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FDA Denies Public Citizen Petition Asking for a Moratorium on All New Opioid Approvals

In a seven-page response, the FDA denied an April 10, 2019 petition asking the Agency to place a moratorium on the approval of any new opioid products.  The petition by Public Citizen spoke of the public health opioid crisis and asked that the moratorium be continued “until FDA has implemented recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM) regarding FDA’s framework for making regulatory decisions regarding opioids in NASEM’s 2017 report Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (NASEM Report).”

The FDA denied the petition, stating that the statutory and regulatory framework for the approval of new drug applications does not permit a blanket moratorium on product approval, but that each application is judged on its own merit.  The FDA also noted that even if an application for a new opioid is approved as safe and effective, the review of the product’s safety and efficacy does not stop at the date of approval but rather continues over the life of the marketed product.  The FDA can take appropriate action to modify its labeling, institute an appropriate or more restrictive REMS program, or even remove the product from the market if it no longer is deemed safe and effective.

You can read the petition and the FDA denial here.  It was not unexpected as the FDA process is designed to review and approval new products only after they reach an independent decision regarding the safety or efficacy of the product.  In addition, placing a moratorium on approval could deprive health care providers and patients of advances or improved products to treat severe pain.