Since the FDA released its Guidance for Industry #213 in December 2013, all but one affected company have committed in writing to comply with the voluntary guidance. And the committed companies market over 99 percent of the drugs affected by the guidance FDA announced this week.
Guidance 213 directs companies to seek withdrawal of approvals for production use of antimicrobial drugs determined to be important in human medicine.
FDA also is working with animal-health companies to change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.
Activists and groups opposed to the use of antimicrobials in livestock production have been critical of Guidance 213, claiming its voluntary nature would not compel companies to change their labels and therefore would not help slow development of antimicrobial resistance among pathogen populations.
In a March 26 release, FDA says it is encouraged by the strong response thus far and will continue to monitor ongoing participation and provide public updates on a periodic basis.
Earlier this month, 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.
According to the FDA:
- The number of affected sponsors is 26.
- 25 sponsors confirmed in writing their intent to engage with FDA as defined in Guidance #213 and have given FDA consent to list their names in this update.
- These 25 sponsors hold 99.6 percent of the applications affected by Guidance #213.
- These applications represent 99.95 percent of the total sales of products affected by Guidance #213, based on 2011 data.