On Wednesday, President Trump signed the “right-to-try” bill, which now permits terminally ill patients to gain access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA).
The bill was staunchly supported by Trump and Vice President Pence, along with congressional Republicans. In March 2015, Pence, then governor of Indiana, signed a similar bill into law.
Indiana’s law permitted physicians in the state to prescribe a drug that had passed the first phase of the FDA’s three-phase clinical trial process. The three stages work like this: Phase 1 trials are implemented on between 20 to 80 healthy patients to determine their safety and what is a safe dose. Phase 2 trials involve between 100 and 300 people who could gain from the drug therapy; phase 3 trials involve the testing of hundreds and sometimes thousands of patients who would benefit.
As he signed the bill, accompanied by terminally ill patients and their families, Trump stated, “Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it’s going to 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.”
Democrats and public health groups have opposed the bill, arguing that patients would be endangered.
Rep. Frank Pallone Jr. (D-NJ), ranking member of the House Energy and Commerce Committee, said, “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.”
But Energy and Commerce Committee Chairman Greg Walden (R-OR) and health subcommittee chairman Michael Burgess (R-TX) countered, “While a long time coming, today is a monumental win for patients desperately seeking the ‘right to try’ investigational treatments and therapies. With ‘right to try’ being the law of the land, we are confident that the Trump Administration, and FDA Commissioner [Scott] Gottlieb, will take both congressional intent and the safety of patients into consideration when implementing this important law.”