SOLICITOR’S REPORT – THE RIGHT-TO-TRY LAW
House Bill No. 45 known as the “Right-To-Try Act” has been adopted as Act 33 of 2017 (the “Act”) to allow terminally ill patients in Pennsylvania to try experimental treatments not yet approved by the Federal Food and Drug Administration (“FDA”). The FDA approval process takes many years. A manufacturer must first test a proposed drug on animals and then receive an investigational new drug status before conducting three clinical trials on humans. The results of those trials are reviewed by the FDA’s Center for Drug Evaluation and Research before the FDA deems a new drug effective and safe for human use and suitable for marketing. Eligible patients who might not otherwise survive by the time the FDA approves a new treatment of interest to the patient may, under specific conditions, try the experimental drug, device or procedure. That opportunity will result in hope for the patient and the patient’s family and, possibly, a cure for what had been thought to be a terminal illness.
That hope and possible cure is available through the FDA’s compassionate use program (the “Program”) and the authorizations and protections offered to manufacturers and health care providers under the Act. The substantive authorization under the Act is to manufacturers of an investigational drug, biological product or medical device “that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the [FDA] and remains under investigation in a clinical trial approved by the [FDA]” (each, an “IMP”). Such a manufacturer may make available to eligible patients its IMP at cost or without compensation in accordance with the Act and the Program.
The protections offered to health care providers under the Act allow the IMP to be administered to an eligible patient. A health care provider is either a health care facility licensed under the Pennsylvania Health Care Facilities Act or a person licensed, certified or regulated to provide health care services in Pennsylvania including, by example only, a physician, a certified nurse practitioner, or a physician assistant. Accordingly, any protections governed by the Act are to health care providers licensed, certified regulated by the Commonwealth of Pennsylvania.
What are those protections? First, a health care provider “while exercising reasonable care” who recommends and participates in the use by an eligible patient of an IMP “may not be subject to criminal or civil liability, nor be found to have committed an act of unprofessional conduct under any law of this Commonwealth relating to licensure.” Nor may a Pennsylvania licensure board revoke, suspend or otherwise take action against (1) a licensed individual health care provider based solely on that person’s recommendations regarding access to or treatment with an IMP by an eligible patient “so long as the recommendations are consistent with medical standards of care;” or (2) another licensee of the Commonwealth solely for participating in the use of an IMP “in good faith and in accordance with the provisions of this [A]ct.” Further the Act may not be construed as creating a private cause of action against the manufacturer of an IMP or “any other person or entity involved in the care of an eligible patient using [an IMP]” for injuries to the eligible patient from the IMP when the manufacturer or other person or entity “acted in accordance with this [Act], except when the injury results from a failure to exercise reasonable care.”
Assuming the exercise of reasonable care, what else must a health care provider do to comply with the Act? The health care provider must get written, informed consent which is a written document signed by the eligible patient and placed in that patient’s medical record and attested to by the treating physician and a witness that, at a minimum: (1) explains the currently approved products or treatments for the patient’s condition; (2) attests that the patient agrees with the treating physician in believing that all currently approved and recognized treatments are unlikely to prolong the patient’s life; (3) clearly identifies the IMP sought by the patient; (4) describes the best, worst and most likely outcome of using the IMP, including the possibility that new, unanticipated, different or worse symptoms might result, and that death could be hastened; (5) makes clear that the patient’s health insurer and health care provider are not obligated to pay for the IMP; (6) makes clear that the patient’s eligibility for hospice care may be withdrawn when the patient begins the IMP and, reinstated if the use of the IMP ends and the patient is otherwise eligible for hospice care; (7) makes clear that in-home health care may be denied because of the IMP; and (8) states that the patient understands he is liable for all expenses consequent to the use of the IMP, and the liability extends to the patient’s estate, unless a contract between the patient and the manufacturer states otherwise. The precise language for the written consent can be found in the Act.
Who then is an “eligible patient”? Such an individual (1) has a terminal illness attested by the treating physician; (2) has carefully considered FDA approved treatment options for the illness; (3) has been unable to participate in a clinical trial for this illness within 100 miles of the patient’s house or has not been accepted to a clinical trial within a week of completion of the clinical trial application process; (4) has received a recommendation for the IMP by the treating physician; (5) has given the informed consent described above or if a minor, the patient’s parent or legally authorized representative has given such informed consent for the patient; and (6) the treating physician documents that the patient meets eligibility requirements. An eligible patient may not be an individual treated as an inpatient in any hospital.
The FDA’s Program for compassionate care addresses federal matters for which the Act addresses related Pennsylvania legal issues. Under the Program, health care providers and eligible patients obtain FDA approval to use an IMP, and the manufacturer may supply the IMP, outside of a clinical trial. The Program is an exception to premarketing approval requirements for manufacturers under the Federal Food, Drug and Cosmetic Act and the licensing provisions of the Public Health Service Act. An eligible patient must file with the FDA a Form 3926 prescribed by the Program to obtain FDA approval for expanded access to the IMP. More information about the Program can be found at https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm.
The FDA implemented the Program in June 2016 and subsequently, on January 23, 2017, Rep. Bob Godshall (R – Montgomery) introduced HB No. 45. The Act was sponsored by Rep. Bob Godshall in the House and Sen. Chuck McIlhinney (R – Bucks) sponsored the companion SB No. 569 in the Senate. Both the House and Senate passed the Right-to-Try proposal unanimously and Governor Wolf approved the Act on October 11, 2017, effective 60 days thereafter.
© 2017 Robert J. Hobaugh, Jr.