Manhattan firm's "allergy drops" prompt CBER untitled letter

Regulatory NewsRegulatory News | 06 April 2021 |  By 

The US Food and Drug Administration’s (FDA’s) biologics division has delivered an untitled letter to a Manhattan-based firm for marketing sublingual “allergy drops” from its Fifth Avenue address.
Curex, Inc. was the recipient of the missive sent 23 March by the Office of Compliance and Biologics Quality in FDA's Center for Biologics Evaluation and Research (CBER). On its website, Curex claims that its sublingual immunotherapy drops “are made using the same ingredients that are FDA-approved for allergy shots.”
CBER’s compliance staff judged that Curex was marketing unapproved drugs since the firm made such claims as “Curex treats people who suffer from all types of allergies,” despite having filed neither an investigational new drug application nor a biologics license application with FDA. The marketing and distribution of Curex’s sublingual drops, said CBER, “appears to violate” both the Food, Drug & Cosmetics Act and the Public Health Service Act.
Citing 21 CFR 610.17, CBER reminded Curex that a separate license must be obtained when licensed biological products are combined with other licensed biological products. “Accordingly, to be lawfully marketed, a mixture of licensed allergenic extracts must be the subject of an approved biologics license application (BLA),” noted CBER.
At press time, the Curex website included the following claim: “Eliminate your allergies.” Further claims on this page included the following characterization of the drops: “Backed by more than 100 doctors, thousands of satisfied patients, and powered by technology, Curex offers an innovative, clinically-proven path to long-term allergy relief.”
A patient testimonial on the same page reads, “No antibiotics, no inhalers, no steroids... just three drops under my tongue in the morning. It’s a miracle!”
According to the website, treatment with Curex sublingual immunotherapy begins with a review of allergy testing results and medical history by a “clinical team,” after which the team can “confirm eligibility and prescribe the custom compound.” The “uniquely created” drops are then shipped by a pharmacy for daily use, after which “Allergies start to subside.”
Clifford Bassett, MD, is an allergist in private practice in New York and a clinical assistant professor at NYU Grossman School of Medicine, New York; his testimonial on the Curex website reads, “Curex daily immunotherapy drops comprise micro doses of allergens that retrain your immune system and slowly build up long-term resistance to allergies. Curex drops are just as effective as allergy shots, but without the needles or expensive office visits.”
In its “About Curex” section, the website claims that its mission is to “empower other allergy-sufferers with a more innovative way to diagnose, educate and treat their underlying condition–not just the symptoms–so they can live better lives.”
Mary Malarkey, the author of the letter and the director of CBER’s Office of Compliance and Biologics quality, requested a response within 30 days, after recommending that Curex review the relevant FDA guidance that addresses mixing, diluting or repackaging biological products outside the scope of an approved BLA.
CBER untitled letter


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Tags: biologics, CBER, FDA, US

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