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“RIGHT TO TRY” FAQS

1. If I’m a patient or a physician and I have a question about the Right to Try Act, who do I ask?

The FDA recommends that patients first consult with their physician and that physicians consult with the sponsor of the investigational drug or biological product. The sponsor is in the best position to provide information about whether the drug or biological product meets the criteria to be considered an eligible investigational drug for use under the Right to Try Act. 

2. If I identify a drug that I would like to use under the Right to Try Act, how do I know if it is an “eligible investigational drug”?

The FDA recommends that you consult with the sponsor of the investigational drug or biological product. The sponsor is in the best position to provide information about whether the drug or biological product meets the criteria to be considered an eligible investigational drug for use under the Right to Try Act. 

3. Does the FDA review or approve Right to Try Act requests?

The FDA does not review or approve requests for Right to Try Act use. The FDA’s role is limited to the receipt and posting of certain information submitted under the Right to Try Act. 

4. What does the FDA do with the annual summaries submitted under the Right to Try Act?

The FDA will receive annual summaries from manufacturers or sponsors on the use of an eligible investigational drug under the Right to Try Act. The FDA will post a consolidated annual summary report of Right to Try Act use. 

5. Does an IRB review and/or approve Right to Try Act requests?

Individual Right to Try Act requests do not require IRB (institutional review board) review or approval; however, eligible investigational drugs under the Right to Try Act must meet certain criteria.

6.Is written informed consent required for the Right to Try Act?

Yes, a physician is responsible for getting written informed consent from the eligible patient or their legally authorized representative. 

7.Does the Right to Try Act obligate a sponsor to provide an eligible investigational drug to an eligible patient?

No, the Right to Try Act does not require a sponsor to provide an eligible investigational drug to an eligible patient.

8.If the IND for a drug is on clinical hold, is the drug an eligible investigational drug for use under the Right to Try Act?

No, a drug under IND clinical hold is not an eligible investigational drug and a sponsor cannot provide the drug for use under the Right to Try Act.

The FDA is available to answer questions regarding the Right to Try Act.

Patients with specific Right to Try requests should consult their physician.

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