Last week, the House of Representatives passed a piece of legislation that some consider highly controversial. Called the “Right to Try Act,” it would allow patients with terminal illnesses to receive experimental medication without the approval of the Food and Drug Administration (FDA).
The Senate passed the bill in August 2017, with the House passing it after the White House urged them on, most recently noted in a Monday statement.
“Far too many patients in our country are faced with terminal illnesses for which there are no treatments approved by the Food and Drug Administration (FDA),” the White House statement reads. “The Administration believes that these patients and their families should be able to seek access to potentially life-saving therapies while those treatments are still under review by the FDA.”
President Donald Trump is expected to sign the bill quickly, according to a report from The Scientist.
Critics of the measure claim that patients will become vulnerable to “con-artists.” Democratic Congressman Frank Pallone (NJ-6) argued on the floor of the House that by removing FDA supervision of experimental drugs in medical procedures it would, “provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients.”
According to the bill, H.R. 878, the one who would be administering these experimental drugs is a, “physician, who is in good standing with the physician’s certifying organization or board.” The bill does not relax any types of the required licensing or certifications a physician must have to administer medicine, even experimental.
Furthermore, these experimental drugs are not just hodgepodges of random ingredients from the kitchen cabinet. They are drugs which have, “…successfully completed a phase 1 clinical investigation…remain[s] under investigation in a clinical trial approved by the Food and Drug Administration,” according to the legislation.
When a new medication is developed by a pharmaceutical company it goes through three phases of testing and clinical trials that take years to complete before it is available to physicians to use on patients. The first phase of trials requires a company to prove the drug is relatively safe for humans – basically the drug itself will not poison the patient. Later phases are used to determine is relative effectiveness and side effects.
By passing the Right to Try Act, terminally-ill patients will now have the right to use potentially lifesaving medications that have not gone through rigorous testing; like those whom suffer with amyotrophic lateral sclerosis (ALS). Although the promises given by right-to-try advocates may outweigh the eventually beneficial impact of the measure, it still brings hope to some who have exhausted all other available treatment options
For terminally-ill patients, even if the new legislation leads to just one patient being saved from a previously incurable disease, it is worth it.
