adequate supply. The only manufacturer of penicillin G benzathine in the US, Pfizer, first reported a manufacturing delay in June and reports the shortage will likely continue through 2024.

The letter expresses concerns about how the shortage may impact 340B and commercial supply differently and asks for 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.

The letter expresses skepticism of the company’s explanation that the interruption is due “to an increase in syphilis infection rates as well as competitive shortages.” The letter questions 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.[1] After the Pfizer announcement state health departments issued health advisories on the shortage and recommendations for alternative treatment options for syphilis patients.[2]

[1] “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.

[2] Examples of health advisories:  California, Louisiana, Minnesota, Pennsylvania, Texas and Virginia,

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Action:  Submit comments to support including cervical cancer HPV primary screen in covered preventive services.

Background: The Patient Protection and Affordable Care Act (ACA) of 2010 included a provision that ensures preventive health services will be covered with no out-of-pocket costs. After the Institutes of Medicine drafted the initial recommendations defining which women’s health services are preventive, the U.S. Department of Health and Human Services, Health Resources and Services Administration (HRSA) contracted with the American College of Obstetricians and Gynecologists (ACOG) to develop, review, and update these recommendations for women’s preventive healthcare services.

ACOG’s Women’s Preventive Services Initiative (WPSI) has developed, reviewed, and drafted recommendations for HRSA-sponsored Women’s Preventive Services Guidelines. If adopted by HRSA, the recommendations will help ensure that women receive the recommended preventive services without a co-payment, co-insurance or deductible under all commercial insurance plans except Medicaid/CHIP managed care plans. 

Summary of WPSI Cervical Cancer Draft Recommendation: WPSI recommends “cervical cancer screening for women aged 21 to 29 using cervical cytology (Pap test) every 3 years. Co‐testing with cytology and HPV testing is not recommended for women younger than 30 years. Women aged 30 to 65 should be screened with cytology and HPV testing every 5 years (preferred) or, if HPV testing is not available, cytology alone every 3 years (acceptable). In appropriately counseled women aged 25 and older, Food and Drug Administration (FDA)-approved primary HPV screening tests can be considered as an acceptable alternative to current cytology-based cervical cancer screening methods and should not be excluded from preventive services.”

Suggested Comment: The language in the WPSI recommendation comment in support of primary screen is not strong enough because the ATHENA Study showed that for patients 25 years and up HPV primary screening is better than the Pap test alone in detecting CIN3 or above.  Therefore, the recommendation should read: Co‐testing with cytology and HPV testing is not recommended for women younger than 30 years, however, primary HPV screening test is an acceptable alterative to cytology-based screening methods and should be included in preventive services. 

How to Submit Comments:  To submit comments, visit WSPI’s website[1] before September 30, 11:59 p.m. Pacific Daylight Time. You can comment on, the accuracy and completeness of the recommendation; and how consistent the recommendation is with your organization’s policy. 

[1] www.womenspreventivehealth.org/public-comment/screening-for-cervical-cancer/

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