August 17, 2018 Update: The FDA is extending the comment period for the request for comments on the design of studies intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for the prevention of heartworm disease in dogs. The FDA is taking this action in response to requests for additional time to submit comments. The comment period will now close on November 20, 2018.
Additional information, including directions for filing comments, is available in the Federal Register Notice.
May 23, 2018 Original Notice Date: The Food and Drug Administration announced today that the Center for Veterinary Medicine (CVM) is evaluating the design of studies intended to support the standard of substantial evidence of effectiveness for new animal drugs to prevent heartworm disease in dogs. Currently, there are gaps in knowledge that prevent the FDA from fully evaluating which alternative approaches are suitable for meeting the standards of effectiveness. The need to evaluate alternative approaches is emphasized by the evolving susceptibility of Dirofilaria immitis larvae to heartworm preventatives containing macrocyclic lactones.
The current recommended approach is for sponsors to conduct two laboratory dose confirmation studies and one multisite field safety and effectiveness study under the principles of Good Clinical Practice (GCP) as described in Guidance for Industry #85, “Good Clinical Practice (VICH GL9).”
In recognition of the limitations of the current recommended laboratory and field effectiveness studies for heartworm preventatives for use in dogs, the FDA is looking towards evaluating alternative approaches to these study designs that would reduce the limitations of such studies while also ensuring that the studies generate data to support substantial evidence of effectiveness.
The FDA is requesting public input on possible alternate approaches for evaluating these products or information to assist in the potential development of alternative study designs. Specifically, the FDA is seeking public comment on the following topics:
- Defining an appropriate population-level effectiveness endpoint.
- Assessing exposure to infective Dirofilaria immitis larvae in a clinical setting.
- Outcome assessment for effectiveness.
The regulations electronic filing system will accept comments until midnight Eastern Time at the end of August 22, 2018. Please see the FR Notice for more information on how to submit comments.