After a year in which President Donald Trump devoted much of his health policy attention to efforts to repeal and replace the Affordable Care Act, Mr. Trump used part of his recent State of the Union address to press Congress to focus attention in 2018 on a new health priority – the passage of "right to try" legislation.

Right to try legislation gives terminally ill patients the right to use experimental medications that have not yet been approved by the Food and Drug Administration. In 2017, the U.S. Senate unanimously passed HR 878, legislation that would do just that and the president's address has pressured the U.S. House to follow suit, where a bill is now being debated in committee.

President Trump's push for the passage of right to try nationally builds on the efforts of the Libertarian-leaning Goldwater Institute, which has used the broad popularity of the policy to help achieve passage of similar legislation in 38 states, even though it diverges with current federal regulations.

Despite these state gains and the policy's growing popularity among states, ethical questions remain about the tangible impact of a federal right to try law on Americans with terminal illnesses. Most notably, a growing body of evidence from policy analysts argues that the legislation would unfortunately accomplish very little change for most patients, and it could actually make it harder to get new drugs approved in the future.

How the drug approval process works

Pharmaceuticals in the United States are regulated by the FDA. When a drug company develops a new compound intended for patient use, the medication goes through three phases of clinical trials that often take years to complete.

The first phase of trials requires a company to prove the drug is relatively safe for humans – that the drug itself will not poison the patient. These phase 1 trials are often conducted on as few as 30 patients.

In later phases, the clinical trials test whether the drug is effective at treating the condition for which it is intended without problematic side effects. It is at this stage that the vast majority of drugs fail to pass approval, because many drugs turn out to be ineffective or to cause severe side effects.

The right to try legislation the Trump administration is currently pushing would authorize doctors to administer drugs that have cleared the first phase, but which have not yet completed these later human clinical trials. By doing so, the legislation gives terminally ill patients the right to use potentially lifesaving medications without rigorous testing from the FDA and without years of waiting for the drugs to become commercially available.

For people suffering from terminal conditions such as amyotrophic lateral sclerosis, or ALS, for which there are promising treatments in the midst of the approval process, the legislation brings hope.

That said, we believe the promises made by right to try advocates are far greater than the actual impact it will have on patients.

"Right to try" grants no real rights

Despite good intentions – and the legislation's name – right to try legislation grants no rights. It would merely grant permission for a patient to try to get experimental medication from a pharmaceutical company.

Patients would be allowed to try experimental drugs, but nothing in the legislation would make it mandatory for pharmaceutical companies to provide these medications.

The reasons for a company to withhold a drug are many. Giving access to preapproval drugs can be costly, particularly given the limited supply, and almost no medical insurance will cover experimental treatments. Access to the drugs will likely only be feasible for wealthy Americans who can afford to pay for the treatment, as well as the consequences of any negative side effects out of pocket.

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