FDA proposes to expand animal drug data to include information about species

The Food and Drug Administration (FDA) has proposed to expand animal drug data to include information about species.

Every year, the agency carries a summary of the information that the animal drug sponsors need to report every year by the Animal Drug User Fee Act (ADUFA), but the data is usually broken down by drug class.

The public health community is facing an issue that sales and distribution information is not directly correlated with how the drugs are actually used.

On Tuesday, FDA proposed a rule that would add estimates of sales by animal species, including cattle, swine, chickens or turkeys. It also included a provision that required FDA to publish its annual summary report of antimicrobial sales and distribution information by December 31 of the following year in order to make the release of data in time.

Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, said, “Consistent with data collection objectives outlined in the Administration’s National Strategy for Combating Antibiotic-Resistant Bacteria, this proposed rule is a step toward providing more detailed information to the FDA and the public on changes in antimicrobial sales and distribution over time”. He added that they have planned the further actions to complete the task.

Gail Hansen, senior officer of the antibiotic resistance project at The Pew Charitable Trusts, said that different species are raised in different ways due to which species-specific data are necessary.

FDA has noted that by adding species-specific information it will be able to help provide a fuller picture of antimicrobial use, and that the data about on-farm use by species and purpose are what’s ultimately needed for the proper understanding of the links between usage and trends in resistance.

The agency stated that FDA is actively engaged with the US Department of Agriculture, Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need.