Medical Bulletin 15/July/2026

• Cyclosporiasis is classified as a nationally notifiable disease, requiring cases to be reported to the CDC to monitor public health trends. • The CDC, in coordination with state and federal regulatory officials, conducts year-round surveillance to identify outbreaks linked to common food sources in the U.S.

• The FDA has introduced a new fast-track program for the approval of biologics, including experimental gene therapies for conditions like sickle cell disease and cancer. • Traditionally, the agency requires a rigorous three-phase trial process involving healthy volunteers, dose-finding studies, and large-scale clinical trials to ensure safety.

• Health news reports are highlighting a current outbreak of cyclosporiasis, a parasitic infection that causes severe diarrhea. • The reports also address the consequences following the expiration of Affordable Care Act (ACA) subsidies and issues involving the FDA CBER acting director.

• Clinicians in southeast Michigan and northern Ohio are reporting a surge of gastrointestinal illnesses caused by the parasite Cyclospora cayetanensi. • The outbreak is characterized by sudden, explosive diarrhea, though the CDC is reportedly lagging in its tracking and response efforts.

• Leading researchers are warning that a recent FDA policy shift may lead to the approval of ineffective medicines. • In February, the FDA announced that drug sponsors could seek approval based on a single clinical trial and confirmatory evidence, departing from a 1960s-era requirement for two clinical studies.

• Scientists have launched the EBO-PEP clinical trial to test an experimental antiviral pill designed to prevent the Bundibugyo strain of Ebola after exposure. • The study is being led by the DRC's National Institute for Biomedical Research (INRB), France's ANRS Emerging Infectious Diseases, and the medical organization ALIMA.

• A public health emergency occurred in May 2026 across the Democratic Republic of the Congo and Uganda due to an outbreak of Bundibugyo virus disease. • The disease, caused by *Orthoebolavirus bundibugyoense*, is characterized by high mortality rates and a lack of understood reservoir ecology.

• Congress has returned from recess to prioritize bipartisan healthcare legislation, specifically targeting prior authorization reform and the expansion of remote patient monitoring. • Key legislative goals include extending Affordable Care Act (ACA) premium tax credits to maintain insurance affordability for millions of Americans.

• The free-market policy group Unleash Prosperity released a report arguing that significant reforms to the FDA could unlock trillions of dollars in economic value. • The report specifically targets the FDA's lengthy approval process, focusing on the excessive years spent proving a drug's efficacy rather than just safety testing.

• The CDC confirmed 843 cases of Cyclospora across 31 states as of July 9, 2026, while a separate, larger outbreak in Michigan has surpassed 1,562 reports. • Health officials have not yet identified a specific food source responsible for the infections, though the outbreak persists through the summer season.

• The CDC, FDA, and local health departments are investigating multistate outbreaks of domestically acquired cyclosporiasis across the U.S. in 2026. • Officials are working to identify the specific food or water sources causing the infections, noting that the actual number of cases is likely higher due to underreporting.