FDA Approves Temporary Importation of Syphilis Drug Amidst Ongoing Treatment Shortage

The temporary importation of a syphilis drug from Paris-based company Laboratoires Delbert was approved by the US Food and Drug Administration in response to the ongoing drug shortage in the United States, reports HealthDay News.¹  

The shortage of Pfizer’s Bicillin syphilis medication in the US since mid-2023 put pregnant women and their families at risk for health complications due to untreated syphilis. Data from the US Centers for Disease Control and Prevention report that syphilis cases jumped about 74% between 2017 and 2021, while cases of syphilis in newborns increased more than 203%.   

Laboratoires Delbert confirmed plans to temporarily import 3.5 million units of Extencilline² in a letter following the FDA’s approval on January 11, 2024. Extencilline, while not previously an approved treatment in the US, is a long-acting injectable form of penicillin for adults and pregnant women like Bicillin.  

The Biden administration was urged in October 2023 by dozens of public health groups including the National Coalition of STD Directors to address the Bicillin shortage as syphilis cases jumped across the country, CNN reported.³ 

“The delays in treatment that women have faced because of the shortage has placed them and their families at grave risk during the nation’s syphilis crisis,” executive director David Harvey of the National Coalition of STD Directors said in a statement.³ “Today, the administration took meaningful action on our ongoing ask they do anything and everything in their power to address the Bicillin L-A shortage and to provide communities with the resources they need to treat patients and solve this public health crisis." 

The Bicillin supply issue is predicted to ease in the second quarter of 2024 according to the FDA’s drug shortages database.⁴ 

References 

1. Foster R. FDA to import syphilis drug from France amid shortage. HealthDay. January 11, 2024. Accessed January 12, 2024. https://www.usnews.com/news/health-news/articles/2024-01-11/fda-to-import-syphilis-drug-from-france-amid-shortage 
2. Laboratoires DELBERT. Temporary Importation of Extencilline, (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units with Foreign, non-U.S. Labeling to Address Supply Shortage. Accessed January 12, 2024. https://www.fda.gov/media0/175366/download  
3. Dillinger K. FDA to allow importation of syphilis drug amid ongoing shortages. CNN. January 10, 2024.  Accessed January 12, 2024. https://www.cnn.com/2024/01/10/health/fda-syphilis-drug/index.html  
4. FDA Drug Shortages. US Food and Drug Administration. April 26, 2023. Accessed January 12, 2024. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Penicillin%20G%20Benzathine%20Injection&st=c#