{"id":4962,"date":"2023-08-03T05:00:16","date_gmt":"2023-08-03T05:00:16","guid":{"rendered":"https:\/\/www.floridarehab.com\/?page_id=4962"},"modified":"2025-02-07T12:30:29","modified_gmt":"2025-02-07T12:30:29","slug":"fda-to-continue-accepting-applications-for-new-opioids","status":"publish","type":"blog","link":"https:\/\/www.floridarehab.com\/drugs\/opioids\/fda-to-continue-accepting-applications-for-new-opioids\/","title":{"rendered":"FDA To Continue Accepting Applications For New Opioids"},"content":{"rendered":"\n

The FDA recently issued a memo rejecting a nonprofit advocacy group\u2019s request for a suspension of new opioid drug approvals. Learn more about it here.<\/strong><\/p>\n\n\n\n

On September 6, The Food and Drug Administration (FDA) issued a memo<\/a> rejecting the request<\/a> for a suspension of new opioid drug approvals. The moratorium request was made in March by a nonprofit advocacy group, Public Citizen\u2019s Health Research Group, in response to a 2017 report<\/a> by the National Academies of Sciences, Engineering, and Medicine. This report provided recommendations for addressing the growing opioid crisis by modifying the FDA\u2019s opioid policy. The moratorium request had also received support from the chair of the FDA\u2019s Anesthetic and Analgesic Drug Products Advisory Committee Raeford Brown.<\/p>\n\n\n\n

Reason For Petition For Moratorium<\/h2>\n\n\n\n

The Public Citizen\u2019s petition requested the moratorium (or temporary prohibition) of new opioid drug<\/a> approvals in response to the growing number of opioid-related overdoses and deaths, with the hopes of encouraging changes in the FDA\u2019s drug approval process.<\/p>\n\n\n\n

Their demand came on the heels of the FDA\u2019s approval of a new opioid drug, Dsuvia. Public Citizen argued that the FDA failed to consider Dsuvia\u2019s high potential for abuse and public harm. The group argued that when considering new drugs, the FDA must consider public health considerations, such as the potential for abuse and whether the drug is safe under its labeling guidelines.<\/p>\n\n\n\n

Risks Of Dsuvia<\/h3>\n\n\n\n

Dsuvia, the newly approved opioid drug, is reportedly ten times stronger than fentanyl<\/a> and is approved for use only in a hospital setting. Public Citizen argued that Dsuvia\u2019s FDA approval will endanger public health due to the drug\u2019s risk of overdose and death. Dsuvia\u2019s high potency led to a boxed warning<\/a> about the high risk of misuse and abuse, which can lead to addiction.<\/p>\n\n\n\n

Dsuvia\u2019s side effects also include extreme sleepiness, respiratory depression, coma, and death. The moratorium\u2019s authors believe that the FDA\u2019s approval process for drugs like Dsuvia does not sufficiently analyze abuse potential or include sufficient safeguards to protect the public. The group contends that regulations should be modified to ensure the potential benefits of a drug outweigh the risk to the general public.<\/p>\n\n\n\n

Reasons FDA Rejected Application<\/h2>\n\n\n\n

In its response<\/a> to Public Citizen\u2019s FDA petition, the agency explained its decision to continue accepting new opioid applications while acknowledging the need for change. The FDA\u2019s response memo stressed it is required to follow existing legal and regulatory requirements when analyzing new drug submissions. The FDA also noted that \u201ca moratorium on the approval of new opioid drug 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.\u201d<\/p>\n\n\n\n

Despite its rejection of the petition, the FDA\u2019s opioid policy is receiving a continued examination, and the agency promised additional modifications to help combat the opioid epidemic. Accordingly, the FDA recently issued draft guidance regarding their opioid benefit-risk assessment framework that incorporates public health considerations.<\/p>\n\n\n\n

If you or a loved one is struggling with addiction to opioids, the proper resources can help. Contact The Recovery Village Palm Beach at Baptist Health<\/a> to speak with a team member who can help you explore opioid addiction treatment programs<\/a>. You deserve a healthier future; call today.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

The FDA recently issued a memo rejecting a nonprofit advocacy group\u2019s request for a suspension of new opioid drug approvals. Learn more about it here. On September 6, The Food and Drug Administration (FDA) issued a memo rejecting the request for a suspension of new opioid drug approvals. The moratorium request was made in March by a nonprofit advocacy […]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":3688,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false},"categories":[70],"tags":[49],"class_list":["post-4962","blog","type-blog","status-publish","hentry","category-news","tag-opioids"],"acf":{"written_by":319,"enable_medically_and_up":["Yes"],"medically_reviewed_by":273,"medically_reviewed_content":"This article was reviewed by a medical professional to guarantee the delivery of accurate and up-to- date information. View our research policy.<\/a>","up_to_date":"Last Updated<\/i> - 08\/06\/21<\/b>","page_first_published_date":null,"page_last_edit_date":null,"highlighted_description":"If you or a loved one is struggling with addiction, help is available. Speak with a Recovery Advocate by calling 888-648-0738<\/b><\/a> now.","key_takeaways":"","source":{"source_label":"View Sources","source_content":"