FARE Celebrates Three Food Allergy Wins as Part of Omnibus Spending Law
Increases Food Allergy Research by $3 Million, Allocates $2 Million for Food Allergic School Children Provides FDA with the Authority to Extend Expiration Date for Epinephrine
January 10, 2023 (McLean, VA) – FARE (Food Allergy Research & Education) thanks President Biden and Congress for its efforts to support the more than 32 million Americans with life-threatening food allergies with the recent signing of the Omnibus Spending Bill on December 29, 2022 that included three specific provisions to improve the quality of life for the food allergic community including a 33% increase in food allergy research funding, continuing to protect food allergic children at school, and providing the FDA with the authority to extend the expiration date on critical medicine like epinephrine.
For the second time in less than ten months, Congress increased food allergy research spending by $3 million to the National Institute of Allergy and Infectious Diseases (NIAID) CoFAR (Consortium of Food Allergy Research) upping its FY23 total to $12.1 million (or a 33% increase) to “expand its clinical research network to add new centers of excellence in food allergy clinical care and to select such centers from those with proven expertise in food allergy research.”
Over the last ten months (as Congress passed its FY22 spending bill in March of 2022), CoFAR has grown from $6.1 million in annual funding to nearly double that figure, $12.1 million, or a 98.3% increase. Both funding increase requests were included as part of FARE’s annual “Courage at Congress: Advocate for a Cure” legislative fly-ins.
“In less than one calendar year, we have helped nearly double CoFAR’s annual budget,” said Sung Poblete, PhD, RN, CEO of FARE. “The additional funding that it guarantees will be instrumental in the research efforts of our clinical partners and will help save the lives of the individuals with life-threatening food allergies.”
In addition, FARE was able to secure another $2 million for the Centers for Disease Control through its Chronic Disease Prevention and Health Promotion program to continue its work to develop “a school-based effort to address food allergies and reduce potentially fatal anaphylactic reactions.” This $2 million follows an initial $2 million provided to the program back in March of 2022.
During its May 2022 virtual legislative fly-in, FARE and its advocates asked federal lawmakers and staff to support efforts to lower the cost of epinephrine auto-injectors by passing into law either the Senate’s S. 3799, the Prevent Pandemics Act or the House’s H.R. 7669, the Drug Shortage Shelf Life Extension Act which would give the FDA the power to extend the expiration date on certain medicines including epinephrine.
Research from 2017 and 2019 about epinephrine auto-injectors and their expiration dates reached the same conclusion – that these devices were effective under the FDA standard years after their expiration dates had been reached. The 2019 study said, “All of the EAIs analyzed up to 30 months (2.5 years) beyond the labeled expiration date retained at least 90% of the drug content.”
“As a recent NBC News story points out, the rising cost of life-saving epinephrine auto-injectors especially for families and individuals with high-deductible health insurance plans is one of the greatest burdens food allergy families face,” said Jason Linde, Senior Vice President of Government & Community Affairs. “We look forward to working with the FDA to demonstrate the effectiveness of epinephrine auto-injectors in years two and three and hopefully, persuading the FDA to extend the expiration date and lowering the cost of this life-saving medicine.”
To review the funding changes, please visit page 65 in the “Labor-HHS” attachment for the $3 million more for NIAID’s CoFAR, page 35 for the $2 million for CDC’s Chronic Disease Prevention and Health Promotion work. To review the language providing the FDA the authority to change the expiration date for certain medicines, please see the attached “Sec. 2512.”
FARE (Food Allergy Research and Education) is the nation’s leading non-profit engaged in food allergy advocacy as well as the largest private funder of food allergy research. FARE’s innovative education, advocacy and research initiatives transform the future of food allergy through new and improved treatments and prevention strategies, effective policies and legislation, and novel approaches to managing the disease. To learn more, visit: foodallergy.org.