Policy Statement, Press Release
NCSD Applauds FDA’s Temporary Approval to Import Crucial Congenital Syphilis Drug Amid National Shortage
Continued efforts are needed to fully resolve the shortage and prevent future shortages
NCSD Applauds FDA’s Temporary Approval to Import Crucial Congenital Syphilis Drug Amid National Shortage
Continued efforts are needed to fully resolve the shortage and prevent future shortages
FOR IMMEDIATE RELEASE: January 10, 2024
Contact: Elizabeth Finley, efinley@ncsddc.org, (919) 749-7309
Washington, DC – On Wednesday, the Food and Drug Administration announced temporary approval for the importation of Extencilline, the same antibiotic as Bicillin L-A available outside of the U.S. Benzathine penicillin g – exclusively manufactured and marketed by Pfizer as Bicillin L-A in the U.S. but available from other manufacturers internationally – is the only drug that can be used to treat syphilis in pregnant people and is an essential medicine for stopping the rapid rise in congenital syphilis cases in the U.S. David C. Harvey, Executive Director of NCSD, issued the following statement:
“We applaud the FDA, HHS, and Admiral Levine for taking this important step to protect pregnant people and babies by ensuring U.S. healthcare providers have the essential medicine they need to treat and prevent congenital syphilis. 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.”
“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. We hope this is the first step toward seeing a resolution to this shortage, and that HHS and FDA will continue to take steps to ensure that communities never experience a syphilis treatment shortage again,” said David C. Harvey, executive director of NCSD.
About the Bicillin L-A Shortage
Bicillin L-A is the only treatment available for pregnant people with syphilis and is an essential drug for preventing congenital syphilis; Bicillin L-A is also the first line of treatment for all syphilis patients. Pfizer is the only manufacturer that provides benzathing penicillin g to the U.S. market under the name Bicillin, however other manufacturers manufacture and sell the drug in other countries. In June of 2023, Pfizer alerted the FDA to a shortage of Bicillin L-A and predicts the shortage continuing into Q2 of 2024. In response to the shortage, CDC has asked providers to prioritize treating pregnant patients with syphilis with Bicillin L-A and using doxycycline for other patients. While doxycycline is an effective drug for syphilis, patients can struggle to complete doxycycline treatment, leaving their syphilis untreated and risking continued community transmission.
Background: Congenital Syphilis
Congenital syphilis is a syphilis infection that is passed from a pregnant person who has syphilis to the fetus during pregnancy. Congenital syphilis can cause stillbirth and infant death or result in lifelong disabilities. Congenital syphilis is preventable with timely testing and treatment with the antibiotic Bicillin L-A. New congenital syphilis data from 2022, shows that case numbers have increased ten-fold over the past decade. The congenital syphilis crisis has been further exacerbated in 2023 by a shortage of Bicillin L-A, the only antibiotic that can safely treat pregnant people with syphilis, and by cuts to the STD workforce.
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