In September 2006, the FDA convened its Veterinary Medicine Advisory Committee (VMAC) to consider the application by drug maker Intervet of its new animal drug Cefquinome. Cefquinome, proposed for use to treat respiratory disease in cattle, is a 4th generation cephalosporin, a class which includes the important human drug cefepime.

KAW provided testimony showing that approval of cefquinome would threaten public health, as did the Union of Concerned Scientists, the American Medical Association and the Infectious Diseases Society of America (read the comments submitted by KAW, UCS, IDSA, and AMA). In the end, the VMAC rejected Intervet's claim that cefquinome could be considered safe for human health (meeting transcript and KAW's news release).

In spite of VMAC’s decision, Intervet continued to pursue approval of cefquinome by not withdrawing its application. To counter industry momentum, KAW wrote a letter to FDA urging the agency to heed the advice of its advisory committee, to which the agency replied that it was still considering the evidence (KAW news release). In addition, in January 2007, KAW sent a second letter to FDA about two recently published European studies that reported widespread resistance to drugs in the same class as cefquinome on farms. Moreover, that same month Rep. Louise Slaughter wrote to FDA and urged the agency not to approve cefquinome (KAW's news release).

In March 2007, the Washington Post published a front page story on the pending approval of cefquinome. This story led to numerous news and opinion pieces in newspapers and TV programs across the country (full list).

Prominent medical groups also weighed in: AMA, APHA, IDSA, AAP and APUA wrote to the FDA and urged the agency to act in the interest of public health and not approve cefquinome. Michael Feldgarden of APUA recently wrote in Microbe Magazine about the importance of considering all the possible consequences before approving a new antibiotic.

In May 2007, KAW member groups sent a letter to drug manufacturer Intervet and called on the company to withdraw its application for approval (news release). Schering-Plough, which is to acquire Intervet, sent a response stating that Schering-Plough is "not yet analyzing or commenting on issues surrounding the Intervet products." In addition, Bon Appetit, a major leading food service company, sent a letter to FDA opposing cefquinome, citing the company's commitment to socially responsible business practices.

Intervet responded via letter in June stating that the company "disagrees with KAW's conclusions and believes the current scientific data adequately supports [sic] approval of the (cefquinome) application under the standards established by the FDA."

Most recently, KAW member organizations sent a letter to FDA Commissioner Von Eschenbach, which detailed the emergence of cephalosporin-resistant bacteria in the United States--a problem that would only be exacerbated by the approval of cefquinome for use in cattle. FDA produced the following response. However, in July 2008, partly due to KAW’s continuing insistence on the need to safeguard cephalosporins for use in human medicine, the FDA banned the extralabel use of 3rd and 4th generation cephalosporins in food animals. KAW applauded this move as a good step in the right direction, but not enough to keep these important drugs effective for use in human medicine. Unfortunately, a few months later, the FDA reversed its decision to ban the extralabel use of cephalosporin antimicrobial drugs in veterinary medicine. This move came after the Agency received over 300 comments from the animal agriculture industry and production veterinarians. KAW decried this move and continues to press FDA to enact the ban, which was supported by ample scientific evidence.

As for cefquinome, the drug remains unapproved as of early 2009. Since Intervet officially has been acquired by Schering-Plough, the company Intervet/Schering-Plough can now analyze and comment on the issues surrounding the cefquinome application. To that end, KAW has sent Schering-Plough a letter calling for a withdrawal of the company's new animal drug application for cefquinome. Considering the risks to public health involved in using cephalosporins in this manner, the time is ripe for the FDA to reject Intervet/Schering-Plough's application for cefquinome and to enact the extralabel ban on cephalosporins in food animals.