US Senators Kirsten Gillibrand, Dianne Feinstein and Susan Collins have introduced bipartisan legislation aimed at combating antimicrobial drug resistance. The Antimicrobial Data Collection Act calls for increased data collection by the Food and Drug Administration (FDA), enhanced transparency and public awareness of antimicrobial drug use in agriculture and strengthened FDA accountability regarding unsafe antimicrobial drug use. The Centers for Disease Control estimates that, each year, antimicrobial resistance costs taxpayers $20 billion in excessive healthcare and results in more severe illness and a greater risk of death for infected patients. Currently, there are at least six multidrug resistant major human pathogens.
“Antimicrobial resistance is a public health concern that needs to be adequately addressed,” said Senator Gillibrand. “Increased data collection, transparency, and accountability are part of a comprehensive solution that will help protect American citizens from drug resistant microbes, saving lives and tax dollars.”
“Our bill would not create any new reporting requirements for drug companies, feed mills, or farmers. It would only require the FDA to provide more transparency in reporting the antimicrobial data which is already being reported to it,” said Senator Collins.
Specifically, the legislation requires a pilot program to look into new data sources on antibiotics used on food producing animals. The FDA will create a comprehensive data collection strategy, based on the new data sources, in order to increase data availability to the public, increasing the FDA’s transparency. The FDA’s increased transparency would shed light on information about antimicrobial drugs used in agriculture that are not currently made public, such as dosage form, strength and targeted animals. The Government Accountability office will then audit the FDA to determine if the data collection for antimicrobial resistance programs is effective in protecting public health.
Pew Welcomes the Act's Introduction
The Pew Charitable Trusts has applauded Senators Kirsten Gillibrand (D-NY), Dianne Feinstein (D-CA), and Susan Collins (R-ME), for introducing the Antimicrobial Data Collection Act, which would require the US Food and Drug Administration, or FDA, to report more information on the annual sales of antibiotics used among industrial farm animals. The bipartisan bill would also give the agency a deadline to finalize policies proposed last year to eliminate the use of antibiotics for growth promotion purposes in meat production.
Laura Rogers , director of Pew's effort to reduce antibiotic overuse in food animal production, commeted: "This bill is critical to helping us understand how antibiotic overuse on industrial farms is affecting human health. While decades of science clearly show that these practices breed drug-resistant bacteria that can infect us, we need to know more about the scope of the problem. Unfortunately, the Senate Health, Education, Labor and Pensions Committee recently missed an opportunity to enhance transparency about antibiotic sales in meat production in the Animal Drug User Fee Act. But we commend Senators Gillibrand, Collins and Feinstein for their bipartisan leadership and urge the Senate to swiftly pass this legislation."
Pew says that the bill introduced by the three senators includes several provisions to require FDA to report antibiotic sales publicly, comprehensively, and predictably. Under the bill, the agency's reports on these sales would be broken down by dosage form (in feed, in water, or by injection), marketing status (that is, whether they are available over the counter or by veterinary order), and indication of whether the drugs are important in human medicine. FDA would be required to publish the reports by a deadline set each year. The agency issued its 2009 sales report on 9 December 2010, its 2010 report on 31 October 2011 and its 2011 report on 6 February 2013.
In addition, within 180 days of its enactment, the bill would require FDA to finalise a set of policies aimed at eliminating the use of antibiotics for making food animals grow faster. Nearly 220,000 Americans, including leading health advocates such as Pew, have asked FDA to close loopholes in these policy documents and to publish them quickly. Pew has also urged the agency to "issue binding regulations that will further restrict the way antibiotics are used in food animal production."
In the House, Representatives Henry Waxman (D-CA) and Louise Slaughter (D-NY) on 26 February 2013, introduced the Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820), which also requires FDA to report more detailed antibiotic sales and information on use in food animals.