Regulatory Brief

 FDA Notice of Proposed Antiparasitic Drug and Resistance Survey


Formal Title: Docket Number (FDA-2010-N-0307); Agency Information Collection Activities; Proposed Collection; Comment Request; Antiparasitic Drug and Resistance Survey

Brief Description:

The U. S. Food and Drug Administration (FDA) proposes to survey members of veterinary professional organizations using an Internet-based survey instrument. The questions in the survey are designed to elicit professional opinions regarding the use of antiparasitic drugs and the awareness of antiparasitic drug resistance. The survey will query subjects on topics including:

  1. Awareness of the issues related to antiparasitic resistance,
  2. Methods currently being used to detect and/or monitor for antiparasitic resistance,
  3. Management practices being used or recommended to manage or reduce antiparasitic resistance, and
  4. Labeling and marketing considerations for antiparasitic drugs.

The FDA estimates that the survey will have 650 respondents, and invites public comments on the following topics pertaining to the survey.

  1. Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
  2. The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  3. Ways to enhance the quality, utility, and clarity of the information to be collected; and
  4. Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

AVMA Response:

Of the four specific questions about the survey for which the FDA seeks comments, the AVMA offers the following for numbers one and three. 

Topic 1:

Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility.

  1. No, the AVMA believes that the proposed collection of information is not necessary for the proper performance of FDA's functions. 
  2. While the AVMA agrees that assessing the current situation in the field is important, the information to be gained from the survey will have little practical utility because the data will be of opinions held by an extremely small sample size. 
  3. There are numerous variables involved in the field; thus, measuring resistance by observational methods has questionable validity.  Re-infestation is a significant confounder which could mimic resistance.  Resistance should be determined more scientifically, such as through a challenge model.
  4. Many antiparasitic drugs are available as OTC.  Inappropriate or inconsistent administration could produce a perceived resistance.
  5. FDA’s efforts regarding drug safety and efficacy are vital.  The survey could potentially yield a small glimpse of conditions in the field; however, the information to be gathered seems to be an ill fit with post-market surveillance as well as adverse event reporting. 
  6. Recommendations regarding the management or reduction of antiparasitic resistance are aspects of medical management and preventative herd health within the practice of veterinary medicine.  Such recommendations are based upon veterinary expertise combined with several factors including animal owner capabilities, animal species and health, and the parasitic risks.  The AVMA questions the FDA’s reasoning and intended regulatory use in gathering such information from respondents, especially since such recommendations are available in scientific literature.

Topic 3:

Ways to enhance the quality, utility, and clarity of the information to be collected.

  1. We suggest that if a survey is to be done, that it be redesigned so that while it may still gather opinions, it focuses on obtaining pertinent scientific information and more accurately targets respondents possessing the appropriate expertise on this particular subject.
  2. Incorporation of a scientific literature review may be beneficial in addressing some of the questions proposed.

Background Documents: