FDA defers to vet’s ‘clinical judgement’ to link health problems to VFD product’s indications

FDA will defer to the expertise of veterinarians to diagnose health conditions requiring veterinary feed directive (VFD) medications, but the agency still expects usage to comply with the product labels, according to an FDA veterinarian.

“There is a legal obligation to use the product on label,” William Flynn, DVM, MS, deputy director for science policy at FDA’s Center for Veterinary Medicine, said in an interview with the VFD News Center .

However, he added, “It’s not as though we’re saying a veterinarian is obligated to get more diagnostics if their clinical judgment leads them to believe this is the appropriate product to use.”

He offered a cattle industry example to make his point but said the spirit of it was applicable to all food animal species.

“You may have Product A that’s approved for respiratory disease in cattle and Product B that’s approved for foot rot but not for respiratory disease,” he said.  “If [veterinarians are] making a diagnosis of respiratory disease, then obviously, they need to be reaching for and authorizing the use of a product that has a respiratory disease on the label. They can’t authorize a product that only has a foot rot claim for treatment of respiratory disease.”

So, if there’s a respiratory disease in a flock or herd and there’s a particular antibiotic the veterinarian feels will be effective and it at least has one respiratory claim, can the veterinarian in his or her clinical judgment and experience feel confident issuing a VFD for that product?

“Yes, that’s accurate,” Flynn told editors of the VFD News Center .

“Labels on these products are sometimes more specific and sometimes not,” he continued.  “Some may specify respiratory disease associated with bacteria X, Y or Z. The veterinarian may not have confirmed diagnostics that prove its bacteria X, Y or Z, but if the clinical syndrome is one they feel, based on experience, is consistent with that respiratory disease and the history suggests it’s often associated with one of those bacteria, then, yes — I think that would be acceptable.”

The same holds true for water-soluble antibiotics, though veterinarians have a little more flexibility with these medications.

“Our thinking would be the same in terms of veterinarians using their clinical judgment when‎ diagnosing disease and determining the appropriate treatment,” Flynn explained.  “However, there is more latitude legally regarding a scenario that involves a water-soluble antibiotic product. Current law permits a veterinarian to prescribe (under certain conditions) that a water-soluble product be used in an extra-label manner, but extra-label use of drugs in or on animal feed is not permitted.”

Click here for the full interview.