Regulatory Brief

 Sample Collection Plan for Dogs Treated with Slentrol

Formal title: Docket Number [FDA-2010-N-0358] Agency Information Collection Activities; Proposed Collection; Comment Request; Sample Collection Plan for Dogs Treated with SLENTROL

The Food and Drug Administration (FDA) provided an opportunity for public comment on the proposed collection of certain information by the agency.

Brief Description:

Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the sample collection plan for dogs treated with the drug Slentrol.

FDA's Center for Veterinary Medicine (CVM) is planning a pharmacogenomic study to examine whether adverse drug events (ADEs) experienced with Slentrol, an anti-obesity drug approved for dogs, are associated with genetic variations in the dogs treated.

AVMA Response:

The AVMA supports the advancement of medical knowledge and robust adverse event reporting (AER) systems. However, considering the critical nature of other AER needs, the AVMA is not convinced that the FDA's performance of this highly technical research on Slentrol would be resources well spent. The AVMA also has concerns about the value of the information that will be obtained from the study. At this time, genetic testing of dogs before treating them is not practical and the AVMA feels it is important that FDA explain clearly why this particular drug was selected for the testing.

Background Documents:

View Federal Register document. (PDF)

Status:

The AVMA responded on September 27, 2010. (PDF)