18 SEP TEMBER 2022 • WORLD AQUACULTURE • WWW.WA S .ORG The OMUMS listened and heard and last summer issued a Federal Register Request for Public Comment that asked whether OMUMS should expand indexing eligibility to “discrete subsets of food-producing minor species” where there was reasonable certainty that that subset would not enter the human food chain. The comment period closed in September and was overwhelmingly positive towards changing the existing policy and expanding eligibility for indexing. On 25 July this year, the FDA announced that they were withdrawing their guidance on indexing and that they would consider eligibility for indexing on a case-by-case basis where there was reasonable certainty that the animals being treated would not be used as food (see Text Box for the full FDA-CVM announcement). On the following day, Dr. Dorothy Bailey, who heads up the Indexing program for OMUMS, gave a presentation reaffirming their decision at the Aquatic Animal Drug Approval Program (AADAP) meeting in Bozeman, MT. During her presentation, she outlined their new policy and encouraged the audience to submit requests for eligibility, especially for broodstock fish, even while OMUMS works on rewriting the guidance for indexing. Hopefully, this new direction will lead to a number of drugs for broodstock fish that have been making their way through the New Animal Drug approval process being added to the Index and becoming legally available to our farmers. This development proves to me the value of an organization like the NAA, and the commitment of a few federal employees that were willing to listen Three years ago, along with the National Aquaculture Association (NAA), I began an effort to advocate that the Food and Drug Administration’s Center for Veterinary Medicine (CVM) change their policy for determining what was eligible for drug indexing. We pointed out that the policy was overly restrictive and had led to only two drugs being indexed for fish since the Minor Use and Minor Species Animal Health Act (MUMS) was passed in 2004. MUMS allows indexing for non-food animals or early life stages of food producing species, although CVM’s previous policy was that, if any animal within a species was raised for food, that entire species was not eligible. In an article published in the September 2019 issue of World Aquaculture, we explained how there are many instances where there are members of a species that are used for food, but the animal in question is not. Broodstock fish was the main example we used. Shortly after the article was published, members of the CVM’s Office of Minor Use and Minor Species (OMUMS) reached out to the NAA to discuss the issues. Other groups, including animal research labs, had made similar arguments, and it was quickly apparent that OMUMS was interested in exploring a change in the policy, if possible. The NAA then conducted a national survey of private and public hatcheries that showed, except in a very few cases (e.g., state agencies stocking public waters), none sold or used broodstock as food for people or for food-producing animals, and if they did, they could easily cease doing so if it meant getting legal access to drugs. The Office of MUMS Changes Course on Indexing Eligibility Craig Watson FDAWithdraws Guidance on Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species The U.S. Food and Drug Administration has withdrawn guidance for industry (GFI) #210, “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species,” in order to revise it in accordance with a statutory change to the wording of required label statements and because the guidance no longer represents the agency’s current thinking. The FDA plans to issue a revised draft guidance as expeditiously as possible. The FDA published final GFI #210 in April 2018, which included guidance on a statutory requirement at the time to label products on the Index with the statement “Not Approved by FDA.”With the recent statutory change, this statement has beenmodified for products that are part of the Index. Additionally, the FDA received feedback regarding guidance #210 in response to a Request for Information in June 2021 asking for stakeholder feedback on expanding eligibility for Indexing for certain groups of animals from foodproducing species when there is reasonable certainty that those animals would not enter the food supply. The vast majority of comments received in response support the contention that there is a “reasonable certainty” that certain subsets of minor species generally considered to be food-producing animals will not be used as food for humans or food-producing animals, including laboratory rabbits and broodstock fish. As we consider these comments, we encourage potential requestors for Indexing to consult GFI #201, “Small Entities Compliance Guide for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species,” and consult with the agency’s Office of Minor Use &Minor Species (OMUMS). OMUMS will determine the eligibility of a drug for Indexing on a case-by-case basis. ( C O N T I N U E D O N P A G E 1 9
RkJQdWJsaXNoZXIy MjExNDY=