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National Coalition Letter Urges White House Task Force Intervention on Syphilis Drug Shortage
Thirty-nine leading public health groups urge stronger action on repeated shortages of Pfizer's Bicillin L-A
October 2, 2023
National Coalition Letter Urges White House Task Force Intervention on Syphilis Drug Shortage
For Immediate Release: October 2, 2023 Contact: Elizabeth Finley, email@example.com, 919-749-7309
Washington, D.C. — On Monday, a coalition of 39 leading public health groups sent a letter urging the White House Drug Shortage Task Force to prioritize action to end the ongoing shortage of Bicillin L-A. Bicillin L-A is the only approved treatment for syphilis in pregnant women and the preferred treatment for syphilis in adults, infants, and children. Clinics and states have reported being unable to access Bicillin L-A, and Pfizer – the drug’s exclusive manufacturer – has reported that they will not resolve the shortage until mid 2024.
“The Bicillin-LA shortage is not just another drug shortage. It is the latest in a long pattern of syphilis treatment disruption that we’ve seen in America for decades.” says Jeremiah Johnson, Executive Director of PrEP4All. “Following Pfizer’s previous failure to ensure uninterrupted supply, we saw an enormous increase in the number of congenital syphilis cases in the US; we need the government to step in and do whatever it takes to make sure that we don’t just see ourselves with the same mess 3 or 4 years down the road.”
The CDC’s most recent data shows a 203% increase in congenital syphilis in the five-year period between 2017 and 2021. Congenital syphilis is completely preventable when a pregnant woman receives an injection of Bicillin L-A. If left untreated with Bicillin L-A, syphilis can cause stillbirth or significant birth defects.
“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,” says David C. Harvey, executive director of the National Coalition of STD Directors. “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”
The letter to the White House Drug Task Force is signed by 39 of the nation’s leading public health, HIV, and maternal health organizations.
Drug Shortage Task Force
1600 Pennsylvania Avenue NW
Washington, DC 20500
Members of the White House Drug Shortage Task Force,
The undersigned 39 organizations urge the White House Drug Shortage Task Force to take up the penicillin G benzathine (Bicillin L-A) shortage as a priority and work with the manufacturer to ensure adequate supply in the United States. 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. 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.
Only a few months into the shortage, clinics are already reporting that they have been unable to place orders for Bicillin L-A, and those that have been able to place orders are reporting that they are only partially filled or delayed. This is forcing providers to borrow supply from nearby clinics and refer patients elsewhere for care, which delays treatment.1
Pfizer first reported a manufacturing delay in June of this year, reporting that the shortage will likely continue through 2024. Given the unreliability of Pfizer’s timeline and its vague explanations of why the shortage has occurred, key stakeholders are worried the situation will deteriorate further.
Shortages of Bicillin L-A have been a recurring concern in the US in recent years. In 2002 Wyeth-Ayerst, the previous manufacturer of Bicillin L-A, created shortages in North America when it halted production of the product at a Canadian plant. In 2005, shortages reoccurred and persisted for nearly five years.2
Most notably, advocates sent a nearly identical sign on letter to Pfizer in 2017 as part of a two-year shortage that coincided with a significant increase in congenital syphilis cases that has dramatically worsened ever since. Congenital syphilis–syphilis in newborns acquired during pregnancy–is an entirely preventable, yet dangerous disease; it may result in stillbirth or infant death in up to 40% of cases and includes long-term health consequences such as low birth weight, deformed bones, blood and organ abnormalities, blindness, and deafness. In 2015, there were a total of 494 reported cases of congenital syphilis, for a national rate of 12.4 cases per 100,000 live births. Following Pfizer’s shortage, the number leapt to 941 cases in 2017 (rate: 24.4 per 100,000 live births), 1,313 cases in 2018 (rate: 34.6 per 100,000 live births), and an astounding 1,875 cases in 2019 (rate: 50.0 per 100,000 live births).3 As we head into yet another shortage, it is imperative that Pfizer not only invest significant resources to address the manufacturing problems, but be forthcoming with all stakeholders impacted by the shortage regarding the reason(s) for the delay. Given that the company’s 2017 plans to avoid future shortages have failed, we are also eager to learn more about what the company plans to do differently to safeguard against additional shortages.
We are also highly skeptical of the company’s attempts to primarily blame the shortage on increasing demand, which appears to unfairly deflect blame to communities affected by syphilis. However, trends in syphilis rates are clear and demand has been and will continue to increase for the foreseeable future; if Pfizer was truly caught completely off guard, it raises significant questions about the competency of the company to forecast obvious infectious disease trends. According to the CDC, the rate of primary and secondary syphilis has increased almost every year since 2000, increasing 28.6% between 2020 and 2021.4 Rates have increased among both males and females, in all regions of the United States, in all age groups. and in all racial and ethnicity groups. Gay and bisexual men made up almost half (46.5%) of all P&S cases among men in 2021.
Additionally, we are concerned about how the shortage may impact 340B and commercial supply differently, and we ask for your help in working with Pfizer to ascertain whether the 340B stock of Bicillin L-A is more severely impacted and if so, how Pfizer intends to alleviate the strain on safety-net providers that rely on the 340B program to access this expensive medication.
Because Bicillin L-A is the only approved syphilis treatment for pregnant women, they remain an extremely vulnerable population when shortages occur. While alternative regimens for primary and secondary syphilis infections are possible in other populations, treatment becomes more complicated—with patients having to adhere to multiple daily doses over two weeks—and inferior to the penicillin G benzathine standard of care, particularly from a public health perspective.
The syphilis epidemic has already proven challenging to control. If affected communities and public health officials in the United States must rely on a single manufacturer for the standard of care, that manufacturer must be able to maintain adequate supply. Unexplained and repeated manufacturing delays not only endanger the successful treatment of syphilis, they endanger efforts to cure people in a timely manner, stop onward transmission, and bring down rising levels of new infection rates.
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.
NCSD can be reached by emailing Rachel Deitch at firstname.lastname@example.org and PrEP4All can be reached by emailing Jeremiah Johnson at Jeremiah@PrEP4All.org. At a minimum we request that the Bicillin L-A shortage be taken on as a priority of the task force, that members of the task force meet with us to discuss additional opportunities for next steps, and that you work with Pfizer to share prompt, transparent communication about the shortage with affected communities. We must rectify this unacceptable situation and prevent future recurrences.
AccessHealth MA (formerly Community Research Initiative) Act Now: End AIDS (ANEA) Coalition AIDS Action Baltimore
AIDS Alabama AIDS Cure Research Collaborative AIDS Foundation Chicago AIDS Treatment Activists Coalition (ATAC) AIDS United Allentown Health Bureau American College of Nurse-Midwives amfAR Association of Maternal & Child Health Programs AVAC Big Cities Health Coalition Center on Halsted Desert Oasis Healthcare Equality California Five Horizons Health Services HealthHIV HIV+Aging Research Project-Palm Springs ICHANGE Jacobs Institute of Women’s Health LKA Palm Springs NASTAD National Coalition for LGBTQ Health National Coalition of STD Directors National Family Planning & Reproductive Health AssociationNational PrEP Program – PrEP4ALL National Working Positive Coalition NMAC Palmtree Clinical Research, Inc. Prevention Access Campaign Renegade.bio San Francisco AIDS Foundation The AIDS Institute Treatment Action Group U=U plus Valley AIDS Council West Virginia Department of Health
1 National Coalition of STD Directors, “NCSD Releases First Known Survey of the Bicillin L-A Shortage Impact on Clinics.” 15 Sep. 2023. https://www.ncsddc.org/wp-content/uploads/2023/09/NCSD-First-Bicillin-Survey-Results-9.13.23.pdf
2 Wyber R, et al. Benzathine Penicillin G for the Management of RHD: Concerns About Quality and Access, and Opportunities for Intervention and Improvement. Glob Heart. 2013 Sep;8(3):227-34. doi:10.1016/j.gheart.2013.08.011.
3 “Congenital Syphilis, 2017-2020.” Centers for Disease Control and Prevention NCHHSTP AtlasPlus. https://www.cdc.gov/nchhstp/atlas/index.htm. Accessed July 5, 2023.
4 “Sexually Transmitted Disease Surveillance 2021: National Overview of STDs.” Centers for Disease Control and Prevention. https://www.cdc.gov/std/statistics/2021/overview.htm. Accessed July 5, 2023.