An 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 FDA
— FDA
And there you have it. In a strange twist of fate, “right to try” does not apply to hydroxychloroquine and ivermectin because they are already approved and licensed. But COVID-19 patients should not need to cite the Right to Try Act. Hydroxychloroquine and ivermectin may not be specifically approved for use in treating COVID-19, but they don’t need to be. Doctors can utilize the FDA’s off-label policy to prescribe hydroxychloroquine and ivermectin to COVID-19 patients as they see fit.
Sources:
- May 30, 2018. Ron Johnson. “S.204 – 115th Congress (2017-2018): Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.” Legislation. Congress.Gov. 2017/2018.
https://www.congress.gov/bill/115th-congress/senate-bill/204.
Government. - January 14, 2020. “Right to Try.” US Food & Drug Administration.
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try.
Food & Drug Administration. - May 30, 2018. “Trump Signs ‘Right to Try Act.’” USA TODAY. Runtime of embedded video: 1:37.
https://www.usatoday.com/videos/news/politics/2018/05/30/trump-signs-right-try-act/35507363/.
News, Video. - May 30, 2018. Goldwater. “President Trump Signs Right to Try Act Into Law.” Right to Try – National Movement.
http://righttotry.org/president-trump-signs-right-to-try-act-into-law/.
Activist.
Related:
- April 18, 2019. US Food & Drug Administration. “Understanding Unapproved Use of Approved Drugs ‘Off Label.’”
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label.
Food & Drug Administration.
