Duarte, Costa, Valadao urge FDA to tackle Valley Fever

Valley Congressmembers urge the U.S. Food and Drug Administration to implement preventative research for the disease

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Darren Fraser
Published March 8, 2024  • 
11:00 am

CENTRAL VALLEY – Three Valley U.S. Congress Members have asked the United States Food and Drug Administration (FDA) to add coccidioidomycosis – Valley Fever – to the department’s list of Priority Review Voucher (PRV), which would lead to a fast track for developing treatments and preventative measures for the disease.

In 2020, the FDA determined that Valley Fever did not qualify for PRV. The FDA’s reasoning was that Valley Fever was not eligible for PRV consideration “because of the potential market for preventative products (such as vaccines), and therefore declines to designate it as an addition to the list of tropical diseases.”

The FDA’s PRV selection process also includes a provision that to be considered an eligible disease, the disease must disproportionately impact marginalized populations, according to the Centers for Disease Control and Prevention (CDC) and other public organizations.

On March 6, Congressmembers John Duarte, Jim Costa, David Valadao, David Schweikert, Michelle Steele and Juan Ciscomani submitted a letter to FDA Commissioner Robert Califf. In their letter, the Congressmembers wrote “Valley Fever is an infectious disease caused by the fungus ‘Coccidioides.’ The fungal infection can be severe or deadly, with approximately 200 deaths occurring each year.”

“Valley Fever is a public health threat and it’s vital that we invest in finding effective treatments and preventative measures for it,” Duarte said via a press release. “By obtaining this designation, we can expedite research efforts into the disease and protect thousands of Californians, including my constituents in the Valley.”

According to the latest statistics from the California Department of Public Health (CDPH), in 2020, Fresno County recorded 449 cases of Valley Fever. In 2021, there were 410 cases reported and in 2022, there were 448.

Tulare County recorded 309 cases of Valley Fever in 2020. The numbers remained nearly the same for 2021 and 2022 – 317 and 312, respectively. According to Public Information Officer Carrie Monteith, in 2023 the County recorded 466 cases. But Monteith cautioned these numbers are provisional counts submitted by CDPH.

Individuals contract the disease by inhaling dust that contains Coccidioides fungus spores. The fungal spores are disturbed and become active when dirt is disturbed by digging – not unlike what farmers do every day.

The letter stated that in 2019 – the year the CDC has the most up-to-date information – there were over 20,000 cases of Valley Fever. The letter did not specify if the cases were from the Valley.

The other FDA criteria for qualifying a disease as PRV worthy is it disproportionately impacts marginalized populations – which is government speak for poorer communities.

While it is true agricultural workers in Fresno and Tulare counties have made advances economically as of late, all the prevailing data indicates these workers remain in the class of economically marginalized populations.

According to the Federal Register, Vol. 85, No. 136, dated July 15, 2020, the U.S. Food and Drug Administration (FDA) determined Valley Fever does not present a significant health concern, despite the following:

  • The fungus occurs in hot, dry climates;
  • Acute coccidioidomycosis presents with fever, muscle pain, cough, rash, weight and malaise; and
  • Five to 10% of affected patients develop lung disease, such as cavitary pneumonia, nodules and bronchiectasis.

There are a myriad of other diseases associated with Valley Fever.

The purport of the letter to the FDA was to impress upon the agency the urgency of developing treatments and/or vaccinations for Valley Fever. According to the CDC, there are no vaccines for preventing Valley Fever despite the fact scientists have been trying to create a vaccine since 1960. 

According to the Federal Register document, there are two FDA-approved treatments for Valley Fever. Amphotericin B deoxycholate and ketoconazole. But in 2013, the FDA warned that ketoconazole should not be used as a first-line therapy as it can cause severe liver injury, adrenal insufficiency and may cause harmful drug interactions.

The California Department of Health reported 317 cases of Valley Fever in Tulare County in 2021. The Department noted that hotspots for the diseases included digging and new construction.

Darren Fraser
Reporter