FDA Acts on Congressional Valley Fever Task Force Request
Washington, DC - Chairman of the Congressional Valley Fever Task Force, Rep. Kevin McCarthy (CA-23) and Co-Chairman, Rep. David Schweikert (AZ-06) released the following statement on the Food and Drug Administration's (FDA) decision to include the Coccidioides species, known to cause what is commonly referred to as Valley Fever, on a list of Qualifying Pathogens it developed as required by the Generating Antibiotic Incentives Now (GAIN) provisions of Public Law 112-144:
"The decision by the Food and Drug Administration to add the underlying fungi species responsible for Valley Fever to the list of qualifying pathogens is big win for our constituents suffering from this disease. FDA's actions will help with developing an effective treatment and vaccine for this disease. The Congressional Valley Fever Task Force has been working with stakeholders to raise awareness for what is a relatively unknown disease nationally but is prevalent in our communities.
"Through events such as the Valley Fever Symposium in California and the Valley Fever Open House in Arizona, we were able to have leading Valley Fever experts, Centers for Disease Control and Prevention and National Institutes of Health scientists, community health leaders, and those directly affected by Valley Fever come together to discuss what steps can be taken to set us on a path to finding a vaccine and cure for Valley Fever.
"The recent FDA announcement is an important step that will create incentives to promote a Valley Fever treatment and vaccine and expedite the regulatory approval process. We remain committed to working with our constituents, medical professionals, and Valley Fever experts on a treatment and vaccine for this disease to ensure that those most vulnerable to it are no longer inhibited by its effects. We are thankful for all who participated in the public comment process to get the fight against Valley Fever to this point."
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Background:
In March 2013, the Centers for Disease Control and Prevention released a report detailing a significant increase in Valley Fever incidences between 1998 and 2011 and that calls for additional research into Valley Fever prevention and treatment. On July 31, 2013, Congressional Valley Fever Task Force Chairman Kevin McCarthy, Co-Chairman David Schweikert, and Task Force members Reps. Ron Barber, Ken Calvert, Michael Conaway, Paul Cook, Jim Costa, Doug LaMalfa, Buck McKeon, David Valadao, and Juan Vargas sent a letter to FDA Commissioner Margaret Hamburg requesting that the fungal pathogens that cause coccidioidomycosis, commonly referred to as Valley Fever, be included on the list of Qualifying Pathogens that FDA was developing as required by Public Law 112-144. By including Coccidioides on this list, FDA will give priority and expedited review to Valley Fever treatment and vaccine drug applications, as well as extend for 5 years the marketing exclusivity period for these products. These incentives will help promote the development of drugs to prevent or cure Valley Fever, which is prevalent across the American Southwest.