" is unsupported by evidence, with the FDA reporting only 21 investigational drugs used under the law from 2018 through 2024.
Experts including Holly Fernandez Lynch and Alison Bateman-House characterize the claim as a "gross misestimate," noting only a "handful of reported cases" of Right to Try (搜索) utilization.
The FDA's expanded access program approved 99% of single-patient requests (17,806 of 17,964) from fiscal years 2019-2023, suggesting Right to Try (搜索) has had minimal impact on patient access.
President Donald Trump has repeatedly claimed that the federal Right to Try (搜索) law he signed in 2018 has "saved thousands of lives." However, researchers who study access to investigational drugs say the president is greatly exaggerating, and the White House has provided no evidence to support the assertion.
"It's not that nobody is using Right to Try (搜索). There have been a handful of reported cases," Holly Fernandez Lynch, associate professor of medical ethics at the University of Pennsylvania Perelman School of Medicine, said in an interview. "But certainly it has not been thousands of patients … who've received drug therapy, let alone had their lives saved by these products."
Alison Bateman-House, co-chair of NYU Grossman School of Medicine's Working Group on Compassionate Use & Preapproval Access, called Trump's claim a "gross misestimate."
What the Data Show
The FDA is required to publicly report the number of investigational drugs used under the Right to Try (搜索) law — but not how many patients have been treated. FDA annual summaries show that 21 investigational drugs have been used from May 30, 2018, through Dec. 31, 2024. The FDA did not respond to requests for the number of patients treated under the federal law.
Dr. Jeffrey A. Singer, a senior fellow at the libertarian Cato Institute who supported passage of the 2018 federal law, now says that it "fail[ed]." In a May opinion piece for Reason magazine, Singer wrote that the promise of a right to try (搜索) potential life-saving drugs "often exists more on paper than in practice."
The FDA's Expanded Access Program: A Proven Alternative
Critics argue Right to Try (搜索) is unnecessary because the FDA has long maintained an expanded access program that allows patients to use unapproved drugs outside of clinical trials. For fiscal years 2019 through 2023, the FDA approved 99% (17,806 of 17,964) of single-patient expanded access Investigational New Drug (IND) requests, according to the most recent FDA data.
"If you look at the information FDA publishes about expanded access requests, you see that FDA authorizes the overwhelming majority of them. You know, many years, 99%," said Patricia Zettler, a law professor at Ohio State University who teaches public health and FDA law courses. "Given that, there's … no logical reason to think Right to Try (搜索) would change the landscape dramatically."
The Real Barrier: Pharmaceutical Companies
Under both pathways — Right to Try (搜索) and the expanded access program — companies developing new drugs are not required to make them available to patients. Former FDA official Peter Lurie noted that pharmaceutical companies, not the FDA, remain "the larger obstacle" to giving patients access to unapproved drugs.
"Companies are more likely to say no than the FDA, by far," Lurie said. "The claim that FDA is the obstacle is not true."
Bateman-House added that "large biopharmaceutical companies are not using Right to Try (搜索) … because if you're trying to bring a product to market through the FDA, you don't really have any incentive to avoid the FDA when you're handing out your unapproved product."
Physician Reluctance and Ethical Concerns
An article published last year for the American Health Law Association, co-authored by Harvard Medical School professor Barbara Bierer, noted that physicians are reluctant to use Right to Try (搜索), in part because of "the abrogation of regulatory and ethical oversight." The article cited a survey of community oncologists that found 46% of 238 respondents attempted to use the expanded access program, while only 14% attempted to use Right to Try.
The American Society of Clinical Oncology (ASCO) released a public statement opposing Right to Try (搜索), stating that these laws "ignore key patient protections without actually improving patient access to investigational drugs outside of clinical trials."
An Indirect Benefit: Raising Awareness
One point of agreement between critics and supporters is that the push for Right to Try (搜索) laws has raised awareness of the FDA's expanded access program. "The most charitable thing I can say is, I think the Right to Try law probably increased awareness of the idea that it is possible to use unapproved drugs outside of clinical trials," Bateman-House said.
Singer echoed this view, noting that Right to Try (搜索) had "an impact on the FDA" by raising public awareness of the expanded access program and forcing the agency to simplify its application process. The revised, simplified expanded access application now takes approximately 45 minutes to complete.
Despite this indirect benefit, there remains no evidence to support the president's claim that the Right to Try (搜索) law has saved thousands of lives.