Right to Try removes government red tape so that you can work directly with your physician and a drug manufacturer to pursue an investigational treatment. However, the law has important eligibility criteria that you must meet in order to access a new treatment.
If you meet these criteria, you’ll need to ask your doctor to help you access a treatment. If the manufacturer agrees, the process is straightforward from there. Here’s how it works:
- Your 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, your doctor and manufacturer will develop a treatment protocol for your specific situation and arrange for the treatment to be provided to the physician.
- Manufacturer determines if cost-recovery is necessary and provides you with the cost. Companies are allowed to charge patients for certain items, but there are strict guidelines in federal law that must be followed, and they cannot make a profit.
- You’ll sign an informed consent document that explains that you understand you are taking an investigational treatment with unknown side effects. Other contents of the document are determined by the laws in the state where your treatment will take place.
- Your physician may have additional notifications to make, but that will be something he or she already knows is required if it applies to them.
- Treatment begins at a time and place that works for you and your doctor.
- The manufacturer will notify FDA within a year that a treatment was made available and report outcome data.
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Here’s a letter to get your doctor started on a request.
You can learn more about treatments that are in FDA Phase 2 or 3 trials at clinicaltrials.gov.
If you or your doctor have questions about the process and steps required, please contact Naomi Lopez-Bauman at (602) 462-5000.