The FDA has declined a citizen petition requesting that the agency impose a moratorium on approval of all new drug applications (NDAs) for new opioids or new opioid formulations.
The petition, which was submitted in April, was undersigned by the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, who fiercely opposed the FDA’s approval last year of the powerful sufentanil product, Dsuvia.
In declining the petition, the FDA stated that, while it was committed to scutinizing how it applies its benefit-risk framework to candidate opioids, it was also legally bound to continue to apply the existing statutory and regulatory framework to properly filed NDAs, including those for new opioid drug products or new opioid formulations.
Further, the FDA expressed the opinion that “a moratorium on the approval of new opioid products could stifle the development and availability to patients of new opioids that could offer greater safety or other therapeutic advantages over products already on the market.”
The FDA will be holding a public hearing on September 17 in which one of the topics to be discussed is whether new incentives are needed to better support and encourage development of such products.
https://www.citizen.org/wp-content/...&eId=9a19a820-0e50-4d80-8ff5-2daaa9b5dc13
https://www.raps.org/news-and-artic...ic-citizen-fda-advisor-call-for-moratorium-on
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