Trump gave patients a ‘right to try.’ It hasn’t helped them

As Donald Trump seeks a second presidential term, front and center among the achievements he’s touting is the federal Right to Try law he signed in 2018. It was intended to let people who are terminally ill try experimental treatments when there were no approved options and they couldn’t participate in clinical trials. Over the six years of its existence, the law has not lived up to that promise.

During the Republican National Convention, Trump called Right to Try “a big deal.” He claimed it helps terminally ill patients “use our new space-age drugs,” suggested the law is “saving thousands and thousands of lives,” and indicated it was an accomplishment others had failed to achieve for more than half a century.

Trump often invokes Right to Try because the basic idea is popular across the political spectrum. Who wouldn’t want to let people who are dying and desperate try something that might help?

Yet, as researchers who have spent years studying access to investigational medical products, we know that the appealing name belies important shortcomings in the law.

Let’s look at the facts. First, there is no legal “right” to try any investigational medical product. Patients, through their doctors, may ask companies developing such products for access, but there is no requirement for companies to grant it. That’s reasonable, since companies may have lots of good reasons to say no, from inadequate supply of the product to concerns it may not help — or may even hurt — the individual requesting it.

Second, Americans have had the ability to request access to experimental medical products for decades. The Right to Try Act merely repackaged this existing option, called “expanded access,” under a flashier name while stripping out valuable oversight from the Food and Drug Administration that protects vulnerable people facing life-threatening diseases from exploitation and requires prompt reporting of serious harms resulting from a product’s use. By removing FDA oversight, Right to Try offered a solution to a non-problem: the FDA has traditionally quickly approved the vast majority of expanded access requests it receives, and has taken a number of steps to make expanded access easier, from streamlining paperwork to facilitating requests.

Third, Right to Try created a liability shield barring anyone involved in the provision of experimental products under the law from being held accountable for bad outcomes, except under narrow circumstances — even when patients are treated negligently or worse. The idea was to encourage drug companies and doctors to be willing to use this pathway without fear. Yet this was another solution without a problem, as a search of several legal databases failed to identify any reported lawsuits involving use of a drug in an expanded access program.

This does not mean bad things can’t happen when trying an experimental treatment. They can happen, and do. But it does suggest that people understand that experimental treatments come with risk. What is critical, then, is that they receive accurate information about all that is known — and what remains unknown — to make informed decisions about whether to try experimental, potentially risky, products. Prompt reporting of bad outcomes is therefore crucial. Yet Right to Try requires only minimal safety reporting on an annual basis.

Fourth, while the former president falsely claims that Right to Try has saved thousands of lives, required reporting shows the law has been rarely used. The most recent report shows the Act supported access to only 4 products in 2023 and a total of 12 products from 2018 through 2022. Although the number of people treated with those products has not been publicly reported, it’s likely only in the hundreds. For example, in a 2023 press release, Therapeutic Solutions International (TSI) reported providing patients access to a stem cell treatment for brain and lung conditions under Right to Try, while noting the company’s chief medical officer “has treated over 100 patients under the Right to Try Law in collaboration with [TSI] and other Biotechnology Companies” over an unspecified time period.

Patients and companies pursuing Right to Try have little reason to keep it under wraps, so the lack of numerous public examples is telling. Moreover, the number of people treated is far less important than the number helped. Unfortunately, Right to Try does not require companies to report on patient benefit, leaving substantial room for exaggerated claims.

Ultimately, Right to Try is not an improvement on expanded access, which, in fact, continues to be used by thousands of people annually. Yet Republican officials have plans to extend the so-called right to try even further. According to Trump’s spokeswoman, “In his second term, President Trump will of course remain open to other pathways to expand ‘Right to Try’ to save more American lives.” This might include federal efforts to follow state expansions to things like medical marijuana, psychedelics, stem cell products, and “individualized treatments” (described as genetic therapies “tailor-made for one individual”), as well as further efforts to encourage companies to pursue this pathway.

Not coincidentally, the Goldwater Institute — the organization that created the concept of Right to Try in 2014 — is back with what it calls “Right to Try 2.0,” which has already been signed into law in six states: Arizona, Louisiana, Maryland, Mississippi, Nevada, and North Carolina. As before, such legislation is misleading, unnecessary, and will not meaningfully improve access to investigational treatments, individualized or not.

Rather than another empty, feel-good bill, both presidential candidates should commit to improving the options available to dying patients, avoiding false promises, and emphasizing equity. Instead of focusing on mythical red tape in the expanded access pathway, people with serious and life-threatening diseases and conditions would be better served by other efforts, such as:

• Improved access to clinical trials
• Increased awareness of expanded access beyond elite research institutions
• Novel approaches to cover the costs of investigational drugs when there is a good reason to support their use
• Clear expectations for when companies should make investigational products available through the expanded access pathway
• Resolution of important ethical questions about fair access among many patients in need

More broadly, political leaders in the U.S. should set their sights on encouraging the scientific breakthroughs needed to save lives, supporting the FDA in requiring the timely production of clinical evidence that doctors and patients need to inform their treatment decisions but that are too often lacking even for FDA-approved drugs, as well as making sure that both “space-age drugs” and current treatments are accessible and affordable. All of these initiatives would be more challenging than solving non-existent problems and creating feel-good slogans, but these are the accomplishments that would truly be a “big deal” worth touting.

Alison Bateman-House is assistant professor of medical ethics at NYU Grossman School of Medicine. Holly Fernandez Lynch is associate professor of medical ethics and law at the University of Pennsylvania Perelman School of Medicine. Both are uncompensated members of the NYU Grossman School of Medicine’s Working Group on Compassionate Use & Preapproval Access.