Regulatory Focus™ > News Articles > FDA 'Aiding and Abetting' Industry Attempts to Skirt Antibiotic Reporting, Says Former Commissioner

FDA 'Aiding and Abetting' Industry Attempts to Skirt Antibiotic Reporting, Says Former Commissioner

Posted 29 March 2013 | By Alexander Gaffney, RAC

Former US Food and Drug Administration (FDA) Commissioner David Kessler is concerned about the regulation of antibiotics.

Taking to the opinion pages of the New York Times this week, Kessler, who served as FDA commissioner from 1990 to 1997, wrote that the agency has done a poor job at pressing legislators for more authority to regulate the use of antibiotics in food-producing animals, which he argues is currently "rampant" and constitutes a public health problem.

In 2011, Kessler says, 80% of all antibiotics produced went to livestock animals, while the remainder went to human health care. The disparity is alarming, Kessler explained, but it also represents something of an improvement. That's because before the FDA Amendments Act of 2007, FDA didn't actually have the authority to require companies to inform the agency of the quantity of antibiotics sold for use in agriculture.

This isn't to say we know much about how antibiotics are prescribed. Case in point: FDA's latest report on antibiotic sales was just four pages, of which only one actually had the raw data, taking up about half of that page.

A Lack of Knowledge

But subsequent attempts to learn more about the industry have been difficult, Kessler alleges.

"We have more than enough scientific evidence to justify curbing the rampant use of antibiotics for livestock, yet the food and drug industries are not only fighting proposed legislation to reduce these practices, they also oppose collecting the data."

Those companies seem to have congressional support as well. Kessler points to the Senate's Health, Education, Labor and Pensions Committee, which recently finished work on the Animal Drug User Fee Act and Animal Generic Drug User Fee Act, both of which are intended to make changes to the way FDA regulates veterinary products.

Neither piece of legislation contains reforms to the way FDA treats veterinary antibiotics, Kessler said, despite public health experts urging the committee to require companies to submit more detailed antibiotic sales data to FDA.

"This information would be particularly valuable to the FDA, which asked drug makers last April to voluntarily stop selling antibiotics for these purposes," he added. "The agency has said it would mandate such action if those practices persisted, but it has no data to determine whether the voluntary policy is working."

Pointed Criticism of FDA

Not all of Kessler's ire is aimed at Congress and industry. He said his former agency, FDA, is guilty of "aiding and abetting" legislators' attempts to skirt the issue.

"The FDA stood by silently as the committee declined to act, rejecting a modest proposal from Senators Kirsten E. Gillibrand of New York and Dianne Feinstein of California, both Democrats, that required the agency to report data it already collects but does not disclose," he wrote.

And that lack of pressure has left some legislators more than willing to disengage from a tough but necessary fight, Kessler concluded.

"We cannot avoid tough questions because we're afraid of the answers. Lawmakers must let the public know how the drugs they need to stay well are being used to produce cheaper meat," he said.

FDA Response

In a response sent to Regulatory Focus, FDA's Siobhan DeLancey, veterinary medicine team lead, said FDA is committed to using the authority is has.

"The health of animals and people are undeniably interconnected in today's world. All uses of antimicrobial drugs, by humans and livestock producers, contribute to the development of antimicrobial resistance, an important public health concern," she explained. "These important drugs must be used judiciously to slow the development of resistance in both animal and human medicine.   FDA is committed to using its authority to enhance future summary reports under ADUFA section 105."

In addition, DeLancey said FDA is already working to address many concerns through an Advanced Notice of Public Rulemaking (ANPRM), which are used to solicit comments with the intent of issuing a regulation soon thereafter. That ANPRM is explicitly targeted at "the collection of antimicrobial drug sales/distribution data, including how FDA can best compile and present the annual summary information while still protecting confidential business information as directed by statute," DeLancey explained.

"FDA believes having additional information would lead to a better understanding of the extent to which medically important antimicrobial drugs are used  in food-producing animals and will support the agency's antimicrobial resistance strategy announced in April 2012," she added.


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