McCarthy urges FDA to hold public workshops addressing vaccine for Valley Fever

U.S. Rep. Kevin McCarthy (R-CA) last week requested that the U.S. Food and Drug Administration (FDA) hold public workshops on the development of diagnostics, drugs and biologics for Valley Fever, a fungal disease that can be life-threatening.

“While the scientific community has made important advances in recent years, treatments are limited and there is currently no FDA-approved cure or vaccine,” wrote Rep. McCarthy in a Feb. 14 letter sent to federal health administration officials that also was signed by U.S. Rep. David Schweikert (R-AZ).

According to the lawmakers’ letter, Valley Fever, clinically known as Coccidioidomycosis, is caused by inhaling the spores of a fungus found in the soil in the American Southwest and Pacific Northwest, where their home states are located.

Rep. McCarthy and his colleague also noted in their letter that a bipartisan bill they’ve introduced would direct the FDA to hold such public workshops, which can help inform FDA’s Guidance for Industry documents that contain non-binding recommendations to help drug developers secure FDA approval for their products.

“It is our belief that increased collaboration through public workshops, as well as the FDA issuing a guidance for industry document, will be an important step to facilitate the development of novel therapies and a vaccine for Valley Fever,” wrote Rep. McCarthy and his colleague. “Accordingly, we fully support these public workshops and look forward to them being scheduled as soon as possible.”

Rep. McCarthy in May 2019 sponsored the Finding Orphan-disease Remedies With Antifungal Research and Development (FORWARD) Act of 2019, H.R. 2858, with Rep. Schweikert signing on as the lead original cosponsor and U.S. Rep. Karen Bass (D-CA) among the other 10 cosponsors.

If enacted, H.R. 2858 would support endemic fungal disease research, incentivize fungal vaccine development, and discovery of new antifungal therapies and diagnostics, according to the text of the bill.

The bill remains under consideration in the U.S. Energy and Commerce Subcommittee on Health.