Two months after a setback in the U.S. House of Representatives, Congress has authorized “right to try” legislation.
Two months after a setback in the U.S. House of Representatives, Congress has authorized “right to try” legislation that provides a pathway for terminally ill patients to seek access to experimental drugs that could save their lives.
On Tuesday the House overwhelmingly voted in favor of the bill, 250-169, CNN reported. The U.S. Senate unanimously passed the legislation last August. The bill is now on its way to the desk of President Donald Trump, who has offered strong support for it during his State of the Union Address in January. Trump is expected to sign the legislation.
The legislation will allow those terminally ill patients to appeal for access to those medications that could save their lives, as long as they have cleared Phase I of clinical testing. Supporters of the legislation say the bill provides a lifeline for those patients, while critics argue the legislation will weaken regulatory protections and also fail to address fundamental obstacles to experimental drugs. Some patient organizations have also expressed concern over the bill because they argue it removed the U.S. Food and Drug Administration (FDA) from the process.
Despite the expected approval of the legislation, pharmaceutical companies that are developing the experimental medications will still have to sign off on whether or not a patient gains access. The companies are not obligated to provide those drugs to patients, not in their control groups.
Currently, the majority of states, about 40, have already passed right-to-try laws, which prompted the federal movement. Proponents of the legislation say the federal law will save patients time when they are applying for use of these experimental medications.
FDA Commissioner Scott Gottlieb said on Twitter that he is comfortable with the legislation and is “ready to work to implement” the measure in order to “promote access to promising therapies for terminal patients and protect their interests.” Last year Gottlieb noted that the right-to-try legislation was unlikely to provide any additional options that the FDA’s compassionate use program already does. The FDA says its compassionate use program is “a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Such investigational drugs have not yet been approved by the FDA, and they have not been proven to be safe and effective.”
BioSpace reported earlier that the FDA receives about 1,000 annual requests for compassionate use and approves about 99 percent. During a hearing last year Gottlieb told a Congressional panel that most of the experimental treatments provided to terminal patients through the compassionate use program are ineffective in treating the terminally ill patients.
