GAO chides federal agencies for lack of data on antimicrobial use, resistance

NATIONAL REPORT — The federal agencies charged with monitoring antimicrobial use and resistance are not doing a good enough job of collecting data, according to a new report from the Government Accountability Office (GAO).

The U.S. Food and Drug Administration (FDA) has been tracking the amounts of antibiotics sold, but GAO contends the data shines little light on what those antibiotics are used for and in what species.

Other federal departments have been using existing surveys to track antimicrobial use and resistance data, but those surveys were not designed to collect such data and have left the agencies unable to predict trends. And none of the departments work collaboratively, GAO says.

Data collection

The Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) are the two federal departments primarily responsible for ensuring the safety of the food supply, including the safe use of antibiotics in food animals. Within those two departments, eight different agencies are tasked with roles in tracking antimicrobial use and resistance. In 1999, GAO reported that despite more than two decades of discussion, federal agencies failed to reach an agreement on the safe use of antimicrobials in food animals. In 2004, GAO recommended HHS and USDA jointly develop a plan for collecting data on antibiotic use in animals. But in the latest report, GAO notes that despite agency agreement with the recommendation, neither HHS nor USDA have implemented it, and the departments continue to collect data independently.

The most recent report is not the first time GAO called federal agencies to task for not working together. Biennial reviews in 2009 and 2011 both concluded "the fragmentation of federal food safety oversight continues to be a problem."

An interagency plan developed in 2001 to help federal agencies coordinate efforts related to antibiotic resistance contained 84 action items involving surveillance, prevention and control, research and product development. But GAO says data collected under the plan is not sufficient for identifying trends. Public health organizations interviewed for the report say the federal government needs to collect more information on the purpose of antibiotic use. But officials from various agencies tell GAO that detailed information on antimicrobial use is difficult to collect for several reasons. First, producers do not always maintain records on antibiotic use. Second, producers who do collect data may be reluctant to provide it to the federal government voluntarily, GAO reports, adding that FDA is looking into its legal options for requiring producers to report antibiotic use.

Collecting data from veterinarians can also be a challenge since many antibiotics can be purchased without veterinary involvement. Additionally, even for prescription antibiotics, veterinary records can be difficult to obtain, GAO says.

"A veterinary organization we spoke with stated that it would be cumbersome for veterinarians to provide this information to an agency because there is no centralized reporting mechanism, such as an electronic database," the report states.

Feed mills maintain records on antibiotics mixed into animal feed, including the amount used and the type of feed the antibiotic went into. An official from the animal-feed industry told GAO that, although feed mills don't intentionally track antibiotic use by species, they do track information that could be used for that purpose. But FDA officials told GAO that collecting use data from feed mills would require the agency to develop a new reporting mechanism.

Several programs for collecting data on farms have been tried by federal agencies, but were subsequently discontinued due to lack of funding or high costs of implementation, GAO says.

Denmark's model

The report notes that while U.S. agencies have found collecting data on antimicrobial use and resistance difficult, other countries, like Canada and Denmark, have adopted approaches that have been more successful. But all antibiotics used in Denmark are by prescription, which offers a key advantage in gathering data. Prescription data yields information on the medicine being prescribed, the intended species and age group, the prescribed dose, the prescribing veterinarian and the source farm. Data also is gathered from domestic and imported meat samples through slaughter plants. The data collection is done voluntarily at the expense of the industry, the GAO report says.

Denmark also increased its oversight of veterinarians, limiting veterinarians' profit on sales of antibiotics. In 2005, Denmark initiated biannual audits of swine veterinarians because this segment of the market uses about 80 percent of all food-animal antibiotics in the country. In 2007, the audits were expanded to all food-animal veterinarians. Last year, Denmark began a new "yellow-card initiative" setting regulatory limits on antimicrobial use at swine farms based on the size of the farm. Exceeding the regulatory limit results in increased government monitoring that the farm must pay for. As a result of these and other regulatory measures, antibiotic use in Denmark declined from 1994 to 1999, increasing from 1999 to 2009 while still remaining below 1994 levels. Antibiotic use in pig production fell 25 percent over the last year in response to the yellow-card initiative, the GAO report states.

What the actions in Denmark have not shown, according to GAO, is a decrease in antibiotic resistance in humans after implementation of the various programs, except in limited cases.

While food-animal producers in the United States have expressed concern that reductions in antibiotic use may lead to an increase in food-borne pathogens on meat, Denmark officials contend their data shows no increase in these bacteria on meat products.

As of September 2010, 10 countries in Europe collected data on sales of antibiotics used in food animals, and five of those countries collected species-specific data. Another 12 countries have recently started or plan to begin collecting antibiotic sales data.

Tracking antibiotic sales

Since GAO last visited the issue of antimicrobial resistance in 2004, FDA has been collecting data from drug companies on the number of antibiotics sold for use in food animals, but existing data do not indicate what species the antibiotics are used for or whether the antibiotics were used to treat disease or for growth promotion. USDA agencies collect use data through existing surveys of producers, but they only provide a limited snapshot of antimicrobial use, GAO says.

"Without detailed use data and representative resistance data, agencies cannot examine trends and understand the relationship between use and resistance," GAO concludes.

FDA has been stricter in allowing approvals of new antibiotics without drug makers first proving they will not contribute to resistance, according to the GAO report. However, most of the antibiotics were approved prior to this strategy being put into place in 2003, and withdrawing approvals can be costly. When FDA sought to withdraw two types of fluoroquinolones in 2000, one drug manufacturer pulled the drug voluntarily. Another challenged FDA and, while the drug approval was eventually withdrawn, the cost of the legal battle was estimated at $3.3 million. Instead of pursuing approval withdrawals, FDA proposed a strategy in June 2010 to promote the "judicious use" of antimicrobials in food animals. The plan calls for veterinarians to limit antibiotic uses to medical necessity and asks that antibiotic use be undertaken with increased veterinary oversight. But, like many of the other federal programs used to change antibiotic usage or educate on antimicrobial resistance, FDA is depending on voluntary cooperation and has no system in place to measure the effectiveness of the program.

Antimicrobial alternatives

Another previous recommendation revisited by GAO involves federal research into alternatives to antibiotic use. Since 2001, some research has been initiated, but officials were unable to provide GAO with a complete list. Additionally, officials could not provide information on whether the research helped achieve the action item for which it was intended in the 2001 interagency plan. More funding would be needed to assess the success of the research, according to several agency officials, but GAO says the agencies never provided more specific details about how many additional resources would be required. Without assessments of past research efforts, GAO says agencies will be limited in their ability to identify gaps where additional research is needed.

"Tracking progress and making sound decisions is particularly important in light of the fiscal pressures currently facing the federal government," GAO states.

Neither Denmark nor the EU conduct research on alternatives to antimicrobial use, but the EU offers incentives to spur research in private industry. According to the report, the EU lengthened patents on such products, resulting in a reduction in competition from generic companies. GAO says the practice has led to more than 300 applications for new feed additive products in the EU.

Additionally, HHS sponsored six programs to educate DVMs and producers on appropriate antibiotic use, but said it had no plans to develop future programs. The Center for Disease Control and Prevention hosted three national animal health conferences on antibiotic use and resistance, and spent about $1.7 million on the Get Smart on the Farm campaign from 2003 through 2010, but never assessed the impact of any of the programs, GAO notes. USDA also sponsored education programs without assessing their impact after the fact.

Representatives from veterinary and producer organizations tell GAO that industry-led efforts are responsible for most of the progress in antimicrobial use education over the last decade. Those same organizations tell GAO they believe the federal government should have a role in educating producers and veterinarians about antimicrobial use, but say those activities should be done in collaboration with industry groups.

Action items

GAO recommends the following steps in its report:

• That the secretaries of USDA and HHS identify potential approaches for collecting detailed data on antibiotic use in food animals, collaborate with industry to select the best approach, seek the resources necessary to implement the resulting plan, and use the data collected to assess the effectiveness of policies to curb antibiotic resistance.

• The HHS and USDA direct agencies to modify sampling of foodborne pathogens in retail meat to make the data more representative of antibiotic resistance in food animals and retail meat throughout the United States.

• That HHS and USDA assess previous research efforts on alternatives to identify gaps where additional research is needed in collaboration with the animal-production industry, and specify in the draft 2010 interagency plan the steps agencies will take to fill those gaps.