U.S. Reps. Kevin McCarthy (R-TX) and David Schweikert (R-AZ) sent a letter to both the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) on the development of medicine to combat Valley Fever.
Valley Fever is a fungal infection that can cause fever, chest pain, and coughing. McCarthy and Schweikert are requesting that the FDA hold public workshops to help with the development of Valley Fever drugs and vaccines.
“We were pleased to see in FDA’s October 9, 2019 correspondence regarding the Tropical Disease Priority Review Voucher Program that the FDA is planning on holding a public workshop on the development of therapies to treat Valley Fever, including a discussion on trial designs, endpoints, and patient populations,” they wrote in the letter.
The FDA regularly holds public workshops for researchers, drug developers, and government officials to discuss best practices for getting drugs or vaccines approved for specific diseases. These workshops can help inform FDA’s Guidance for Industry documents, which include recommendations to help drug developers secure FDA approval for their products.
This bill would direct the FDA to hold public workshops on Valley Fever drug and vaccine development and issue a Guidance for Industry document on it.
“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,” they wrote. “Accordingly, we fully support these public workshops and look forward to them being scheduled as soon as possible. Furthermore, we hope that FDA uses these workshops to inform and ultimately initiate a guidance for industry process with respect to Valley Fever diagnostics, drugs, and biologics.”