CLN - Federal Insider
The Africa Centres for Disease Control and Prevention (Africa CDC) has declared the outbreak of clade I mpox as a Public Health Emergency of Continental Security. The World Health Organization (WHO) similarly classified it as a Public Health Emergency of International Concern. According to the Department of Health and Human Services, the U.S. government has pledged continued collaboration with African governments, Africa CDC, and WHO to mount a response.
The risk of clade I mpox spreading to the U.S. remains very low, with no known domestic cases, according to the Centers for Disease Control and Prevention (CDC). The U.S. has a strong surveillance system in place and encourages vaccination for individuals at high risk. The CDC has issued updated guidance for clinicians and travelers to the Democratic Republic of the Congo (DRC) and surrounding regions. According to the WHO, the preferred laboratory test for mpox is detection of viral DNA by PCR.
In 2022, the clade II mpox outbreak led to more than 95,000 cases across 115 non-endemic countries. Clade I mpox is more severe, with a higher mortality rate. Data from endemic countries like the Democratic Republic of the Congo (DRC) suggest that while clade I mpox may cause significant health impacts in the region, it is likely to result in lower morbidity and mortality in the United States compared to the DRC.
The DRC is currently facing its highest annual number of suspected mpox cases ever recorded, with the disease spreading to neighboring countries that previously had no reported cases, according to the WHO.
In addition to diagnostics, vaccination is a key element in controlling the outbreak. The U.S. is donating 50,000 doses of the Food and Drug Administration-approved JYNNEOS vaccine to the DRC and is collaborating with international partners to bolster vaccination efforts.
Congress responds to ADLM advocacy on pediatrics, laboratory developed tests
The Association for Diagnostics and Laboratory Medicine (ADLM, formerly AACC) has made progress over the last few months in its campaign to improve pediatric reference intervals (PRIs) and oppose the Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs).
In a significant advocacy effort on PRIs, ADLM led a coalition of 42 professional societies, clinical laboratories, and manufacturers to push for federal funding dedicated to this cause at the Centers for Disease Control and Prevention (CDC). The effort targeted key congressional offices, emphasizing the urgent need for more accurate diagnostic standards for children. On July 10, persistence paid off. The House Appropriations Committee approved the Fiscal Year 2025 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act. The committee's report language explicitly supported the CDC’s work to improve PRIs. The congressional committee’s report language also referenced a 2022 CDC study that revealed significant discrepancies between current PRIs and actual child development, underscoring the need for this research.
This work gained further momentum on August 1 when the Senate passed the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill for 2025. The Senate report mirrored the House's support for enhancing pediatric reference intervals. The Senate report also went a step further by instructing the CDC to include cost estimates for these improvements in the agency’s next budget request.
On the LDT front, the House also advanced on July 10 the Fiscal Year 2025 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act. The accompanying report urged the FDA to halt its final rule on LDTs, which ADLM argues will lead to restricting patient access to critical testing.
While reports from Congress are non-binding, Congress uses them to provide detailed guidance and accountability for federal agencies.