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It’s time to explore the evolution of the “Right to Try” movement. Originally presented as a way for desperately ill patients to gain access to developmental medicines outside of the Food and Drug Administration (FDA) process, Right to Try laws have proven to be a dud. After all the fuss and bother by politicians and pundits, the number of patients receiving treatment via this new pathway can be counted on the fingers of one hand—with enough fingers left to type this commentary.
To sum it up, the Right to Try movement is failing because it is based on four fallacies.
Fallacy No. 1: The FDA Was a Bottleneck to Patients Seeking Experimental Treatment
Many have blamed the FDA for impeding patients’ searches for experimental treatment options, but the facts speak otherwise. Over the last five years, the FDA has authorized more than 9,000 applications across drugs, biologics and devices through the agency’s Expanded Access program. Furthermore, the agency has authorized approximately 99 percent of all the requests received, across all application types.
The fact that the FDA’s volume of Expanded Access applications has increased since the passage of state and federal Right to Try legislation speaks to the robustness of the agency’s program and the importance of the Right to Try concept. However, it isn’t a tremendous leap of faith to say that it’s been mainly media attention that has helped communicate to patients, caregivers and physicians this better, speedier FDA pathway.
Fallacy No. 2: Right to Try Means Drug Developers Are Required to Provide Their Medicines to Patients Upon Request
According to Senator Ron Johnson (R-Wis.), one of the prime forces behind the federal Right to Try Act, “Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives.” Fine words, but this isn’t what the actual legislation calls for; drug developers can accept or deny a request under Right to Try laws for any reason. “Right to Ask” doesn’t have the same rhetorical resonance, but that’s the reality.
Right to Try also doesn’t mean patients have the right to try—for free. While, the FDA limits what can be charged for an experimental medicine (raw materials, labor and non-reusable supplies and equipment needed to make the quantity of drug required for the patient’s use—or costs to acquire the drug from another manufacturing source, plus shipping and handling), Right to Try allows pricing to be a potential profit center.
It’s time to explore the evolution of the “Right to Try” movement. Originally presented as a way for desperately ill patients to gain access to developmental medicines outside of the Food and Drug Administration (FDA) process, Right to Try laws have proven to be a dud. After all the fuss and bother by politicians and pundits, the number of patients receiving treatment via this new pathway can be counted on the fingers of one hand—with enough fingers left to type this commentary.
To sum it up, the Right to Try movement is failing because it is based on four fallacies.
Fallacy No. 1: The FDA Was a Bottleneck to Patients Seeking Experimental Treatment
Many have blamed the FDA for impeding patients’ searches for experimental treatment options, but the facts speak otherwise. Over the last five years, the FDA has authorized more than 9,000 applications across drugs, biologics and devices through the agency’s Expanded Access program. Furthermore, the agency has authorized approximately 99 percent of all the requests received, across all application types.
The fact that the FDA’s volume of Expanded Access applications has increased since the passage of state and federal Right to Try legislation speaks to the robustness of the agency’s program and the importance of the Right to Try concept. However, it isn’t a tremendous leap of faith to say that it’s been mainly media attention that has helped communicate to patients, caregivers and physicians this better, speedier FDA pathway.
Fallacy No. 2: Right to Try Means Drug Developers Are Required to Provide Their Medicines to Patients Upon Request
According to Senator Ron Johnson (R-Wis.), one of the prime forces behind the federal Right to Try Act, “Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives.” Fine words, but this isn’t what the actual legislation calls for; drug developers can accept or deny a request under Right to Try laws for any reason. “Right to Ask” doesn’t have the same rhetorical resonance, but that’s the reality.
Right to Try also doesn’t mean patients have the right to try—for free. While, the FDA limits what can be charged for an experimental medicine (raw materials, labor and non-reusable supplies and equipment needed to make the quantity of drug required for the patient’s use—or costs to acquire the drug from another manufacturing source, plus shipping and handling), Right to Try allows pricing to be a potential profit center.
