Proposed language is the first action from Congress to directly confront repeated shortages
FOR IMMEDIATE RELEASE: July 12, 2024
Contact: Elizabeth Finley, efinley@ncsddc.org, (919) 749-7309
Washington, DC – On Thursday, the Senate released its FY’25 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations, revealing new language to address repeated shortages of Bicillin L-A, the only treatment available to prevent congenital syphilis. Bicillin L-A has been in shortage since Spring of 2023. The language in the bill directs leaders of the FDA, HHS, and CDC to provide the Committee with a plan to ensure an adequate supply of Bicillin L-A and prevent future shortages. The proposal also calls on federal agencies to coordinate with the drug’s manufacturer to ensure that drug production plans are based on current syphilis data. David C. Harvey, Executive Director of NCSD, issued the following statement on behalf of the National Coalition of STD Directors:
“We applaud the Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Subcommittee for directly addressing the role drug shortages play in the dire and tragic syphilis crisis in America. It is unacceptable that pregnant women have been denied immediate treatment for syphilis because their doctors can’t get the basic antibiotics they need to protect their babies. The report language is a major step forward and the first action we’ve seen from Congress to prevent these repeated, deadly shortages from ever happening again. We urge Congress to include this language in the final FY’25 appropriations package to make sure pregnant patients and their babies get these essential drugs they need,” said David C. Harvey, Executive Director of NCSD.
Background: 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. In June of 2023, Pfizer alerted the FDA to a shortage of Bicillin L-A. The shortage left providers unable to acquire necessary treatments and only started to ease in Summer 2024. In response to the shortage, CDC 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. 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 and 2024 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.
###