To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

Posted 19 May 2015 | By Alexander Gaffney, RAC 

To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species.

The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR).

Under the 2008 Animal Drug User Fee Act (ADUFA), sponsors of approved animal drugs containing one or more antimicrobial ingredients are required to submit annual summary reports on the amount of their product that is sold for use in food-producing animals.

Specifically, companies are currently supposed to collect and submit information regarding the antimicrobial active ingredient in each of the products sold, the amount of the product sold domestically, the amount of product sold for export and the animals the drug is approved for use in.

But some public health advocates have complained the current collection of data lacks nuance. For example, it doesn't indicate how much of the antibiotic is used in a specific species.

Under FDA's newly proposed rule, that would change.

The rule, Antimicrobial Animal Drug Sales and Distribution Reporting, still requires companies to include information traditionally required in the reports, including:

  1. A listing of each antimicrobial active ingredient contained in the product;
  2. A description of each product sold or distributed by unit, including the container size, strength, and dosage form of such product units;
  3. For each such product, a listing of the target animal species, indications, and production classes that are specified on the approved label;
  4. For each such product, the number of units sold or distributed in the United States (i.e., domestic sales) for each month of the reporting year; and
  5. For each such product, the number of units sold or distributed outside the United States (i.e., quantities exported) for each month of the reporting year.

However, companies will now be required to include information estimating how much of each antimicrobial product was distributed domestically for use in cattle, swine, chickens or turkeys. If companies are unsure of how much of a product was distributed to a specific animal, they can report that the exact amount is "other species/unknown."

FDA is also instructed under the rule to treat sales and distribution information as commercially confidential, making it exempt from FOIA requests.

“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,” said Michael Taylor, FDA's deputy commissioner for foods and veterinary medicine, in a statement.

“We plan further actions to complete the task," he added.

A public comment period on the rule is open for the next 90 days.


FDA Proposed Rule

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