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FDA: Drug companies must estimate sales of antimicrobials by species
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Under a revised rule finalized today, the FDA will require drug sponsors to submit annual sales estimates for antimicrobial drugs that are categorized by particular species of food-producing animal, in addition to the overall estimates that the agency already mandates.
The rule, which takes effect this year, pertains to the four major food-producing categories of animal species: cattle, chickens, swine and turkeys.
In a news release, the FDA said new sales data gleaned from the revised estimates will help it better understand how companies sell and distribute antimicrobials for use in these animals and will support the agency’s effort to reduce the overuse of medically important antimicrobials.
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) already required the companies to report such sales and distribution data, but did not require separate estimates for particular species.
The agency said requiring such estimates will complement a plan to obtain additional data about on-farm use and resistance that is being developed along with the CDC and Agriculture Department.
Figure 1. The FDA now requires drug sponsors to submit annual sales estimates for antimicrobial drugs that are categorized by particular species of food-producing animal, such as cattle.
Source: Shutterstock
“This information will further enhance FDA’s ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine,” William T. Flynn, DVM, MS, deputy director for science policy in the FDA’s Center for Veterinary Medicine, said in the release.
Another revision to the rule requires the FDA to release annual summary reports based on the data provided by the companies no later than Dec. 31 the following year.
In December 2013, the FDA proposed a plan to phase out the overuse of antimicrobial drugs in livestock to reduce resistance in both animals and humans. Even with this effort, the agency announced last December that sales of medically important antimicrobials for food-producing animals increased 3% in the previous year despite the agency’s requests that pharmaceutical companies voluntarily remove FDA-approved indications for antibiotic use in these animals by December 2016, and discontinue over-the-counter sales of the drugs.
The FDA said it revised the ADUFA rule governing how antimicrobial estimates are submitted by companies after taking into consideration “hundreds of public comments from the veterinary community, animal feed manufacturing and livestock production associations, drug manufacturers, consumer groups and other stakeholders.” – by Gerard Gallagher
Reference:
FDA. Antimicrobial animal drug sales and distribution reporting. 2016: https://www.federalregister.gov/articles/2016/05/11/2016-11082/antimicrobial-animal-drug-sales-and-distribution-reporting. Accessed May 10, 2016.
Disclosure: Flynn is deputy director for science policy in the FDA’s Center for Veterinary Medicine.