Governor Wolf signed legislation that gives terminally ill patients the right to try experimental treatments, such as investigational drugs, biological products, and medical devices, not yet fully approved by the FDA.
Pennsylvania House Bill 45 of the 2017-2018 session, was introduced by Representative Bob Godshall, who himself had the opportunity to use an experimental drug. His account appears here. The bill passed unanimously by both the House and Senate.
Eligible patients are those with a terminal illness attested to by their treating physician, unable to participate in a clinical trial, who have a recommendation from their physician to try the investigational product, and have given full informed consent.
The law also gives health care providers immunity when recommending the use of an investigational product and protects them from professional licensure sanctions. Health Care workers are defined by this law as licensed health care facility, or a person who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth, including, but not limited to, a physician, a certified nurse practitioner or a physician’s assistant.
Thirty-seven other states have laws similar to Pennsylvania’s.
The law does not provide for health care coverage for those participating in the experimental treatments, but a manufacturer may elect to provide them to an eligible patient without receiving compensation. To be eligible, the patient may not be treated as an inpatient at any hospital.
Section 3 (1)(v) of the law expands the definition of a “patient” to include parents of a minor and Health Care Representatives or Agents under an Advance Health Care Directive. However, the law seems to expand the “due diligence requirements” of those persons before giving approval.
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Questions for discussion: Can any of the hospice workers/ physicians / or others on this list give insight as to:
Has anyone ever obtained FDA approval under a compassionate-use application for an experimental drug? What was it?
This post is filed under Legal Concerns (laws) affecting seniors.