Diagonal Health

Case Study: Food Allergy Legislation and Appropriations for Research

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Diagonal Health
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Prior to joining MITRE in 2019, Jen was chief of staff to the CEO and senior government affairs leader at Food Allergy Research and Education (FARE), a patient advocacy organization for people, like her father, with life-threatening food allergies. She led development of the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, enacted in 2021. 

In 2018, Jen called on the FDA to use authorities in the 21st Century Cures Act to convene the first-ever patient-focused drug development meeting with individuals and families affected by food allergies.  At the time, there were no therapies on the market. This large-scale event, which drew participation from leading pharmaceutical firms, academic researchers, and patient advocacy groups, surfaced mportant insights on the natural history of food allergy and challenges with the only treatment strategy available to patients at the time, which was complete avoidance of the allergy-causing foods. The recommended strategies, published by FARE, laid the groundwork for bringing a host of innovative products to market, including Dupixent, Xolar, and Palforzia.

In 2018, Jen drove FARE’s organizational response to a global shortage of epinephrine auto-injectors, which are the only treatment that can reverse a life-threatening allergic reaction called anaphylaxis.  She led FARE’s engagement with FDA Commissioner.  Her correspondence with the Commissioner recommended that the FDA declare a national shortage, give guidance to schools on expired products, and approve new generic alternatives.  The FDA acted on Jen’s three recommendations.  Jen also advanced FARE’s press strategy, raising visibility on the shortage.  News coverage of the epinephrine shortage garnered an estimated 335 million online views in several publications: CNBC, USA Today, New York Times, Washington Post.

With thousands of rare diseases in the world for which there are no treatments, one of the first and most critical jobs for a patient advocacy organization is to understand:

  • Regulatory role of the FDA (which approves treatments so that they can be sold across state lines)
  • Important role of private sector investors, industry researchers, and clinical trial sponsors. (who finance both early-phase and regulatory-grade studies of new drugs),
  • And the need for services from experts who’ve done all of this before – like Diagonal Health.

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