Under the Food and Drug Administration’s (FDA) lengthy approval process, it takes over a decade and a billion dollars for new medicines to get to market. In the meantime, Americans who have exhausted all government-approved options may die waiting for access to these new potentially lifesaving treatments.
Often, Americans are denied access to the same medicines that are already helping patients overseas, even though many of those 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 readied in Texas, is only available to Texans if they are lucky enough to be in a clinical trial or if they can travel to Europe where the treatment is widely available.
Beyond the Washington impasse, there is hope in the states. Right to Try—now law in 21 states—allows the terminally ill to try investigational medications that have passed FDA Phase 1 safety testing but are not yet fully approved for market.
The FDA does have its own Compassionate Use program aimed at providing access to therapies still under evaluation — however the application is cumbersome, largely unworkable for practicing physicians, and time consuming when a patient’s time is running out. State Right-to-Try laws give patients who have exhausted every government-approved option another chance to fight for their lives. The laws are aimed and reducing the often two to four month waiting period under the FDA’s Compassionate Use down to two to four weeks, and eventually two to four days.
In their recent post for Health Affairs Blog, David Farber, Preeya Noronha Pinto, Arthur Caplan, and Alison Bateman-House claim these state laws “create false expectations” because “[f]ederal preemption laws prevent states from creating workarounds” like Right to Try.
But federal regulations that violate constitutional liberties can never trump state laws. The U.S. Constitution provides a floor of protection for individual rights, not a ceiling. Father of the Constitution James Madison wrote that our system of federalism provides “a double security . . . to the rights of the people.” In other words, the 50 states serve as shields for individual rights that the federal government fails to protect. States can harness these tools to protect the most personal, intimate right of all — the right to try to save one’s life.
While the FDA regulates the introduction of drugs and medical devices into the market, those regulations cannot preempt state laws that preserve constitutionally protected rights, such as a person’s right to life and medical self-preservation.
Freedom Of Choice
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. Certainly, then, it must protect a person’s decision—made in conjunction with his or her doctor—to try promising treatments that may save his life.
The Supreme Court has long recognized a person’s constitutionally protected liberty interest in his or her own medical autonomy, especially when those interests are secured by state laws. Time after time, the Court has held that states have great latitude in regulating health and safety, including medical standards, which are primarily and historically a matter of local concern.
Deference To States
The scope of a state’s inherent authority over the practice of medicine includes the authority to decide which medical procedures are acceptable to perform and to specify conditions under which a medical procedure may be lawfully performed. State Right-to-Try laws regulate conditions under which a patient is eligible for investigational drugs and a doctor may prescribe investigational treatments, if the manufacturer is willing to provide them.
Moreover, the Supreme Court has demonstrated a commitment to deferring to state solutions that protect individual rights, such as states’ powers to enact the so-called “right-to-die” laws for terminal patients, control the way criminal activity is punished within their borders, ensure marriage equality, and preserve state autonomy over health care programs.
When the terminally ill are out of time and options and presented with the associated risks, patients—not bureaucrats—should have the freedom to make the choice about what types of treatments they are willing to try, in conjunction with their doctors, families, and loved ones. Luckily for American patients, this freedom is protected not by one 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 hands of bureaucrats and puts them back to where they belong: with doctors and their patients.
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