The Food and Drug Administration (FDA) is responsible for ensuring the efficacy of drugs and the safety of the nation’s food supply, but the agency has a history of failing to address the needs of the allergic community. That legacy continued recently when the FDA succumbed to outside pressure. I’ll explain.
Before I do, here’s a quick review of the FDA’s history regarding food allergies leading up to last week:
- In 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) was enacted, identifying eight top allergens required to be listed on the label when they are ingredients of a product. However, the regulations are ambiguous, allowing for multiple ways of listing those ingredients, and they do not address the issue of potential cross-contact which has led to a spate of unregulated precautionary label warnings like “may contain” that are entirely voluntary. To this day, the food allergy community is still unable to determine whether a product is safe for consumption without calling the manufacturer.
- In 2016, the Food Safety Modernization Act (FSMA) was enacted, raising the prevention of allergen cross-contact to the same level of importance as the prevention of food-borne illnesses. That legislation led manufacturers to add trace amounts of allergens to their food products in order to skirt the more stringent protections of the FSMA, resulting in products that were nominally safe for the allergic community to become dangerous;
- In 2021, the Food Allergy Safety, Treatment, Education & Research Act (FASTER) was enacted, which raised sesame to the ninth top allergen to be included under FALCPA. Having not learned from the debacle caused by the 2016 introduction of the FSMA, the legislation made no provision to prevent manufacturers from adding trace amounts of sesame to their products, which they did in droves. Now, many more products contain sesame than before the legislation was passed.
Recently, the FDA blind-sided the food allergy community by denying approval of what would have been the first needle-free emergency epinephrine device called neffy™. Unlike traditional epinephrine auto-injectors, the device does not rely on a needle and a jab to the thigh to administer the life-saving drug; instead, the drug is administered via nasal spray.
For many, this alternative of a needle-free device — especially for those who fear needles — would have been a boon, shortening the time to administer the drug in an anaphylactic emergency, resulting in better outcomes and saving lives.
ARS Pharmaceuticals — the company behind neffy — fully expected approval of the drug given feedback from the FDA right up until September 19, when it received notice of denial. But to understand the full context of the decision including the politics involved, we need to look back at what had transpired before then.
After completing a multitude of clinical trials where neffy performed on par or better than epinephrine auto-injectors and intramuscular injection, the company submitted their findings and were granted a review by the FDA’s Division of Pulmonology, Allergy and Critical Care Advisory Committee on May 11, 2023.
That 22-member committee voted in favor to approve neffy 16:6 for use in adults and 17:5 for use in children. While the FDA is not bound to follow the directions of their advisory committees, they usually do.
Since then, the agency has been working with ARS to finalize preparations for approval down to hammering out the finer details of package labeling. At no time did the agency provide any indication that more testing was necessary.
On Monday, June 12, a company called Viatris — the parent of subsidiary Mylan that markets EpiPen® — submitted a 28-page citizen petition to the FDA requesting the agency delay approval until additional testing is performed.
It should be noted that Viatris — whose EpiPen holds the lion’s share of the epinephrine auto-injector market — would stand to lose hundreds of millions of dollars if a needle-free competitor were to gain approval.
Viatris demanded repeat dosing tests in individuals with rhinorrhea (runny nose):
Data from study designs that do not include rhinorrhea subgroup analyses provide only some of the evidence necessary to evaluate the efficacy and safety of ARS-1 for anaphylaxis. Such studies leave open key uncertainties regarding the potential real-world performance of ARS-1 across individuals experiencing a range of vasodilatory effects in the nasal mucosa during anaphylaxis.— Viatris Citizen Petition
This is nonsense as ARS already showed neffy to be effective in test subjects with rhinorrhea — where it proved to be absorbed even better with a runny nose than without — and in repeat dosing studies.
Adding further context, the FDA had already determined a study of this type was NOT required for neffy to gain approval by agreeing with the company to complete this type of test post-approval.
So, despite all indications otherwise, why did the FDA ultimately deny approval of neffy? And if they had determined this testing was indeed necessary for approval, why did they wait until mid-September to notify ARS instead of back in June?
It is our belief the FDA bowed to corporate pressure as they have in the past, this time kowtowing to the demands of big pharma rather than approving an important tool in the fight against anaphylaxis.
Given the checkered history of the FDA, we cannot assume the agency will act in our best interest even when further tests of neffy are completed, so we must take action if we truly want to have needle-free options approved in the future.
If you haven’t yet signed our petition, please do so here and be sure to share it with family, friends, co-workers, and on social media. Then please contact your senators [find yours here] and your congressperson [find yours here] and let them know that lives depend on the availability of nasal epinephrine and that you demand action now.
Please do your part by spreading the word: Contact your local media and become the champion of the effort to bring nasal epinephrine to a community desperately in need of an alternative.