No Evidence for Trump’s Right to Try Claim
As he has done for years, President Donald Trump claims – without evidence – that the federal Right to Try law he signed in 2018 has “saved thousands of lives.” But the White House provided no support for Trump’s claim about the law, which provides an alternative route for seriously ill patients to access unapproved drugs outside of clinical trials.
Researchers who have long studied access to investigational drugs say the president is greatly exaggerating.
“It’s not that nobody is using Right to Try. 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, told us 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, said in an interview that Trump’s claim about the law saving thousands of lives is a “gross misestimate.”
Dr. Jeffrey A. Singer, a senior fellow at the libertarian Cato Institute who said he supported passage of the 2018 federal law, now says that it “fail[ed].” In a May opinion piece for Reason magazine, Singer argues for changes to the Right to Try law, writing that the promise of a right to try potential life-saving drugs “often exists more on paper than in practice.”
Reason, May 12: The sales pitch was sweeping. When President Donald Trump signed Right to Try in 2018, surrounded by patients, he promised a “fundamental freedom” that would give dying patients hope.
Eight years later, the record is far thinner than the rhetoric. The [Food and Drug Administration] reports only a handful of uses each year—12 drugs from 2018 to 2022, and just a few more annually since. It wasn’t a new pathway so much as a permission slip that rarely translates into access.
The FDA is required to publicly report the number of investigational drugs used under the Right to Try 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 our request for the number of patients treated under the federal law.
We asked the White House for the number of patients treated under the Right to Try law and evidence that thousands of lives were saved. But it provided no support for Trump’s claim — which he repeated throughout the 2024 presidential campaign, including in his acceptance speech at the 2024 Republican convention. Most recently, the president said in April that Right to Try has “saved thousands and thousands of lives,” and he said it again in May, when he claimed the law has “saved thousands of lives,” but “nobody talks about it.”
“President Trump is right: Right to Try was a historic victory from his first term, which has allowed many Americans to access treatments that would have otherwise been blocked by the regulatory approval process,” White House spokesperson Kush Desai said in an email.
The Goldwater Institute, which takes credit for helping to enact 41 state Right to Try laws prior to passage of the federal law, provides some examples on its website of patients using Right to Try laws on the state and federal level. But the institute – which claims the “Right to Try law has a proven track record” – doesn’t know how many patients have received investigational drugs through the federal law.
“[U]nfortunately the Goldwater Institute is not able to track utilization of Right to Try given patient privacy laws,” Goldwater Institute spokesperson Ryan Mills told us in an email.
Right to Try and the FDAThe federal Right to Try law was controversial from inception because it removes the FDA from the oversight and approval process for the use of unapproved drugs outside of clinical trials. Under Right to Try, unapproved drugs can be used without FDA approval to treat patients diagnosed with a “terminal illness,” which is defined as a “life-threatening disease or condition,” who have exhausted approved options and are unable to participate in a clinical trial.
Critics say Right to Try is unnecessary – and potentially dangerous – because the FDA has long had an expanded access program that allows patients to use unapproved drugs outside of clinical trials.
In 2016, when a Senate committee was considering Right to Try legislation, then-FDA official Peter Lurie credited the expanded access program for making unapproved drugs available quickly to thousands of seriously ill patients, while protecting “desperate patients” from “unnecessary risks” and exploitation by “unscrupulous individuals.”
“FDA has authorized more than 99 percent (7110/7176) of single patient expanded access Investigational New Drug (IND) requests received in Fiscal Years 2010-2015. Emergency requests are usually granted immediately over the phone and non-emergencies are processed in a median of four days,” Lurie, who was associate FDA commissioner for Public Health Strategy and Analysis, said in written testimony.
Since then, the number of requests has increased and approval rates have remained largely unchanged.
For fiscal years 2019 through 2023, the FDA approved 99% (17,806/17,964) of single-patient expanded access IND requests, the most recent FDA data show. Several experts on FDA law and policy told us that these figures suggest that Right to Try hasn’t had much of an impact.
“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%,” Patricia Zettler, a law professor at Ohio State University who teaches public health and FDA law courses, told us in an interview. “Given that, there’s … no logical reason to think Right to Try would change the landscape dramatically.” (Zettler served as deputy general counsel at the Department of Health and Human Services, covering the FDA, during the Biden administration.)
Under both pathways – Right to Try and the expanded access program – companies developing new drugs are not required to make them available to patients. As a result, pharmaceutical companies — not the FDA — remain “the larger obstacle” to giving patients access to unapproved drugs, Lurie told us in an interview.
“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 told us that “large biopharmaceutical companies are not using Right to Try … 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.”
One incentive for biopharmaceutical companies to seek FDA oversight, she said, is that the agency can draw upon confidential proprietary information it has from clinical trials and other expanded access treatments to require companies to change proposed treatment plans prior to approving expanded access requests. That protects patient safety and benefits the development of the investigational drug, Bateman-House said.
Pfizer and Johnson & Johnson, for example, have said that they support FDA oversight when providing investigational drugs outside of clinical trials.
In 2015, Johnson & Johnson created a bioethics panel headed by Arthur Caplan, co-chair of NYU Grossman School of Medicine’s Working Group on Compassionate Use & Preapproval Access, to develop a policy on the use of investigational drugs. In its policy statement, Johnson & Johnson said FDA oversight is required “to assure full consideration of available safety data of which the FDA may be uniquely aware.”
In an article last year for the American Health Law Association, Barbara Bierer, a professor at Harvard Medical School, and her co-authors wrote that physicians are also reluctant to use Right to Try, in part because of “the abrogation of regulatory and ethical oversight.”
The article, which said “data on the prevalence of RTT are scant,” cited a survey of community oncologists that found 46% of 238 respondents attempted to use the expanded access program, while only 14% of the respondents attempted to use Right to Try. The paper also cited the American Society of Clinical Oncology’s opposition to Right to Try.
American Health Law Association, Jan. 24, 2025: Current data on the prevalence of RTT are scant, but the data that are available suggest that oncologists are considerably more likely to request access to an unapproved drug via EAP than they are via RTT. Given that the major difference between EAP and RTT is FDA oversight, a threshold question is whether FDA acts to deter or delay the approval of EAP requests. Evidence suggests that as many as 99% of all EAP requests are approved by FDA often within the first few days.
Despite its social media presence and visibility, demand for access via RTT has yet to materialize. Some experts have explicitly advised physicians to “steer patients away from RTT and toward [EAP]” while others claim they would never encourage a patient to avail themselves of RTT. The American Society of Clinical Oncology (ASCO) released a public statement condemning RTT, stating “ASCO supports access to investigational drugs outside of clinical trials when adequate patient protections are in place . . . We don’t support right to try legislation, however, because these laws ignore key patient protections without actually improving patient access to investigational drugs outside of clinical trials.”
One thing that critics and supporters of the Right to Try can agree on is that the push for such laws on the state and federal level 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 told us. “Maybe some number of people were able to experience a positive health benefit via that. But it wasn’t because of Right to Try. It was because they were asking for something that they had had access to all along. They just didn’t realize they had access.”
Singer, the Cato senior fellow, independently raised the same point in a separate interview with us.
Singer — who was a visiting fellow at the Goldwater Institute from 2017 to 2026 — told us that he still supports the “concept” of Right to Try, even though he believes “there haven’t been many instances of Right to Try” being used to make unapproved drugs available to seriously ill patients.
He added that he did not want to minimize the indirect benefits of the law. Singer said Right to Try had “an impact on the FDA” by raising public awareness of the expanded access program and forcing the agency to simplify its expanded access application process.
Singer sent us a link to the same survey of oncologists cited by the American Health Law Association. That paper said “awareness of the EA program was high among the community oncologists we surveyed.” It also said the “revised, simplified” expanded access application now takes only 45 minutes to fill out.
As we mentioned, there has been an increase in expanded access requests and approvals, so there is data to support the theory that the Right to Try law has had an indirect benefit. But there is no evidence to support the president’s claim that the law has “saved thousands of lives.”
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