Organization Submits Second Data Quality Challenge on Antibiotics for Poultry
by Guest Blogger, 12/10/2003
The Animal Health Institute (AHI) filed a data quality petition January 22, 2003 to the Food and Drug Administration (FDA) challenging a risk assessment of the human health impacts from fluoroquinolone resistant bacteria (Camplylobacter). 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 CDC December 6, 2002 that challenged statements the agency made on human illness related to fluoroquinolone resistant bacteria, the percentage of resistant bacteria in humans, and the number of annual cases of campylobacteriosis in the U.S. 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 The petition challenges the Campylobacter risk assessment referred to as the "Vose Rick Assessment", which became available on CVM's website in January 2001. AHI asserts that because the document has been widely relied upon, referenced, and disseminated by the CVM, CDC and others it is subject to the FDA's data quality guidelines. The petitioner contends the risk assessment contains several flaws and does not meet the data quality standards of utility, objectivity and integrity because:
- It does not use the best available science and supporting studies including peer reviewed studies.
- It uses data collected by unacceptable methods.
- It does not ensure that the information is comprehensive.
- It does not explain why additional studies were not used in developing the risk estimate produced from the assessment.
- Appoint a qualified and independent risk assessment expert to evaluate the Vose Risk Assessment model and the issues the petition has raised.
- Stop disseminating the risk assessment if the expert review confirms that the assessment does not comply with FDA data quality guidelines and have a qualified and independent expert group fully review the assessment if the review disproves the complaints.
- Stop CVM from disseminating the underlying data if it is found out of compliance with FDA guidelines.
- Prompt CVM to issue a corrective statement on its website, in other points of dissemination, and on archival documents that reference the information explaining it is erroneous.
- AHI believes the improper person responded to the request, as the guidelines state that the supervisor of the employee that made the decision in question should review the challenge.
- CVM's deferral of its decision until after the conclusion of the hearing violates the Administrative Procedure Act.
- The organization asserts that the data quality aspects of the risk assessment are not being considered in the court hearing and cites CVM's statement in the hearing that the judge disregard the FDA guidelines.
- AHI contends that a review of its request will not disrupt the hearing or waste agency resources.
- CVM's choice to wait until after the hearing eliminates AHI's only opportunity to correct the information before the hearing is over, and allows the information to be used to support withdrawal of the drug approval.
- AHI restates its belief that the risk assessment does not meet the OMB, HHS, or FDA's data quality guidelines.