Congenital Syphilis Is Preventable, When We Can Treat It

In late March 2026, a pregnant patient in Gila County, Arizona was diagnosed with syphilis. She had received one injection of benzathine penicillin G, but her stage of disease called for multiple doses, and she could not be reached within 9 days to continue. Treatment had to restart, and the county had no supply.

Officials submitted an emergency request to Pfizer on March 27. Two separate failures followed. The county listed an account number compatible only with the full price of $8,318.28 when it needed 340B pricing. Separately, Pfizer's protocol required reaching a wholesaler within 72 hours, and that wholesaler had run out of the approved lot. By April 7 nothing had arrived. Commentary from a public health official indicated a significant delay in communication, but it is not clear if that communication delay was from Pfizer or the wholesaler. The patient delivered, and her infant needed intravenous penicillin and a workup that could involve spinal taps, blood draws, and x-rays.

STAT reports that even with fast fulfillment the drug likely would not have arrived 30 days before labor, the interval clinicians aim for. That cuts both ways. Prenatal access and follow-up had failed before Pfizer's clock started, and an injection at any point in pregnancy could still have prevented stillbirth and reduced other complications. That is why the National Coalition of STD Directors asked Pfizer in February to donate reserve doses to health departments. Nearly 4 months later, the company was still evaluating. That evaluation is not on the manufacturer alone. Supply chain flows require cooperation from wholesalers and distributors and real-time communication between those points and local health departments - a specific aspect of failure in the Gila County incident.

Winston Tilghman, STD controller for San Diego County, calls congenital syphilis a "never event." Prevention depends on prenatal access, screening, an available drug, and a completed course of treatment. In Gila County, screening worked. But multiple points of failure between screening and treatment were realized.

The Divergence in the Data

Centers for Disease Control and Prevention (CDC) 2024 provisional surveillance reported combined chlamydia, gonorrhea, and syphilis cases down 9%, a third consecutive annual decline. Congenital syphilis rose for the 12th consecutive year to nearly 4,000 cases. Birth certificate data show the same divergence: the maternal syphilis rate climbed 28% between 2022 and 2024, from 280.4 to 357.9 per 100,000 births, and rose 52% among American Indian and Alaska Native mothers.

One Company, One Plant

Benzathine penicillin G is the only recommended treatment for syphilis in pregnancy, and doxycycline is not an option. Bicillin L-A is the only approved formulation in the United States, made at a single King Pharmaceuticals plant in Rochester, Michigan, with no generic competitor. Erin Fox of University of Utah Health notes that most shortages involve drugs that are not very profitable, and that no company is required to make one regardless of how life-saving it is.

CDC reported on April 14 that Pfizer had moved anticipated recovery to the fourth quarter of 2027. The 600,000-unit pediatric syringes carry an estimated October 2027 release, and once current pediatric vial supplies run out, it is unclear when more will be made. The Food and Drug Administration (FDA) authorizes Lentocilin imports from Portugal batch by batch through the Mark Cuban Cost Plus Drug Company.

What fills the gap is Pfizer's emergency medical request process, restricted to confirmed and at-risk congenital syphilis cases. A health department submits a medical request form, Pfizer approves it against a specific lot number, and the department then has 72 hours to place the order with a wholesaler before the approval expires. Three handoffs, three potential points of failure, and results that vary by weeks. Kansas paid for overnight shipping and waited 28 days. Three hospital pharmacies received shipments within 2 business days, though one waited 6 days despite paying for overnight. Pfizer says it fills requests in the order received and ships more than 90% within 5 days once an order enters the system. It is unclear if hospitals receiving faster delivery are acquiring the medication directly from the manufacturer or using a wholesaler or distributing intermediary to facilitate delivery. It is unclear how long various wholesalers or distributors take to respond to requests as the wholesaler in the Gila County incident refused to comment.

Coverage and Fear

Syphilis screening in pregnancy carries a U.S. Preventive Services Task Force "A" grade and must be covered without cost-sharing. That reaches only people who hold a plan. Congress allowed Affordable Care Act (ACA) enhanced premium tax credits to expire at the end of 2025, and by February 2026 2.6 million fewer people held Marketplace coverage. Ohio and Oklahoma each lost more than 32%, and Arizona, Mississippi, and Louisiana each lost more than a fourth. Mississippi's maternal syphilis rate reached 1,016 per 100,000 births in 2023.

Composition matters. Consumers above the 400% federal poverty level subsidy cliff were 7% of 2025 enrollment but 48% of the drop in plan selections. Sign-ups below 150% FPL fell by roughly 441,000, another 37% of the decline. Those breakdowns describe plan selections rather than effectuated coverage. KFF reports that no effectuated enrollment data is publicly available by income, and that the forthcoming release from the Centers for Medicare & Medicaid Services (CMS) will carry aggregate counts only, so the income split does not map cleanly onto the 2.6 million.

A second pressure lands on the same population. Public charge is a determination in immigration law dating to 1882: people applying for lawful permanent residence can be denied if an officer finds them likely to become dependent on government support. The modern standard has been narrow. Guidance issued in 1999 and codified by regulation in 2022 defined a public charge as someone primarily dependent on government for subsistence, shown by cash assistance for income maintenance or long-term institutionalization. Medicaid, the Children's Health Insurance Program (CHIP), nutrition assistance, and housing support did not count.

On September 18, 2026, the Department of Homeland Security's rescission of those regulations takes effect, moving the standard out of regulation and into discretionary guidance. The preamble names Medicaid, CHIP, nutrition assistance, and housing support among the benefits officers may weigh while declining to define the category, and lets officers count benefits received by family members the applicant is legally obligated to support. Medicaid or CHIP covering a U.S. citizen child could count against a parent.

The effect runs through fear rather than denials. Public charge denials averaged 65 per year between 2020 and 2024. DHS estimates its rule will lead 1.3 million people to disenroll or forgo enrollment, and concedes those effects fall predominantly on people not subject to a public charge determination at all. The chill is the policy.

For pregnant people, that fear operates on the pathway that prevents congenital syphilis, because Medicaid pays for the prenatal visit where screening happens. After a draft executive order leaked in 2017, New York Medicaid data showed immigrant mothers delaying prenatal enrollment and making fewer prenatal visits. Medicaid received by pregnant immigrant women would not have counted under the rule that followed.

Mandates Without Support

Researchers examined 16.3 million live births across 33 states and found expanded prenatal screening mandates associated with a 26% increase in maternal syphilis case detection in the first quarter after enactment, fading to a nonsignificant 11% within a year. Averaged across 4 quarters the effect was 19.5%, and it held under sensitivity testing. Mandates find cases. What they do not do is treat them. Medicaid enrollees experience congenital syphilis at 6 times the rate of people with private coverage, and a law requiring a test does nothing about coverage, clinic capacity, or drug supply.

What We Should Be Asking For

Congress should move H.R. 3866, the Maternal and Infant Syphilis Prevention Act, introduced by Representatives Ciscomani and Stansbury in June 2025 and not advanced since. It directs Health and Human Services to issue Medicaid and CHIP guidance within 12 months, including to the Indian Health Service, Tribes, and Urban Indian organizations. Guidance does not buy penicillin. The bill should carry an advance market commitment or federal procurement guarantee for benzathine penicillin G, with a rotating regional stockpile and priority for restoring the pediatric presentation. CDC released $3.2 million in supplemental funding in July for health departments to purchase tests and medications. That buys doses. It does not buy manufacturing capacity.

Pfizer should donate reserve doses to state health departments as the coalition asked in February and facilitate, where possible, real-time fulfillment agreements with distributing partners. Alternatively, flexible lot allocation and retroactive reconciliation of the drug may help distributing partners better navigate any pre-existing restraints in a more timely fashion. Federal appropriations should allocate incentives to meet the need and expand manufacturing capacity.

Jeffrey Klausner of the Keck School of Medicine has laid out what states can do now: hard-stop order sets in electronic health records, same-day injectable penicillin at any site that tests, expanded authority for trained nurses and pharmacists, rapid point-of-care testing in emergency departments and correctional settings, and a sentinel event review for every case. States should add presumptive Medicaid eligibility in pregnancy, because approval can take months and some prenatal clinics will not see patients until coverage clears. Before September 18, Ryan White case managers and benefits navigators should consider building referral pathways to immigration attorneys.

CDC has set a target of 4.6 primary and secondary syphilis cases per 100,000 women aged 15 to 44 by 2030. That target could be reachable. It is harder to reach while the only approved treatment carries no recovery date before late 2027, while coverage contracts fastest in states already carrying a heavy burden, and while seeking prenatal care carries an immigration risk. Syphilis also raises the risk of acquiring HIV. A meta-analysis of 22 studies covering 65,232 participants found HIV incidence roughly tripled after syphilis exposure among high-risk populations, leading its authors to conclude that prompt diagnosis and timely treatment would be a worthwhile investment for reducing HIV incidence. What we build here we also build for Ending the HIV Epidemic. Nearly 4,000 infants in 2024 were born to parents who needed a blood test and one of the oldest antibiotics in medicine. We have the tools.