The defeat yesterday in the House of a “right-to-try” bill was a victory for patients across the country. Although proponents of the proposed legislation claimed that it would give terminally ill patients access to experimental medications more easily, the fact is the program would have been potentially risky for patients and protected pharmaceutical companies at the expense of patients’ health.
Those of you who are regular MedShadow visitors are likely familiar with the legislation itself. We’ve covered it quite a bit, and I wrote in this column last month about the dangers of the bill. If you aren’t familiar with “right-to-try” legislation, that blog post is a good primer.
The vote on the bill was 259-140, in favor. However, because of a change in the rules for this vote, a 2/3 majority was needed for passage. The defeat is a major blow for Republicans, many of whom had highly touted the legislation. President Trump even mentioned the bill in his January State of the Union address.
In a statement, Rep. Frank Pallone (D-NJ) explained why the bill’s defeat was a victory, saying the vote “protected patients and supported the FDA’s continued role in approving experimental treatments that may help save a patient’s life.”
The “right-to-try” movement isn’t being driven by concern for patients at all, but rather to protect drug companies.
The vote may also have been influenced by a letter –- signed by close to 80 patient groups — sent Monday to Speaker of the House Paul Ryan (R-WI) and Minority Leader Nancy Pelosi (D-CA). In it, the groups argued that the legislation would have watered down protections for patients.
“FDA is also prohibited from halting access to these experimental therapies short of placing a clinical hold on all clinical research on the therapy in question, which is a blunt and disproportionate measure,” the letter reads. “The legislation would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program.”
The good news is that patients that want access to experimental medications already have it, thanks to the FDA’s compassionate use program. About 99% of requests for such drugs are approved by the FDA.
So, if there’s a program in place similar to “right-to-try” and most requests are granted, why the need for national legislation at all? Good question. The “right-to-try” movement isn’t being driven by concern for patients at all, but rather to protect drug companies. The legislation would shield Big Pharma from legal liability and increased scrutiny from the FDA if a patient was harmed or even died after taking an experimental medication.
The Senate approved its version of a “right-to-try” bill last year. With yesterday’s action, however, the future of such legislation becoming law is uncertain at best. Let’s hope yesterday’s vote marks the end of national “right-to-try” legislation.