Under the long Food and Drug Administration (FDA) approval process, it takes more than a decade and a billion dollars for new drugs to hit the market. In the meantime, Americans who have exhausted all government-approved options could die waiting to gain access to these potentially life-saving new treatments.
Often, Americans are denied access to the same drugs that are already helping patients overseas, even though many of these treatments were developed or produced in the United States. For example, lutetium-177 has been shown in clinical trials to significantly slow the growth of neuroendocrine cancer. It is inexcusable that the drug, produced in Missouri and compounded in Texas, is only available to Texans if they are lucky enough to participate in a clinical trial or if they can travel to Europe where the treatment is widely available.
Beyond Washington’s stalemate, there is hope in the states. The right to try, now in effect in 21 states, allows people who are terminally ill to try experimental drugs that have passed FDA Phase 1 safety testing but are not yet fully approved for use. the market.
The FDA has its own compassionate use program aimed at providing access to therapies still under evaluation – however, enforcement is cumbersome, largely unfeasible for practicing physicians, and time consuming when a patient’s time is counted. State right-to-try laws give patients who have exhausted all government-approved options another chance to fight for their lives. The laws seek to reduce the often two to four month waiting period under FDA compassionate use to two to four weeks, and possibly two to four days.
In their recent Publish for Health Affairs Blog, David Farber, Preeya Noronha Pinto, Arthur Caplan, and Alison Bateman-House say these state laws “create false expectations” because “[f]Federal preemption laws prevent states from creating “workarounds” like Right to Try.
But federal regulations that violate constitutional freedoms can never override state laws. The United States Constitution provides a floor of protection for individual rights, not a ceiling. The father of the Constitution, James Madison, wrote that our system of federalism offers “double security. . . to the rights of the people”. In other words, the 50 states serve as shields for individual rights that the federal government does not protect. States can harness these tools to protect the most personal and intimate right of all – the right to try to save one’s life.
Although the FDA regulates the introduction of drugs and medical devices into the marketplace, these regulations cannot override state laws that preserve constitutionally protected rights, such as the right to life and self – medical preservation.
The Constitution protects a person’s freedom of choice in medical care, including the right to refuse unwanted medical treatment and rights preserving the doctor-patient relationship. It must therefore certainly protect a person’s decision, made in collaboration with their doctor, to try promising treatments that may to save his life.
The Supreme Court has long recognized a person’s constitutionally protected liberty interest in their own medical autonomy, particularly when those interests are guaranteed by state law. Time and again, the Court has held that states have wide latitude to regulate health and safety, including medical standards, which is primarily and historically a matter of local concern.
The scope of a state’s inherent authority over the practice of medicine includes the power to decide which medical procedures are acceptable and to specify the conditions under which a medical procedure may be lawfully performed. State right-to-try laws regulate the conditions under which a patient is eligible for experimental drugs and a doctor can prescribe experimental treatments, if the manufacturer is willing to provide them.
Additionally, the Supreme Court has demonstrated its commitment to relying on state solutions that protect individual rights, such as the power of states to enact so-called “right to die” laws for terminally ill patients, to control how criminal activity is punished within their borders, ensuring marriage equality and preserving state autonomy over health care programs.
When terminally ill patients lack time and options and face the associated risks, patients – not bureaucrats – should have the freedom to choose the types of treatments they are willing to try, in collaboration with their doctors, their families and loved ones. Fortunately for American patients, this freedom is not protected by a Constitution, but by 51.
The core of freedom is autonomy, and there is no stronger freedom than the autonomy to try to save one’s own life. Right to Try takes the most intimate personal decisions out of the hands of bureaucrats and puts them where they belong: with doctors and their patients.