A bipartisan group of U.S. senators this week asked the U.S. Food and Drug Administration to be more transparent when they publish data regarding the use of antimicrobial drugs in food animal production.
The lawmakers, including Sens. Tom Harkin (D-IA), Lamar Alexander (R-TN), Dianne Feinstein (D-CA), Kirsten Gillibrand (D-NY) and Mark Kirk (R-IL), most of whom serve on the Senate Health, Education, Labor, and Pensions Committee, said in a letter to FDA Commissioner Margaret Hamburg that they support FDA’s recent efforts to encourage veterinary pharmaceutical drug companies to drop growth-promotion claims form their antimicrobial labels and to rein in injudicious uses. But the senators are asking FDA go a step further and set “a clear timeline” to develop an antimicrobial data collection strategy based on the comments the agency has received from stakeholders.
The senators want FDA, along with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention, to conduct a needs assessment to figure out what data the agency needs regarding antimicrobial uses. They also asked that FDA publish the assessment and present it to Congress. On top of that, they want the agency to report more detail, such as dosage and container size, in the next antimicrobial sales report.
Health advocates have long sought more data on the use of antibiotics in food animal production in an attempt to more definitively link the use of a particular antibiotic product to the level of resistance among pathogens. Recent attempts to mandate that FDA collect and report more data, as part of the Animal Drug User Fee Act, have failed.
The letter said that reporting more data will give scientists what they need to “further evaluate the effectiveness of current public health programs.”
The senators requested that FDA finalize the Draft Guidance for Industry 213 “as soon as possible” to help eliminate the “injudicious uses” of the drugs in agriculture and they also want to see a plan to evaluate the policy going forward.
