At the core of the right-to-try issue is government interference in individual decision-making. Currently, patients only have access to drugs that have been approved by the FDA. But recently, thirty-eight states have enacted right-to-try laws, which allow patients to have greater control over their own lives. These laws grant terminally ill patients who cannot participate in clinical trials and have exhausted all other options access to medical treatments which have not yet received FDA approval. These treatments must have also passed initial screening by the agency and must be administered by a doctor.
The government should not be able to prevent terminally ill patients from making such choices. Currently, FDA has expanded access or “compassionate use” policies, intended to give patients access to treatments yet to be approved. However, patients and their physicians must apply to the FDA for this access, and the application process can be extremely difficult and time-consuming. Even if patients are approved for expanded access, why should a terminally-ill individual need permission from the government to seek potentially life-saving treatment?
If patients and their physicians believe that they could benefit from an experimental treatment, are willing to assume the costs, and are able to access the treatment, the government should not be able to block their choice. No patient, medical professional, or manufacturer is compelled to seek or provide treatment under the state right-to-try laws; right-to-try is voluntary. Under these laws, a patient must sign a consent form indicating that they understand the risks assumed and that the medical professional and manufacturer agree that the treatment could benefit the patient.
One prominent argument against right-to-try is that it will make clinical trials more difficult to conduct and severely reduce the number of those enrolled. Presently, patients may apply for enrollment in a clinical trial, but that does not guarantee that they will be approved or enrolled in these trials. Moreover, if a patient is enrolled in a single- or-double-blind trial, those in a control group might not receive treatment even after completing the approval process. In the Right to Try Act currently under consideration by the House, the only patients who will be eligible to use investigational drugs are those who are ineligible for clinical trials. Additionally, the treatments that patients will be able to access must have already passed the FDA’s safety testing phase. By the bill’s own terms, clinical trials will not be eliminated. Rather, right-to-try will provide an alternative avenue to—or even complement—clinical trials.
The FDA approval process for new pharmaceutical medications takes an average of twelve years from pre-clinical testing to final approval. Thus, a question emerges: if the FDA approves a drug that will save lives today, how many patients died yesterday waiting for FDA to act? A series of CEI studies illustrate how FDA approval delays result in the phenomenon of “drug lag.” Related to this, polls conducted by CEI revealed that a significant portion of physicians across various fields believe the FDA is too slow in its approval process. Clearly, the approval process needs to be made more efficient, and right-to-try laws would provide an avenue for terminally-ill patients to promptly access potentially life-saving medications. The Right to Try Act has already passed the Senate and the House should swiftly consider this legislation in order to give suffering patients an additional option for treatment and remove some of the cumbersome red tape.
CEI supports the principles behind right-to-try laws, as they promote human dignity, basic human rights, and limited government.
>> Read the coalition letter signed by CEI in support of S. 204, the Right to Try Act here.