FDA's VMAC to look at risk minimization program of ProHeart 6

Jan 29, 2010
By dvm360.com staff
Rockville, Md. -- The Food and Drug Administration reports its Veterinary Medicine Advisory Committee (VMAC) will meet to talk about new data from its risk minimization plan regarding Pfizer's ProHeart 6.
The VMAC meeting is slated from 8:30 a.m. to 5 p.m. on March 24 at the Rockville Hilton.

The first 18 months of data generated from the agency's Risk Minimization Action Plan (RiskMAP) will be presented. Moxidectin was reintroduced to the veterinary market in 2008, following a controversial FDA decision to remove it from the market in 2005 because of safety concerns.

"The purpose of the RiskMAP," FDA explains, "is to ensure safe and appropriate use of ProHeart® 6 in order to achieve the maximum benefits of heartworm prevention while minimizing the risk to dogs. CVM will be presenting the results of our analysis of 18 months of data generated under the RiskMAP and are seeking feedback from the expert panel," the agency reports in a prepared statement. The meeting is open to the public. Interested persons may present data, information or views, orally or in writing. Written submissions may be made to Aleta Sindelar, CVM (HFV-3), FDA, 7519 Standish Place, Rockville, MD 20855 by March 17.

Oral presentations from the public are scheduled from 1-2 p.m. on March 24. Those individuals interested in making a presentation should contact Aleta Sindelar by March 9 and submit a brief statement of the general nature of the evidence or arguments, the names and addresses of proposed participants, and an indication of the approximate time requested to make the presentation.