Kristie L. Kahl
After patients have exhausted all therapeutic options in their cancer treatment, oftentimes there is nowhere left for them to turn. Despite a terminal diagnosis, some patients may have more options in their remaining days if one bill is passed – if only it were that easy.
Right To Try legislation allows patients who are terminally ill to try experimental drugs that have passed preliminary testing in phase 1 of the Food and Drug Administration (FDA) approval process. These are drugs that remain in clinical trial with the FDA and are awaiting approval, but they are not available to all patients.
According to righttotry.org
, the FDA approval process can take up to 15 years. Some of these therapies are already available overseas, however, treatment would require patients to travel to such countries in order to access them. The Right To Try legislation is designed to expand access of these potentially life-saving drugs years before patients would have the option of being treated with them.
Last year, the Senate passed the bill by unanimous consent. Currently, Right to Try legislation is already a law in 38 states and under consideration in 12 more.
In President Donald Trump’s State of the Union address given on Jan. 30, he urged Congress to pass the bill, saying, “We also believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives.”
“People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home,” the President added. “It’s time for Congress to give these wonderful, incredible Americans the right to try.’”
This bill, of course, does not come without controversy.
Supporters of the bill have voiced their concern that federal legislation is needed to combat patient fears regarding the fact that federal government could override the current 38 state regulations.
Similarly, those who oppose the bill have voiced concerns, too, saying the use of these unapproved FDA drugs would bypass the agency’s authority. In addition, access to these agents could have an impact on pharmaceutical companies in undermining drug development and patient safety. Lastly, this bill would not necessarily mean patients will definitely have access to these drugs because pharmaceutical companies are not required to provide them.
The American Cancer Society Cancer Action Network (ACS CAN), an organization that works on policy and legislative issues, is among the group of opponents who do not believe this legislation would successfully increase access to promising investigational therapies for those in need.
“Removing the FDA from this process is not likely to facilitate increased access to investigational therapies because the FDA currently approves 99.7 percent of all expanded access requests submitted by physicians and companies for patients with immediately life-threatening illnesses who cannot participate in clinical trials,” Keysha Brooks-Coley, Vice President of Federal Affairs for the ACS CAN, said in a statement issued to CURE
Currently, the FDA does have a solution in place, called the compassionate-use program, where physicians may apply to receive FDA approval for a seriously ill patient to access the investigational drug in clinical trial.
“Existing expanded access policies are not without room for improvement,” Brooks-Coley added. “We encourage Congress to review other policy options, and we stand ready to serve as a resource as Congress examines this important issue.”
Brooks-Coley added to the argument, noting that pharmaceutical companies generally deny requests under the compassionate-use program for rational reasons. For example, requests could be denied if the benefits do not outweigh the risks associated with the drug, if there is not a sufficient amount of the product to offer outside of clinical trials, if it is too costly for the company, or if it could affect clinical trial enrollment.
“It is important to remember that the current regulatory system for medical products and research in the United States was created as a result of serious patient harm and exploitation that occurred early in the 20th Century,” said Brooks-Coley. “Clinical research subject protections are in place when experimental products are being tested to ensure the safe and ethical treatment of research participants. Patients seeking expanded access to unapproved therapies outside of clinical trials must be afforded the same ethical standards and protections as patients taking part in clinical trials.”