Fort Dodge recall panel not yet named

Fort Dodge recall panel not yet named

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Nov 01, 2004
By dvm360.com staff

WASHINGTON—The Food and Drug Administration's (FDA) independent advisory council to evaluate Fort Dodge's Proheart 6 had yet to be named at presstime.

The FDA has requested that Fort Dodge Animal Health continue to conduct research "to determine the cause of related adverse reactions and develop a strategy to help prevent such problems in the future before the product is marketed again," reports FDA's Center for Veterinary Medicine (CVM) spokesperson Linda Grassie.

The agency refused further comment on how it planned to form the advisory committee to review safety data on the product.

As reported last month in DVM Newsmagazine, the manufacturer voluntarily recalled the product under the condition that an independent review evaluate FDA concerns about product safety.

At presstime, major questions remained unanswered, including the naming of the advisory panel and a timeline on when the panel will convene to address the fate of Proheart 6.

But any postulates circulating regarding FDA's next move is nothing more than "hallway talk", says Dr. Gatz Riddell, chairman of the American Veterinary Medical Association's Council of Biologic and Therapeutic Agents.

And the industry chatter goes something like this:

FDA might opt to coordinate the review from its existing Veterinary Medical Advisory Committee (VMAC) with the addition of a few new members. The reasoning might make sense, Riddell says, because FDA rules on forming independent advisory committees are very prescriptive. In other words, it might be easier for CVM to work within the VMAC structure in forming this panel than starting from scratch.