Physicians and manufacturers are not required to treat patients under the Right to Try law. But, if you agree that an investigational treatment might be a good fit for the patient, you can work directly with each other to design a treatment protocol and begin treatment. Here’s how it works:
- Physician contacts manufacturer of investigational treatment in FDA Phase 2 or 3 trial and asks for treatment under the Right to Try law.
- If the manufacturer agrees, the doctor and manufacturer will develop a treatment protocol for the patient and arrange for the treatment to be provided to the physician.
- Manufacturer determines if cost-recovery is necessary and provides cost to patient, following existing federal regulations on cost recovery for unapproved treatments.
- Patient signs an informed consent document, with contents dictated by state law where the treatment will take place.
- Physicians comply with any required notifications or approvals of their IRB, if applicable.
- Treatment begins at a time and place that works for the physician and patient.
- Manufacturer notifies FDA within a year that a treatment was made available and reports outcome data.
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Physicians: Here’s a letter to get you started.
Manufacturers: if you’d like to talk through any legal concerns, please contact Christina Sandefur at (602) 462-5000.