By Michael T. Hamilton
Pennsylvania, one of the first colonies-turned-states to declare unalienable a person's right to life, must act soon to avoid becoming one of the last states to secure for terminally ill patients the right to try to save their own lives.
It is natural for people to try to extend their lives and improve their quality of life, and it is fitting for people whose lives are at risk to do all they can to save themselves. Most will agree people have a fundamental right to do so, provided they exercise this right without encroaching on the rights of others.
These self-evident truths are much on the minds of patients who have received a terminal diagnosis. Unfortunately, many of these people have discovered that exhausting all treatment options is harder to accomplish legally than exhausting all treatment options approved by the U.S. Food and Drug Administration.
The FDA requires manufacturers of drugs and medical devices to obtain approval before making their products available to patients. Many products make it through Phase 1 of FDA testing only to languish in the system. The entire process for approving a drug can take 15 years. Obviously, that's too long for patients who have already received a terminal diagnosis. This period will also prove too long for many people who are currently healthy and who will receive a terminal diagnosis later in life.
Legislation pending before the Pennsylvania Senate - the Right to Try Act, House Bill 1104 - would use state law to help create a path by which manufacturers of experimental drugs and medical devices could offer their partially approved products to eligible patients, many of whom are out of options.
The bill would apply to patients who have received a terminal diagnosis from a physician, considered all treatment options already fully approved by FDA, and consented to experimental treatment recommended by a physician. In addition to giving patients options, the bill would protect physicians who recommend such treatments and the manufacturers who produce them from recrimination for unsuccessful treatment.
Under the bill, patients who opt for such treatments would pay for them unless the drug or medical device manufacturer waives the costs. Patients' insurers would not have to foot the bill.
One objection to right-to-try legislation is that some patients already obtain access to experimental treatments through the FDA's expanded-access program, also called compassionate use. Although the FDA reports that more than 99 percent of applicants gain permission to try investigational new drugs through expanded access, its figures "do not show the number of requests that were squelched because of agency regulations before they were ever filed," according to a 2016 report by the Goldwater Institute, which estimates that only 1 percent of clinical trials leverage the FDA's compassionate-use program. (FDA Commissioner Robert Califf acknowledged the application process' "procedural burdens" when releasing a simplified expanded-access application form on June 2.)
Support for commonsense right-to-try legislation transcends partisan politics. The Pennsylvania House already voted 182-0, with 20 lawmakers abstaining, to approve H.B. 1104 on June 16.
Although passing the Right-to-Try Act in Pennsylvania would not supersede the FDA legal barrier that prevents drug and device manufacturers from offering their products to eligible patients, Congress is considering legislation that would activate state right-to-try laws. The Trickett Wendler Right to Try Act, introduced by Sen. Ron Johnson (R., Wis.) in May, would provide manufacturers and patients with the protection they need to exercise their right to try. The bill builds on its House counterpart, which was introduced last year.
As of June, 30 states had passed right-to-try legislation in anticipation of federal lawmakers eventually catching up. Many states, including New Hampshire, South Carolina, West Virginia, Georgia, and Idaho, passed these laws just this year.
Pennsylvania is one of 19 states whose lawmakers have introduced but not passed right-to-try legislation since 2015. In California, Gov. Jerry Brown vetoed a right-to-try bill in October, but a new bill passed the state Assembly 77-2 in May.
Pennsylvanians have a long tradition of carefully balancing the powers of the federal government with the powers of the commonwealth and of other states. In doing so today, the state's residents can think of more constructive purposes for the federal government than to referee patients, doctors, and medical pioneers.
Terminally ill patients should be free to try to extend and improve their lives. The Pennsylvania Senate should pass the Right to Try Act to ensure that only the federal government, not state officials, is delaying Pennsylvanians' right to try.