Stakeholders in the animal health and feed industries have
spent the better part of two years reviewing the proposed changes to the Food & Drug Administration’s (FDA) Veterinary
Feed Directive (VFD). While many of their concerns were addressed, there remain
a few areas that will complicate its implementation by January 2017.
Of these problem areas, one major point of contention was
the required two-year VFD recordkeeping guideline. I spoke to Richard Sellers,
AFIA’s senior vice president of regulatory affairs, shortly after the final
rule was released in early June. Sellers reports that he was of the belief that
the recordkeeping timeline had been reduced to one year and was a bit taken
aback when it remained unchanged.
“We believed we had convinced FDA the two-year requirement
should be reduced to one year to agree with the one-year recordkeeping
requirement that appears in the Current Good Manufacturing Practices
regulations,” he said.
According to Sellers, the two-year requirement poses a
challenge because none of the U.S. feed mills are currently utilizing a
validated electronic system due to the high cost. Instead, each of the
thousands of feed mills using medicated feeds will end up retaining signed and
dated hardcopies of each VFD for two years. This may not seem like a huge
inconvenience at first, but when you consider the additional 283 drugs gaining
VDF status, holding onto paperwork for two years at a time presents a great
administrative burden and, frankly, take up a lot of space.
To date, it’s unclear if this portion of the rule will
amended.
Another prevailing question: Will there be enough
veterinarians available to prescribe the VFD drugs?
“It will require a lot of veterinary work to authorize the
use of what had been over-the-counter drugs,” Sellers explained. “Where are
they going to be trained? Where are they going to come from? It’s a major
marketplace concern.”
Sellers also mentioned the potential problem of “dual drugs
on marketplace.” Specifically, the existence of outstanding products with
growth promotion claims that may still be in circulation when the VFD goes into
effect.
To gauge the stocks, Sellers mentioned that AFIA plans to
send out a survey later this year to learn about more about the label changes
its members have made; the estimated quantity of product with growth promotion
claims remaining on market; the dollar value of this outstanding stock; and how
long they believe it will take to eliminate those supplies.
AFIA will hosting two webinars addressing VFD questions
beginning on June 30. For more information, click here.
