FDA Reports that 25 of 26 Antibiotic Makers Will Comply with New Policies

On March 26, the U.S. Food and Drug Administration announced that 25 out of 26 drug companies that sell antibiotics for growth promotion “confirmed in writing their intent to engage with FDA as defined in Guidance #213.” FDA introduced this policy in final form Dec. 11, 2013, to curb antibiotic overuse and increase veterinary oversight on industrial farms.

To comply with Guidance 213, these companies will remove “growth promotion” from their products' labels, which will effectively make it illegal for those drugs to be used for that purpose. In addition, drug companies have agreed to move all remaining uses of in-feed and in-water drugs to either prescription or veterinary feed directive status. This is designed to bring over-the-counter uses to an end and ensure that veterinarians oversee the use of these drugs.

FDA reports that these drugs account for “99.95% of the total sales of products affected by Guidance #213.”

“The FDA and drugmakers appear to have passed the first big test of the agency's voluntary approach,” said Laura Rogers, director of The Pew Charitable Trusts' project to curb antibiotic overuse on industrial farms. “This is very encouraging—as is the agency's transparency in reporting this information today—but there's a lot more to do. In particular, FDA needs to clarify how it will curb the use of these drugs to compensate for overcrowded and unsanitary conditions, and how it will collect more and better antibiotic data so it can tell on which species and for which purposes these drugs are being used. The agency needs this information to calculate the ultimate measure of success—declines in nontherapeutic antibiotic use and fewer resistant infections in animals and people.”

For more information:

• Pew's brief on the FDA's guidances and draft veterinary feed rule work, and where improvements are needed.
• In 90 days, more than 200,000 people submitted comments in response to the draft veterinary feed directive rule, urging stronger veterinary oversight of antibiotics.
• Senator Elizabeth Warren (D-MA) questioned FDA Commissioner Margaret Hamburg on this issue at a March 13 FDA oversight hearing.