President Trump signed the controversial “right to try” bill on Wednesday, which will allow terminally ill patients to access experimental treatments without going through the Food and Drug Administration, according to CNBC. The measure has earned support from Trump and Vice President Pence, as well as many Republicans in Congress, and passed but the House of Representatives last week after being approved by the Senate last August.
Supporters argue that it will provide hope for patients who have exhausted other options. At a White House ceremony, Trump signed the bill, surrounded by terminally ill patients and their families, saying:
“Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it’s going to be better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time.”
The bill lets some patients go directly to drug manufacturers to try treatments that have passed Phase 1 of the FDA’s testing, but still face further testing to be approved. To qualify, the patient must have tried all other available options and be unable to join a clinical trial. Even in these cases, companies can opt not to allow patients to try the drugs.
Those who oppose the bill, including most Democrats and public health groups, warn that the move could weaken the FDA’s ability to regulate what medicines are used by patients, allowing them to take drugs that could be ineffective or even harmful.
“FDA oversight of access to experimental treatments exists for a reason — it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good,” according to New Jersey representative Frank Pallone Jr., a Democrat.
The FDA already offers an “expanded access” program that allows patients to apply to try experimental treatments. According to FDA commissioner Scott Gottlieb, 99 percent of those requests are approved. The new bill, however, will cut the agency out of the process altogether.
In a statement, Gottlieb says the FDA is prepared to implement the new policy:
“The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines.”
Two Democrats did co-sponsor the bill, including Senator John Donnelly of Indiana, and Senator Joe Manchin of West Virginia.
At the signing ceremony, Trump thanked Donnelly for his work on the bill, despite having called him a “really incredible swamp person” earlier this month.