McCarthy, Schweikert Request FDA Action on Valley Fever Drug and Vaccine Development
Today, Congressman Kevin McCarthy and Congressman David Schweikert (AZ-06) sent a letter to the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) requesting the FDA hold public workshops to help with the development of Valley Fever drugs and vaccines.
Highlights of the letter are below, or you can read it here.
“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.
“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. 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."
- The FDA routinely holds public workshops that bring together researchers, drug developers and government officials to discuss best practices for getting drugs or vaccines approved for specific diseases.
- These public workshops can help inform FDA’s Guidance for Industry documents, which contain non-binding recommendations to help drug developers secure FDA approval for their products.
- Section 4 of Congressmen McCarthy and Schweikert’s bill (H.R. 2858) would direct the FDA to hold public workshops on Valley Fever drug and vaccine development and issue a Guidance for Industry document to help with the development of such products.