This week, Right to Try became law of the land. It allows terminal patients, who do not qualify for clinical trials, to access experimental drugs that have not been fully approved by the FDA. This is a victory for patients who will no longer have to wait for government permission to access promising new treatment options. It will cut out government red tape and allow patients to make treatment decisions with their doctor, instead of Uncle Sam.
WHY RIGHT TO TRY?
Currently, federal regulation requires that each individual drug be directly approved by the FDA. The approval process requires 2 types of testing. The first is to show the basic safety of a drug and make sure it is not going to put the patient in toxic shock or equally detrimental conditions. This type of testing intuitively is necessary in the development of a new drug for use in patients. The second type, however, is less obviously important. This other type of testing is meant to show evidence for the drug’s efficacy in treatment. The efficacy testing requires drawn out clinical trials that can take up to a decade to complete.
This archaic approval process is too slow for terminally ill patients. The FDA process has failed these people, facilitating the unnecessary death of thousands of Americans. Right to try allows for drugs, that have passed basic safety testing, to be tried without having to wait for an arbitrarily determined efficacy standard. This streamlined path is crucial for terminal patients who are running out of time.
Critics of Right to Try voice safety concerns for the patients who now will have access to experimental drugs. They often cite the chance of the patient experiencing an adverse drug reaction (ADR) and making their condition worse. However, full FDA approval does not eliminate the possibility that the patient will experience an ADR. It also does not guarantee that the drug will be effective in treating a patient. Absolutely no drug treatment option is completely free from ADR concern, despite its status as approved by the FDA. While right to try doesn’t promise a miracle cure, it does provide hope for those who are otherwise out of options. These patients should be afforded the basic dignity of making the decision that is right for them and their family.
Right to Try laws are positively impacting lives in the 40 states that it has been tried in. The law is an effective policy solution, partly because it began as a state-based initiative. In 2015, Texas became the 21st state to enact Right to Try legislation. Since then those with terminal illnesses in Texas have had more treatment options at their disposal. A Houston-based oncologist has successfully utilized the state Right to Try law in the treatment of 78 cancer patients. The experimental treatment that saved these lives was not fully approved by the FDA and would not have been legally used had Right to Try had not been law in the Lone Star State. This in concert with individual testimonies suggest that Right to Try has been effective in Texas.
Here the states worked effectively as “laboratories of democracy” as famously put by Supreme Court Justice Louis Brandeis. This locally-minded solution has allowed for a clear-eyed perspective on how to address the problem created by government bureaucracy. This perspective has proven itself effective in addressing policy concerns and should be used in the formation of future policy solutions.
The federal Right to Try legislation, signed by president Trump, will succeed in saving lives across the country and is a victory for individual liberty. The FDA process is too slow and has been responsible for the unnecessary death of thousands of people in America. The drugs that qualify for Right to Try have passed basic safety testing are not determined to be dangerous. Above all, this new path affords patients the opportunity to try potentially life-saving drugs and explore all possible treatment options. This provides hope for those who need it most.
Thomas Romeo – Contributor
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