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The preferred antibiotic treatment for syphilis is in short supply across the United States as infections soar, and more than three dozen leading public health groups are urging the White House to intervene.
The National Coalition of STD Directors and 38 other public health groups sent a letter to members of the White House Drug Shortage Task Force on Monday that detailed how clinics are reporting trouble placing orders for the go-to syphilis drug Bicillin — a long-acting injectable form of the antibiotic penicillin — and those that have been able to place orders are receiving only partially filled or delayed orders.
The letter calls for the White House task force to take up the Bicillin shortfall as a priority and work with drugmaker Pfizer to ensure adequate supply.
“Bicillin L-A remains the preferred treatment for primary and secondary syphilis in adults, infants, and children, and the only approved treatment for syphilis in pregnant women,” according to the letter.
“As the only manufacturer of penicillin G benzathine in the United States, Pfizer’s inability to provide adequate quantities of Bicillin L-A has left the Food and Drug Administration, the Centers for Disease Control and Prevention, and many local and state health departments scrambling to ration existing supply of the drug and develop contingency plans,” says the letter, signed by organizations involved in public health, HIV and maternal health.
“Affected communities and key stakeholders need to know the exact causes of the current shortage, including how Pfizer plans to fix this situation quickly and prevent it from happening again. Investments in shortage prevention efforts must be prioritized and we hope the company is already making progress toward resolving the Bicillin L-A shortage sooner than stated. But, we require support from the Drug Shortage Task Force to ensure accountability.”
The National Coalition of STD Directors confirmed to CNN on Tuesday that it has not received a reply from the White House or the task force.
A White House spokesperson said in a statement that the Biden-Harris administration “remains focused on strengthening the resilience of critical supply chains, including for medical products like pharmaceuticals. President Biden has issued five executive orders to catalyze whole-of-government action toward these objectives. This work to strengthen pharmaceutical supply chains is a continuation of the work that began on Day 1 of President Biden’s Administration to ensure Americans can access the medicine they need when they need it.”
Pfizer said in an email it is in constant communication with the CDC and FDA about its supply of Bicillin and has increased its output by about 30% more product this year, with a goal to double output by the end of next year. That ramp-up will take some time to be felt in the market, according to the company.
The letter that was sent to the White House this week describes how a 2017 shortage of Bicillin “coincided with a significant increase in congenital syphilis cases that has dramatically worsened ever since.”
The United States is facing a rise in syphilis cases. From 2017 to 2021, reported cases of syphilis increased about 74%, and congenital syphilis — when a mother passes the infection to her baby during pregnancy — increased more than 203%, according to data from the CDC. In 2021, cases of congenital syphilis were reported in nearly every state and surged to a more than 27-year high.
“It’s devastating to see the dramatic rise in completely preventable congenital syphilis cases while clinics can’t get their hands on the basic antibiotic they need to save lives and prevent profound consequences for newborn babies,” David C. Harvey, executive director of the National Coalition of STD Directors, said in a news release Monday. “The government must launch a response to the syphilis epidemic that guarantees clinics can get the Bicillin L-A they need right now and prevents the repeated shortages like this one from ever happening again.”
Pfizer acknowledged limited supplies of Bicillin in June and at the time estimated that the issue may not be resolved until 2024.
The company sent a letter to clinicians that month, which was posted online by the FDA, stating that the “supply interruption” impacting Bicillin “is the result of a complex combination of factors including significant increases in demand, due to an increase in syphilis infection rates as well as competitive shortages. In order to meet this increased demand, Pfizer has prioritized manufacturing capacity.”
In the months after that announcement, many state health department, including in California, Louisiana, Minnesota, Pennsylvania, Texas and Virginia, issued health advisories on the shortage and recommendations for alternative treatment options for syphilis patients.
CNN’s Betsy Klein contributed to this report.
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