The U.S. Food and Drug Administration is seeking public comment on the sample collection plan for dogs treated with the drug Slentrol, an anti-obesity drug approved for dogs.
The deadline to comment is Monday, Sept. 27, 2010.
The plan includes a pharmacogenomic study to examine whether adverse drug events experienced with Slentrol are associated with genetic variations in the dogs treated. Preliminary analysis by the FDA’s Center for Veterinary Medicine (CVM) has indicated potential correlations between dog breeds and some adverse drug events.
The study would collect a blood sample and buccal swab from animals that have been treated with Slentrol and experienced specific adverse drug events (i.e. reactors) and animals that have been treated with Slentrol and that have not experienced adverse drug events (i.e. controls).
The samples would be analyzed by the FDA using microarray analysis and single nucleotide polymorphism analysis to determine possible genetic variations associated with the adverse drug events reported.
If this project identifies definite genotype mutations associated with drug response, CVM would potentially have a scientific basis for modifying recommendations with regard to Slentrol use, according to the FDA.
The FDA reported that its goal is to obtain about 100 samples.
To conduct the study, the FDA would seek voluntary participation of veterinarians in the private sector. The FDA would contact veterinarians who have reported adverse events with Slentrol to the FDA or veterinarians who have posted adverse experiences with Slentrol on websites or other public forums with their contact information.
If the veterinarians are willing to participate, and the owners of animals consent, the FDA would provide the veterinarian with a “Sample Collection” pack, which would include instructions and related materials.
In addition to obtaining the sample, the veterinarian would need to fill out a form that includes information about the treated dog (breed, age, gender, neuter status and type of food) and information about past Slentrol use and adverse events experienced.
The FDA noted that it anticipates that participating veterinarians will take the samples during routine office visits from pet owners for their pets, and that pet owners will not make a special trip to the veterinarian for the purpose of the study.
The FDA estimates that it will take a veterinarian about 30 minutes to obtain the owner’s consent, take the blood and buccal samples and fill out the “Sample Collection” form.
The FDA invites comments on the following topics:
- Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;.
- The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;.
- Ways to enhance the quality, utility and clarity of the information to be collected; and.
- 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.
Click here to view the proposal and search for docket number 2010–N–0358.
Comments may be submitted electronically via www.regulations.gov or by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with the docket number 2010–N–0358.