A data quality petition filed December 6, 2002 by the Animal Health Institute (AHI) challenged information the Centers for Disease Control and Prevention (CDC) disseminates regarding fluoroquinolones. Background Fluoroquinolones are a class of antibiotics used on humans, pets, and more recently poultry. The Centers for Disease Control (CDC) opposed the use of fluoroquinolone in poultry, but the Food and Drug Administration (FDA) approved two drugs -- one developed by Abbott Laboratories (approved in 1995) and another by the Bayer Corporation (approved in 1996). CDC believes that use of fluoroquinolones in poultry creates antibiotic-resistant food borne bacteria, making it harder to treat people infected from eating undercooked poultry with illnesses such as campylobacteriosis. In 2000, FDA's Center for Veterinary Medicine (CVM) proposed withdrawing approval for the Bayer fluoroquinolone, enrofloxacin, for use in poultry. Bayer filed a request for a hearing, which took place earlier this year, and the proposed withdrawal is awaiting a judge's decision. Abbott Laboratories voluntarily requested withdrawal of its drug application in 2001 for its fluoroquinolone, sarafloxacin hydrochloride. AHI filed a related data quality petition with the FDA Jan. 22 that challenged a risk assessment of the human health impacts from fluoroquinolone resistant bacteria (Camplylobacter). AHI asserts that the risk assessment does not use the best available science and supporting studies, uses data collected by unacceptable methods, does not ensure that the information is comprehensive, and does not explain why additional studies were not used in developing the risk estimate produced from the assessment. AHI appears to be using the Data Quality Act to disqualify information on fluoroquinolones in the event the court supports the withdrawal proposal. If AHI's data quality challenge undermines the evidence supporting CVM's proposal, then the organization might overturn the withdrawal through a separate avenue. Request for Correction AHI, a trade organization for developers and manufacturers of animal drugs and biological products including the Bayer Corporation, asserted that since approval in 1995 CDC has pushed for FDA to withdraw approval for fluoroquinolone in poultry. AHI believes CDC has violated its data quality guidelines by disseminated statements that rely on unpublished and/or preliminary data and flawed literature. AHI contends that the following statements are erroneous:

• A person infected with a fluoroquinolone resistant bacteria will face a longer illness than if it is non-resistant bacteria.
• The percentage of resistant bacteria from people in the U.S. is dramatically rising.
• There are 2.4 million annual cases of campylobacteriosis in the U.S.

AHI notes that at least 11 presentation and abstracts disseminated on the CDC website contain these statements. To correct the information, AHI recommends that CDC:

• Remove or correct the statements in the documents and apply this to future information.
• Stop making statements about antibiotic resistance that are based on incomplete or preliminary data.
• Make any information supporting public statement regarding antibiotic resistance available to the public for review.
• Refrain from discussing the National Antimicrobial Resistance Monitoring System (NARMS) without identifying the limitations in the data.
• Issue a corrective statement that designates the erroneous information identified in this challenge on CDC's website, other places where the information is disseminated, and on every archival document that references the corrected information.

Agency Response CDC denied the petition March 13, stating that the challenged information does not misrepresent available data and is consistent with agency guidelines. The agency maintains that the clinical laboratories, which provide the bacterial infectious disease surveillance data, have established quality control procedures. Additionally, CDC experts review the information for medical, scientific and public health accuracy. CDC also notes that several pieces of information cited in AHI's complaint are not subject to data quality guidelines because of the agency was not the source; four of the documents were articles from media sources such as the Wall Street Journal. The agency also provided a detailed explanation for each of the statements AHI questioned. However, the agency agreed that presentations should clearly identify preliminary data and committed to discuss limitations in NARMS and fluoroquinolone data in future materials. AHI Request for Reconsideration In a March 27 appeal, AHI presented additional information to strengthen its original arguments and requested a meeting with CDC to discuss the data quality challenge. AHI asserts that the additional information proves the data that CDC used to make statements about fluoroquinolone contained flaws that the agency failed to recognize. AHI also claims that although four of the documents it cited as flawed are from the media, the guidelines cover quotations from CDC staff that appear in the news sources. However, in the HHS data quality guidelines, the definition of "dissemination" covers only "agency initiated or sponsored distribution of information to the public" and it is doubtful that newspaper articles are agency initiated. Agency Response to the Appeal CDC denied all the arguments in the request for reconsideration again stating that the agency believes the information correctly represents the available data. As in the original response, the July 11 letter affirms that CDC will clearly identify information as preliminary when included in presentations and future statements will explain if reliable information is not available.