Nearly five years after the passage of the Animal Drug User Fee Amendments Act (ADUFA) of 2008, the US Food and Drug Administration (FDA) is proposing to expand upon its data reporting requirements, saying companies will need to include even more data on the antimicrobial drugs they sell for use in food-producing animals.
The policy is being advanced through proposed rulemaking released on 26 September 2013 by the agency. It was first released as a proposed final rule in July 2013, wherein FDA said it was considering changes under section 105 of ADUFA.
Under the legislation, FDA required each sponsor of a new animal drug to submit an annual report to FDA on the amount of active antimicrobial ingredient in each product, as well as sales and distribution data on an aggregate level.
The agency said it wanted to expand those requirements, and wanted industry feedback on whether it would be necessary and proper for it to require sales reporting and distribution data for "antimicrobial animal drug products that are approved and labeled for more than one food-producing animal species, an estimate of the amount of each active antimicrobial ingredient sold or distributed for use in each approved food-producing animal species."
"Specifically, comments should address how sponsors can both practically and accurately provide separate sales and distribution information for each species," FDA explained. Companies may also propose new methods of data collection so long as they are within FDA's "existing authority," the agency said.
Industry weighed in on the proposed rule, saying it needed more opportunities to break down the data into more relevant parts. For example, some in industry wanted to be able to include the route of administration, dispensing status, or various indications a drug would be prescribed for.
FDA said it conceded those requests in the updated proposed rule released on 26 September.
"The proposed additions to the report expand the current format of sales and distribution data by antimicrobial class to include information on the importance of the drug in human medicine, then providing aggregate data on how the medication is administered to the animal, whether it is available over the counter or requires veterinary oversight, and whether it is used as a therapeutic, a growth promoter, or both," FDA wrote.
In addition, FDA said it would go back to previous years' reports and update those using the new format as well, presumably to allow for long-term trend tracking on a retroactive basis.
The "proposed additional data tables for the summary report on antimicrobials sold or distributed for use in food-producing animals" will include the following:
- Domestic Sales and Distribution Data Reported by Medical Importance and Drug Class
- Domestic Sales and Distribution Data Reported by Medical Importance and Route of Administration
- (Feed, water, injection or other routes of administration)
- Domestic Sales and Distribution Data Reported by Medical Importance and Indications
- (Therapeutic indications, or production and therapeutic indications)
- Domestic Sales and Distribution Data Reported by Medical Importance and Dispensing Status
- (Status: Over-the-counter, prescription or veterinary feed directive)
All reporting will be divided into "medically important" and "not medically important" categories.
Companies have until 25 November 2013 to weigh in on the new proposed rule.
Data Feeds into National Reporting Program
The data is important because it allows the agency to track trends in antimicrobial resistance in animals, said FDA. However, a recent investigation by officials at the Government Accountability Office found that the data collected under section 105 of ADUFA was insufficient to establish national trends of antimicrobial resistance in specific animals.
"Currently, sponsors of antimicrobial drugs that are approved and labeled for multiple animal species, including both food-producing and non-food-producing animals, do not report sales and distribution information for each individual animal species," FDA explained. "Only total product sales information is reported."
Having the data would assist the agency in supporting its National Antimicrobial Resistance Monitoring System (NARMS), a surveillance program that monitors antimicrobial resistance in food-producing animals and humans.
"In addition, such information would further enhance FDA's ongoing activities related to antimicrobial resistance and is consistent with the recommendations in guidance recently issued by this Agency addressing the judicious use of medically important antimicrobial drugs in food-producing animals," observed FDA.
The plan was first previewed in May 2012 when the Center for Veterinary Medicines (CVM), FDA's drug regulatory branch, released a plan detailing its goals for the NARMS program. Among the goals identified at the time was an "integrated database" of pooled data resources, a web-based collection program to assist data collection from industry, and linking its database to other federal agencies to identify trends of resistance and disease. CVM also said it hoped to obtain a better geographical representation of samples to better assess national estimates of antimicrobial resistance.
FDA's plan also comes after the release of guidance asking industry to "voluntarily limit" the use of medically important antibiotics, particularly in animal feed. At the time, FDA said the actions were "critical … to protect public health."