The US Food and Drug Administration’s vaccines advisory committee now will handle allergenic products following the termination of a panel created 40 years ago to deal with the rarely seen applications.
Key Takeaways
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The FDA terminated the Allergenic Products Advisory Committee because the effort and expense to maintain the committee can no longer be justified given its infrequent meetings.
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Since 2009, the committee met on a total of 10 days and only four of the meetings involved application-specific reviews.
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The panel’s responsibilities will be given to the Vaccines and Related Biological Products Advisory Committee.
The FDA ended the Center for Biologics Evaluation and Research’s Allergenic Products Advisory Committee effective 9 July and removed it from the agency’s list of standing committees.
“Over the past several years, the committee has met infrequently,” a 10 July Federal Register notice stated. “As such, the effort and expense of maintaining the committee can no longer be justified.”
The terminated committee’s responsibilities will be integrated into the Vaccines and Related Biological Products Advisory Committee’s charter to ensure that the FDA may seek independent expert input on allergenic biological products.
Ending 40 Years Of Service
The Allergenic Products Advisory Committee was established in July 1984 to review and evaluate data on the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease.
The committee also made recommendations to the commissioner on “the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to regulations governing the manufacture, testing and licensing of allergenic biological products, and on the quality and relevance of FDA’s research programs that provide the scientific support for regulating these agents,” according to its charter, which is no longer on the FDA’s active website.
The allergenic products panel charter states that meetings shall be held approximately twice a year. In reality, the committee hit that mark only three times in the past 15 years.
The committee had nine voting members, including the chair, with expertise drawn from allergy, immunology, pediatrics, internal medicine, and biochemistry fields, and related specialties. The members also could have included a voting consumer representative, as well as a nonvoting industry representative.
As of 1 April, the committee website listed four voting members, including the chair, and six vacancies.
The estimated annual cost for operating the committee, including member compensation and travel expenses, but excluding staff support, is $138,140. The estimated person years of staff support required is 1.60, at an estimated annual cost of $265,707, the charter states.
The allergenic products panel charter also said that meetings shall be held approximately twice a year. In reality, the committee hit that mark only three times in the past 15 years.
Since 2009, the committee met on a total of 10 days, according to a Pink Sheet analysis. The panel considered product-specific applications at only four of the meetings, the most recent being Aimmune Therapeutics, Inc.’s peanut allergy immunotherapy Palforzia in September 2019. (Also see "Aimmune’s Palforzia Gains US FDA Panel Nod But Faces REMS Restrictions" - Pink Sheet, 15 September, 2019.)
Palforzia was approved in January 2020 after its review was extended by a federal government shutdown. (Also see "Keeping Track: Aimmune’s Peanut Allergen Approved; Novartis’ Inclisiran, Pfizer/Lilly’s Tanezumab, Bayer’s Nifurtimox Submitted" - Pink Sheet, 1 February, 2020.) The product has been a commercial bust and is currently owned by Stallergenes Greer Ltd, which acquired it from Nestle. (Also see "Stallergenes Greer Gets Hold Of Nestlé’s Palforzia For Peanuts" - Scrip, 4 September, 2023.) On 26 July, the FDA approved Palforzia to include initiation of treatment, up-dosing and maintenance in individuals ages 1-3 years with a confirmed peanut allergy diagnosis to mitigate allergic reactions.
Story continues after the chart …
A scheduled May 2020 meeting on DBV Technologies’ Viaskin peanut allergy patch was cancelled so the FDA could review outstanding issues. (Also see "Virtual Advisory Committees: Who Will Be First In Line To Test On-Line Meetings?" - Pink Sheet, 30 April, 2020.) The review ended with a complete response letter that sought human factors studies, supplementary clinical data and manufacturing data. (Also see "US FDA Picks Up The Pace Of Complete Response Letters Over June And July" - Pink Sheet, 5 August, 2020.)
The allergenic products committee’s termination seems likely to add only minimally to the VRBPAC workload, which has been among the more active committees in recent years due largely to the COVID-19 vaccines. Since the start of 2023, VRBPAC has met on a total of nine days.
However, the termination notice comes several months after an official said the agency likely will bring promising biomarkers for allergy and asthma treatments to an advisory committee before endorsing their use for regulatory purposes. (Also see "US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact’" - Pink Sheet, 1 April, 2024.)
Endings And Beginnings
FDA advisory committee terminations are infrequent and often due to lack of activity.
In 2015, the agency terminated the Antiviral Drugs Advisory Committee after determining it was no longer needed. (Also see "FDA Says Goodbye To Its Antiviral Drugs Advisory Committee" - Pink Sheet, 20 March, 2015.)
US FDA’s Genetic Metabolic Diseases Adcomm Debuts With Zevra’s Arimoclomol
However, some panels have been reinstated years after termination.
In 2002, the FDA announced plans to eliminate both the pharmacy compounding and medical imaging drugs advisory committees. (Also see "FDA Advisory Committee Line-Up Shrinks With Elimination Of Two Panels" - Pink Sheet, 25 November, 2002.)
The imaging drugs panel was re-established in May 2011 and the compounding panel was reconstituted in December 2014. (Also see "In With The Old? 2013 To Mark Rebirth Of CDER’s Pharmacy Compounding, Medical Imaging AdComms" - Pink Sheet, 14 January, 2013.)
The allergenic products panel’s end comes as the Genetic Metabolic Diseases Advisory Committee is approaching its first meeting on 2 August. The panel will review Zevra Denmark A/S’ arimoclomol for the treatment of Niemann-Pick disease type C, an ultra-rare lysosomal storage disorder. (See sidebar.)
The GeMDAC was created through the Center for Drug Evaluation and Research and announced in December. (Also see "Genetic Metabolic Diseases Get Their Own US FDA Advisory Committee" - Pink Sheet, 13 December, 2023.)
The FDA said that it did not have to eliminate another committee to make room for the GeMDAC. Pursuant to the Federal Advisory Committee Act, the agency may establish a new committee with approval from the General Services Administration.
