FORWARD Act of 2019

Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 or the FORWARD Act of 2019

This bill establishes programs to support the research of endemic fungal diseases and the development of antifungal drugs. (Endemic fungal diseases are fungal infections, e.g., Valley fever, that tend to to occur in specific geographic areas and affect particular at-risk populations, e.g., older adults.)

Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' (HHS) efforts to address endemic fungal diseases. The working group is comprised of experts from both relevant federal agencies and the private sector. The bill requires HHS to award grants for fungal disease research to local hospitals, higher education institutions, public health agencies, and nonprofit organizations. HHS also must establish an accelerated research program modeled after its research program to combat antibiotic resistant bacteria.

The bill further requires the National Institutes of Health to develop a publicly-accessible server using blockchain technology to securely facilitate the sharing of fungal disease clinical research data. (Blockchain technology uses cryptography to create a digital ledger of transactions that can be simultaneously used and shared within a large, decentralized, and permanent network.)

Additionally, the Food and Drug Administration (FDA) must prioritize the review of drugs to treat endemic fungal diseases and fast track the approval of such drugs at the request of applicants. The FDA must issue draft and final guidance related to the approval of antifungal products and therapies, including those that diagnose, treat, or prevent Valley fever.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov