WASHINGTON - US President Donald Trump on Wednesday signed a new bill titled "Right to Try" which allows terminally ill patients to seek drugs that are still experimental and not fully approved by the US Food and Drug Administration. "As I proudly sign this bill, thousands of terminally ill Americans will have the help, the hope and the fighting chance -- and I think it's going to be better than chance -- that they will be cured,
that they will be helped, that they will be able to be with their families for a long time, or maybe just for a longer time," Trump said, Xinhua reported.
Under the legislation, patients who are near death, or who have a disease that is likely to lead to severely premature death, have the right to seek drug treatments that remain in clinical trials after passing phase 1 of the FDA approval process.
The House on Tuesday voted 250-169 in favour of the bill, which the Senate passed in August. Advocates for the bill say it opens a door for terminally ill people in states that haven't passed such a law. Critics argue that the legislation disempowers the FDA and won't make it easier for the patients to access these drugs, local media reported.
"This issue is about real people who are terminally ill, facing the end of the line, and want to have one more shot at life," said Starlee Coleman with the Goldwater Institute, a conservative public policy think tank based in Phoenix that supports right-to-try legislation.
Right-to-try laws exist in 40 of US 50 states. With the new federal legislation, Coleman argues, patients in states without these laws could save time accessing experimental treatments by eliminating FDA application requirements.
Opponents of the bill, including over 100 patient and provider advocacy groups, say it won't have a major impact on accessing treatments; on the contrary, it could have a detrimental effect on how the FDA safeguards people's health. It is unclear how many Americans have taken advantage of right-to-try laws because the vast majority of states do not have central reporting requirements, said local media reports, noting that there's no guarantee that insurance companies would pay for these treatments.
Under the legislation, patients who are near death, or who have a disease that is likely to lead to severely premature death, have the right to seek drug treatments that remain in clinical trials after passing phase 1 of the FDA approval process.
The House on Tuesday voted 250-169 in favour of the bill, which the Senate passed in August. Advocates for the bill say it opens a door for terminally ill people in states that haven't passed such a law. Critics argue that the legislation disempowers the FDA and won't make it easier for the patients to access these drugs, local media reported.
"This issue is about real people who are terminally ill, facing the end of the line, and want to have one more shot at life," said Starlee Coleman with the Goldwater Institute, a conservative public policy think tank based in Phoenix that supports right-to-try legislation.
Right-to-try laws exist in 40 of US 50 states. With the new federal legislation, Coleman argues, patients in states without these laws could save time accessing experimental treatments by eliminating FDA application requirements.
Opponents of the bill, including over 100 patient and provider advocacy groups, say it won't have a major impact on accessing treatments; on the contrary, it could have a detrimental effect on how the FDA safeguards people's health. It is unclear how many Americans have taken advantage of right-to-try laws because the vast majority of states do not have central reporting requirements, said local media reports, noting that there's no guarantee that insurance companies would pay for these treatments.