"Right to Try" State Model Legislation

The Goldwater Institute of Arizona has designed state model legislation, known as a "Right to Try" bill, which would make experimental drugs available to terminally-ill patients without the FDA's approval. Under this legislation, a patient with "an advanced stage of a disease with an unfavorable prognosis and no known cure" could obtain an experimental drug that has passed initial toxicity and dosage testing (Phase I clinical trial) with the permission of their physician and the drug manufacturer. 

The model state legislation provides parameters for patient eligibility, including:

  • Terminal illness;
  • Consultation with a physician, including consideration of all other treatment options currently approved by the FDA;
  • Prescription or recommendation by a physician for an investigational drug, biologic product or device; and
  • Informed consent in writing (if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or guardian may provide informed consent on a patient's behalf).

There is no requirement for the manufacturer to provide an investigational drug for these purposes and it may require an eligible patient to pay the costs associated with manufacturing the product. Additionally, insurance companies are not required to provide coverage for any of the costs of purchasing an investigational drug under this approach. The legislation also protects any physician from losing their medical license due to the potential negative effects of prescribing an investigational drug. 

As of June 6, 2014, Louisiana and Colorado have recently enacted "Right to Try" legislation, Missouri's version has cleared the legislature, and voters in Arizona will consider the "Right to Try" proposal on a ballot initiative in November.  It is anticipated that there will be legal challenges to these state laws that contend, among other things, that the federal laws that the FDA enforces pre-empt the "Right to Try" state statutes. 

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Comment by Chris Diemler on June 16, 2014 at 4:10pm
I live in Missouri and I am happy to see this, but how many in our community can realistically pay for exon skipping out of pocket? Or probably any gene therapy treatment for that matter.
Comment by David on June 16, 2014 at 11:55am
Seems like a lawyers solution...which means it works only to create lawsuits.
What drug sponsor is going to agree to this? If they are already investing in the trial why would they risk giving doses to a non participant? I mean I love the idea behind this but it doesn't seem practical at all.

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