President Donald Trump signed the recently-passed ‘Right to Try Act,’ which will give terminally ill patients the right to seek access to medications that have yet to be approved in order to save their lives.
President Donald Trump signed the recently-passed ‘Right to Try Act,’ which will give terminally ill patients the right to seek access to medications that have yet to be approved in order to save their lives.
Trump has long been a supporter of the legislation that took multiple attempts to pass. During the signing ceremony on Wednesday, Trump said he believes “hundreds of thousands” of lives will be saved as a result of this legislation, CNN reported. He said that the bill will give patients “hope where they had none before,” CNBC said.
“With the passage of this bill, Americans will be able to seek cures,” Trump said, according to reports.
The president also said that he never understood why previous administrations have not passed the legislation, CNN added.
The legislation, which cleared Congress earlier this month, 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. The appealing patients would not be considered part of the clinical trial and any adverse reactions to the experimental medications taken by the terminally ill patients will not affect clinical review.
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 from the process.
Before the legislation was approved patients would be required to appeal to the FDA for access to the experimental medications through the agency’s compassionate use program. The program has been put in place as “a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions,” the FDA said. BioSpace previously reported that the FDA receives about 1,000 annual requests for compassionate use and approves about 99 percent of the time.
While the president signed the legislation into law, there are hurdles that will have to be overcome, including who pays for the experimental treatment the terminally ill patients are seeking. Another hurdle will be getting the pharmaceutical companies to sign off on allowing patient access. The legislation does not compel the companies to provide the medication.
Speaking to CNBC earlier this year FDA Commissioner Scott Gottlieb said one issue the agency has run into with the compassionate use program is that many of the drugmakers do not have excess medications lying around for additional use. The companies have developed enough for their clinical trials and no more, he said.
“They don’t have a lot of excess supply available… so I think there are going to be significant supply constraints to getting access,” Gottlieb said.
