In 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 may die while waiting for 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 prepared in Texas, will only be 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 the Washington standoff, there is hope in the States. The Right to Try, now law in 21 states, allows terminally ill people to try investigational drugs that have passed FDA Phase 1 safety tests, but are not yet fully approved for use. Marlet.
The FDA has its own compassionate use program to provide access to therapies that are still under evaluation. State laws on the right to try give patients who have exhausted all government-approved options another chance to fight for their lives. The laws aim to reduce the waiting period often from two to four months under the FDA’s compassionate use to two to four weeks, and possibly to two to four days.
In their recent Publish for Health affairs Blog, David Farber, Preeya Noronha Pinto, Arthur Caplan and Alison Bateman-House claim that these state laws “create false expectations” because “[f]Federal pre-emption laws prevent states from creating “workarounds” like the right to try.
But federal regulations that violate constitutional freedoms can never prevail over state laws. The United States Constitution provides a floor of protection for individual rights, not a ceiling. Father of the Constitution James Madison wrote that our system of federalism offers “double security. . . 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 use these tools to protect the most personal and intimate right of all – the right to try to save your life.
While the FDA regulates the introduction of drugs and medical devices to the market, these regulations cannot override state laws that preserve constitutionally protected rights, such as a person’s right to life and to medical self-preservation.
The Constitution protects a person’s freedom of choice in health care, including the right to refuse unwanted medical treatment and rights preserve the doctor-patient relationship. It is therefore certain that it must protect a person’s decision – taken in collaboration with his doctor – to try promising treatments that may save his life.
The Supreme Court has long recognized the constitutionally protected interest in a person’s liberty in its own medical autonomy, especially when those interests are guaranteed by state laws. On many occasions the Court has tenuous that states have a large latitude by regulating health and security, including medical standards, which are mainly and historically a matter of local interest.
The extent of a state’s inherent authority over the practice of medicine includes the authority to decide which medical procedures are acceptable to be performed and to specify the conditions under which a medical procedure can be legally performed. State laws on the right to trial govern the conditions under which a patient is eligible for investigational drugs and a physician may prescribe investigational treatments, if the manufacturer is willing to provide them.
In addition, the Supreme Court has demonstrated its commitment to rely on state solutions that protect individual rights, such as powers of states to adopt so-called “right to die” laws for terminally ill patients control how criminal activity is punished within their borders, ensure marriage equality, and to preserve state autonomy over health care programs.
When the terminally ill run out of time and options and are faced with the associated risks, patients – not bureaucrats – should have the freedom to choose the types of treatments they are willing to try, including collaboration with their doctors, families and loved ones. Fortunately for American patients, this freedom is not protected by a single Constitution, but by 51.
The heart of freedom is self-reliance, and there is no greater freedom than the autonomy to try to save your own life. Right to Try takes the most intimate and personal decisions of bureaucrats and puts them in their place: with doctors and their patients.