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U.S. Department of Health and Human Services

Animal & Veterinary

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Office of Surveillance and Compliance (OSC): VMAC Participation

By Shannon Cameron, Managing Editor, Communications

On March 24, 2010, four members of CVM’s Office of Surveillance & Compliance (OS&C) presented at the Veterinary Medicine Advisory Committee (VMAC) Public Meeting on ProHeart®6 in Rockville, MD.  ProHeart®6, an injectable heartworm preventive for dogs, was recalled in 2004 for safety concerns.  In June 2008, it was reintroduced under a Risk Minimization and Restricted Distribution Program, commonly known as a RiskMAP.

According to Ms. Janice Steinschneider, “RiskMAPs were developed to improve the risk/benefit ratio of drugs with special safety risks.  So, if you change the conditions of use, you can minimize some of the risks while maximizing the benefit[s].”

Presentations

Background by Dr. Daniel McChesney, Director, OS&C

Regulatory Framework by Ms. Janice Steinschneider, Regulatory Counsel, OS&C

Risk Maps and Labeling by Dr. Martine Hartogensis, Deputy Director, OS&C

Data Analysis by Dr. John Baker, Veterinary Medical Officer, OS&C

RiskMAPs are usually thought to restrict a veterinarian’s access to certain drugs, but Ms. Steinschneider explained that “looked at from a different point of view, RiskMAPs actually maintain access to drugs, because given the risk of these products, they might not otherwise be able to be marketed.  So in that sense, a RiskMAP actually increases access to drugs rather than decreasing it….”

The VMAC Public Meeting on ProHeart®6 was an opportunity for experts to comment on the effectiveness of RiskMAPs, veterinarians to comment on how RiskMAPs affect their practices, and members of the public to comment on how RiskMAPs impact them. 

For the complete transcript of the ProHeart®6 VMAC meeting, or for other 2010 VMAC Meeting Materials, go to http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ VeterinaryMedicineAdvisoryCommittee/ucm201810.htm