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Petition to the FDA for a Moratorium on Approval of New Opioids or New Opioid Formulations

March 21, 2019 (resubmitted April 10, 2019)

View resubmitted petition as PDF

View original petition, which was withdrawn, as PDF

View cover letter as PDF

View press release

Listen to telephone press conference

Public Citizen petitioned the Food and Drug Administration (FDA) to immediately impose a moratorium on approval of all new drug applications for new opioids or new opioid formulations, not to be lifted until the FDA has implemented the elements recommended by the National Academies of Sciences, Engineering, and Medicine for inclusion in a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the current deadly opioid crisis in the U.S.

April 15, 2019, FDA acknowledgment letter.

September 6, 2019, FDA final response letter.

See Public Citizen’s other work on opioid drug issues.