Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Learn About Expanded Access and Other Treatment Options

Learn About Expanded Access and Other Treatment Options

                        Right to Try
          Understanding Investigational Drugs
          Right to Try Annual Reporting Summary


                        Understanding Unapproved Use of Approved Drugs "Off Label" Home
          For Patients
          Learn About Expanded Access and Other Treatment Options
          Right to TryLearn About Expanded Access and Other Treatment Options Right to Try
  
  	
    Share
    Post
    Linkedin

    Email
    PrintThe FDA published a final rule, Annual Summary Reporting Requirements Under the Right to Try Act, which specifies the deadline and content for annual reports by sponsors or manufacturers who provide an eligible investigational drug under the Right to Try Act. Manufacturers or sponsors who have participated in the Right to Try program should submit annual reports to RTTAnnualReports@fda.hhs.gov. Sponsors may use the Right to Try annual reporting form.


FDA Right to Try Fact Sheet

The Right to Try Act is one way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain investigational treatment options. FDA’s role in implementing the Right to Try Act is limited to receiving and posting certain information submitted to the agency.

For patients with serious or immediately life-threatening diseases or conditions, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access investigational medical products through clinical trials. This is the mission of our expanded access program. The agency is dedicated to these purposes, and it has been for more than three decades.

The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.

A patient who is eligible for Right to Try is a patient who has:

Been diagnosed with a life-threatening disease or condition
	Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
	Provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physicianAn eligible investigational drug is an investigational drug:

For which a Phase 1 clinical trial has been completed
	That has not been approved or licensed by the FDA for any use
	For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
	Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDAIf you are interested in Right to Try, you should discuss this pathway with your doctor. Companies who develop and make drugs and biologics can provide information about whether their product is considered an eligible investigational drug and whether they are able to provide the product under the Right to Try Act. Ultimately, companies developing drugs for life-threatening diseases or conditions are responsible for determining whether to make their products available to patients who qualify for access under the law.

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?***

A: 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”?***

A: FDA recommends 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.

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

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

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

A: FDA will receive annual summaries from manufacturers or sponsors on use of an eligible investigational drug under the Right to Try Act. 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?***

A: Individual Right to Try Act requests do not require IRB 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?***

A: 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?***

A: No, the Right to Try Act does not require a sponsor 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?***

A: 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.

***9. I am a sponsor or manufacturer who has provided an eligible investigational drug under the Right to Try Act.  What are my annual reporting responsibilities?***

A: The FDA has published a final rule that specifies the deadline and content for submission of an annual report of eligible investigational drugs supplied under the Right to Try Act. Mandatory reporting includes:

The name of the eligible investigational drug
	The IND (Investigational New Drug) number
	The number of doses supplied
	The number of patients treated
	The disease or condition that the drug is intended to treat; and
	Information on serious adverse events***10. I am a sponsor or manufacturer who has provided an eligible investigational drug under the Right to Try Act. How should I submit my annual report?***

A: A Right to Try annual reporting form is available.  Submit annual reports to RTTAnnualReports@fda.hhs.gov by March 31 annually as detailed in the final rule.



Resources

Annual Summary Reporting Requirements Under the Right to Try Act
	Right to Try annual reporting form
	Expanded access programContact

FDA is available to answer questions regarding the Right to Try Act. Patients with specific Right to Try requests should consult their physician.
	For investigational drugs, contact druginfo@fda.hhs.gov or 301-796-3400.
	For investigational biologics, contact industry.biologics@fda.hhs.gov or 240-402-8020 or 800-835-4709.
	For annual reporting requirements, contact RTTannualreports@fda.hhs.gov.
	For general questions, or if you are unsure, contact patientaffairs@fda.hhs.gov or 301-796-8460.

                                                                                  Content current as of:
      01/23/2023Learn About Expanded Access and Other Treatment Options

          
                        Right to Try
          Understanding Investigational Drugs
          Right to Try Annual Reporting Summary


                        Understanding Unapproved Use of Approved Drugs "Off Label"
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop