Regulatory Focus™ > News Articles > FDA Wants More Data on Antibiotics

FDA Wants More Data on Antibiotics

Posted 27 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released an advanced notice of proposed rulemaking-the precursor process for promulgating a regulation-saying it wants to reassess the information collected from industry regarding  veterinary antimicrobial drug sales, distribution and resistance data.

In an advanced Federal Register posting, FDA said it is considering the changes through  statutory authority given to it under section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). Under the legislation-which was negotiated between the agency and industry before being marked up and approved by legislators-FDA requires 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 now wants to solicit comment from industry on whether it is 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.

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."


Read more:

FDA - FDA Solicits Comments Related to the Collection of Sales and Distribution Data of Antimicrobial Animal Drugs

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