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Regulatory Focus™ > News Articles > Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry

Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry

Posted 18 October 2012

Representative Henry Waxman (D-CA), the ranking member on the House Energy and Commerce Committee, is preparing to introduce legislation that would increase the amount of information required of manufacturers who produce antibiotics for use in animals.

The legislation would require the US Food and Drug Administration (FDA), which recently released an advanced notice of public rulemaking on the topic of antibiotic monitoring and use, to "increase information on the amount and use of antibiotics in animals raised for human consumption."

Such use has been a controversial topic in recent years, with some public advocacy groups calling on FDA to cut down on the routine use of antibiotics. In June 2012, Judge Theodore Katz called FDA's current antibiotic monitoring and use policies, "Arbitrary and capricious," and ordered the agency to take action to phase out the use of antibiotics in animal feed.

The DATA Act

While Waxman's legislation, the Delivering Antibiotic Transparency in Animals (DATA) Act, wouldn't take action to remove antibiotics from feed, it would set the stage for requiring manufacturers to provide FDA with data on how their products are used on farms.

"We need reliable information about the use of antibiotics in agricultural operations," said Waxman.  "The more we learn, the graver the threat becomes from overuse of antibiotics by industrial-scale farms.  We need this information so scientists and Congress can stop the spread of drug-resistant infections from farm animals to humans."

Waxman said his pending legislation would also require feed mills to report the use of antibiotics in animals, which he said should close an important gap in reporting and enhance the quality of information available to regulators. The data will reportedly include information on the types, purposes and quantities of antibiotics given to animals through their feed.

The legislation has received the support of some public health advocacy groups, including the Pew Health Group. They noted the bill could assist the public and industry in figuring out if FDA's approach, ordered by Katz, is in fact working.

"In April, the FDA issued draft voluntary guidance to limit the overuse and misuse of antibiotics," wrote Laura Rogers, project director for the Pew Campaign on Human Health and Industrial Farming. "Rep. Henry Waxman's (D-CA) proposed legislation would enable the FDA and the public to verify whether the agency's efforts are actually working."

Mirrors Comments by Other Legislators, FDA

Waxman's call mirrors one made in August 2012 by a bipartisan group of 13 senators, which in addition to calling for more information also called for FDA to tighten its now-voluntary restrictions on the use of antibiotics in animals. The standards, which take the form of a guidance document released in April 2012, are strictly voluntary and some critics say they will do little to actually stem the problem of the overuse of antibiotics.

Overuse has been linked with the acceleration of drug-resistant bacteria in both humans and animals, which could lead to the current generation of antibiotic medications being rendered useless if trends continue.

FDA has also taken action similar to the intent of Waxman's bill. In July 2012, it introduced an advanced notice of public rulemaking to require manufacturers to provide it with more data on the use of antibiotics in animals. The introduction of that rule was delayed in September 2012 after FDA said it was extending the public comment period in order to collect additional comments.

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