Donald Trump Signs 'Right-To-Try' Bill That Lets Terminally Ill Patients Try Experimental Treatments
On Wednesday, May 30, President Donald Trump signed into law an act meant to provide more options for terminally ill patients. The "Right-To-Try" act is aimed to give them access to a wider range of drug treatments, especially those that have not yet been approved by the Food and Drug Administration.
The new bill will give patients deemed terminally ill a chance to avail of therapies that are still in clinical trials, even if they have not yet been fully endorsed by the FDA. The only requirement is that these drug treatments should "have passed Phase 1 of the Food and Drug Administration's approval process," according to CNN.
Trump was surrounded by patients and their families during a ceremony at the White House, where he signed the bill into law.
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"America is a nation of fighters. We never give up, right?" Trump said to the onlookers, before handing the pen that he used to Jordan McLinn beside him, who is a 9-year old boy suffering from a terminal form of muscular dystrophy.
The new bill still has a requirement that the patients must have already exhausted their other options when it comes to approved treatments and clinical trials. While patients were able to submit petitions to the FDA to get access to non-approved drugs, with 99 percent of applications granted since 2009, this new bill will make these requests unnecessary.
When it comes to the point of resorting to treatments still in FDA trials, the new bill also shields doctors and companies from legal risks that come with unapproved therapies, as long as they do not intend to harm the patient, according to BBC.
FDA Commissioner Scott Gottlieb, himself a cancer survivor as well as a physician, has expressed that the agency is prepared to put the bill into effect. Even then, he still cautions those who want to try treatments that are not yet fully approved by the FDA.
"The clinical trial process is crucial to the development of innovative new medical products that can improve or save patients' lives," he emphasized in a statement made to the Congress last year.
Advocacy groups like the American Cancer Society and other opponents of the bill counter that the new legislation will not change much when it comes to access to unapproved drug treatments, but will instead have a negative effect on the FDA's efforts to safeguard the public through its strict approval process.
Clinical trials for drugs usually means years of testing, and only around 70 percent of drugs move past the first stage. Ultimately, only around 33 percent of drugs proposed make it past phases where the FDA asks for proof that the drugs are effective with minimal side effects.
