FDA Center for Veterinary Medicine Updates Guidance on Animal Drug Fees

The US Food and Drug Administration (FDA) has made some changes over the past several months regarding regulations on antibiotic use in animals and agriculture. Now, the FDA Center for Veterinary Medicine issued an update regarding animal drug review fees, waivers, and reductions.

On November 1, 2016, the FDA updated the Guidance for Industry #170 Animal Drug User Fees and Fee Waivers and Reductions. This particular guidance has been in effect since November 2003 and has been reauthorized at least twice prior to November 2016. As per the Animal Drug User Fee Act of 2003, the FDA is sanctioned to collect fees to review animal drugs for approval. The updated guidance “clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business waivers, and makes additional clarifying changes,” as stated by an update issued by the FDA.

According to the FDA guidance, an entity may request a fee waiver or reduction if it falls under the following criteria:

• The fee would present a "significant barrier to innovation," due to "limited resources" or funds
• The fee will surpass the projected FDA costs
• The animal drug will be used in "Type B medicated feed" or "Type C free-choice medicated feed"
• The animal drug is intended for "minor use" or for "minor species indication"
• The entity is a small business and this is its first animal drug application for FDA approval

The FDA update states that these fees are intended to ensure that these drugs are safe and effective for animals, including food animals, and that they will not cause harm to humans, once ingested.

The FDA will review public comments starting today through January 3, 2017. All comments should be submitted to www.regulations.gov.