Industry acceptance of the FDA’s Guidance 213, which calls on companies to phase out performance or production label claims for medically important antimicrobials has been positive.
Earlier this week, we reported that members of the Animal Health Institute (AHI) and the Generic Animal Drug Alliance (GADA) announced their written commitments to align all affected products with the FDA policy on judicious use of antibiotics.
On Thursday, March 13, the FDA issued the following statement, also indicating industry acceptance and willingness to comply with the guidance:
On December 12, 2013, as part of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, FDA asked the animal pharmaceutical industry to notify the agency in writing within 90 days of its intent to engage with FDA as defined in Guidance #213. This final guidance lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications and place therapeutic uses under veterinary oversight.
As of March 12, 2014, FDA has received responses from all of the sponsors affected by this guidance and is currently reviewing and analyzing those responses. We are encouraged by the positive response thus far. We will issue a more detailed update later this month concerning the sponsors that have committed to seeking withdrawal of approval relating to production uses and changing the marketing status of their products from over-the-counter to use by Veterinary Feed Directive or prescription. FDA intends to keep the public apprised of progress.