22 SEPTEMBER 2019 • WORLD AQUACULTURE • WWW.WAS.ORG and efficacy data. Further, the recommendations of these panels are expected to lead to the addition of 20 animal drug index listings each year. Twelve years later that should amount to 240 indexed products, not the 13 we have now. So what happened, and more importantly how can we hope to finally enjoy the fruit of something as monumental as MUMS and the indexing process? Agency Policy versus Law At the 25th annual Aquatic Animal Drug Approval Program (AADAP) meeting in July 2019, during a panel discussion dealing with a wide variety of topics, the question was asked why aren’t there more indexed drugs for non-food life stages of foodfish, including broodstock. The authoritative response from the Director of the Office of MUMS was that this option was deemed ineligible many years ago and that the reason was not a policy decision but embedded in the law itself. Because my focus is on ornamental aquaculture, the designation that broodstock of foodfish were ineligible for indexing wasn’t a huge concern of mine or my main clients. Like others I just assumed that, if FDA CVM says the law doesn’t allow it, then that’s the end of the conversation. However, given the failure to get legal products for aquaculture approved faster and cheaper since MUMS passed, I decided to investigate this statement further. What I found was that it is FDA’s interpretation of the law that is the impediment to indexing many of the products. Below are a few relevant sections of the law and the policy. The first two are the text found in the Act itself and the subsequent Code of Federal Regulations. The third is text in a Guidance for Industry document from CVM, essentially their policy. • Minor Use and Minor Species Health Act (Public Law 108-282-Aug. 2, 2004, Sec. 572. Index) The Secretary shall establish an index limited to - (a)(1) (A) new animal drugs intended for use in a minor species for which there is reasonable certainty (emphasis added) that the animal or edible products from the animal will not be consumed by humans or foodproducing animals; and (B) new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, non-food life stage of a food-producing minor species where safety for humans is demonstrated in accordance with the standard of section 512(d) (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance). For those of us around in the late 1990s and early 2000s as members of the Minor Use and Minor Species (MUMS) coalition, there was probably nothing as significant or important as the effort to change the way we approve drugs and therapeutants for aquaculture animals. Until then all animals were treated the same when it came to getting a label through the US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM), including a lengthy and cost-prohibitive approval process. All major species — domestic dogs and cats, cattle, pigs, horses and poultry — have markets large enough to justify the high costs of traditional labeling, but how do you get a drug for a parakeet, an alpaca or a dwarf cichlid? MUMS! MUMS was the direct result of an earlier law, the Drug Availability Act, passed in 1996, in which Congress directed the Secretary of Health and Human Services to consider and announce proposals to address the issue. The FDA concluded that statutory changes were required and then created the idea and initial guidelines for MUMS. The MUMS coalition that formed in 1998, with over 80 members (Table 1, page 25), represents a broad and highly diverse group, including the National Aquaculture Association. In 2004 the effort was rewarded with the passage of the MUMS Act and in 2005 the rules were published in the Code of Federal Regulations (CFR). Perhaps one of the most important changes within MUMS was the inclusion of a provision for indexing products for minor species, which allows unapproved, legal use in non-food animals or in non-food life stages of food animals. Although indexing still required being able to demonstrate efficacy, human health safety and environmental safety, the review and approval process for indexing is much quicker and easier. However, after 14 years of MUMS, there are only 13 indexed products (Table 2, page 26) and only two of those are for aquaculture (Ovaprim and Aquacalm, both indexed for ornamental fish only). The FDA itself estimated a much higher number of indexed products when they were developing their final rules. Taken from the Federal Register Volume 72, Number 234 (72 FR 69107; 12/6//2007), FDA summarized their own expectations as follows: The final rule is expected to result in about 30 requests for a determination of eligibility for indexing for 60 products annually, or 2 per requestor. We estimate that requestors for 20 of these products will create and convene expert panels to review the safety The Failure of MUMS and Aquaculture Indexing Craig Watson MUMS was the direct result of an earlier law, the Drug Availability Act, passed in 1996, in which Congress directed the Secretary of Health and Human Services to consider and announce proposals to address the issue. The FDA concluded that statutory changes were required and then created the idea and initial guidelines for MUMS. The MUMS coalition that formed in 1998, with over 80 members, represents a broad and highly diverse group, including the National Aquaculture Association. In 2004 the effort was rewarded with the passage of the MUMS Act and in 2005 the rules were published in the Code of Federal Regulations (CFR).
RkJQdWJsaXNoZXIy MjExNDY=