AFIA Surprised by VFD Recordkeeping Requirements; Gives Insight on Antibiotic Stewardship Program

June 3, 2015 01:52 PM
 
AFIA Surprised by VFD Recordkeeping Requirements; Gives Insight on Antibiotic Stewardship Program

Richard Sellers, American Feed Industry Association senior vice president of legislative and regulatory affairs, joined animal and health industry stakeholders Tuesday at the "White House Forum on Antibiotic Stewardship" hosted by the Obama Administration. The forum brought together key constituencies involved with the National Antibiotic Stewardship Program and announced the groups' commitment to implement changes and education during the next five years in an effort to combat antibiotic resistance.

"AFIA and the feed industry have been committed from the very inception of the Veterinary Feed Directive as the feed manufacturers have an important role in delivering safe medicated feed to the livestock producer. As the role of VFD expands, our commitment only strengthens," said Sellers.

During the meeting, a major government rulemaking came to fruition. The U.S. Food and Drug Administration released the final VFD rule--a large piece of FDA's plan to promote judicious use of medically important antibiotics in food-producing animals. The regulations revise the requirements for a VFD from a licensed veterinarian for medications and the responsibilities of the feed manufacturer when fulfilling the VFD.

"AFIA was a principal author of the original VFD provision in the Animal Drug Availability Act of 1996 and I have seen it come from its roots in 1995 to the announcement made at the White House today," said Sellers following the event. "The final rule shows many improvements for the industry that will make the process more effective and timely."

"At 100-plus pages, we have much to review, but at first glance we noticed the recordkeeping timeline is still a two-year requirement," Sellers said. "That's a concern, as 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 (Title 21, C.F.R., Part 225)."

Sellers also noted the White House announcement Tuesday of a new plan to buy food for federal agencies from sources that utilize responsible antibiotic-use policies is "premature given FDA's judicious-use antibiotic policy doesn't go into full effect until December 2016, when animal drug sponsors remove production claims from approved animal drugs." 

"The memorandum announced yesterday sends the wrong message to both our trading partners and consumers," said Sellers. "It also focuses in on hormone-free products--which have not previously been part of the antibiotic discussion--and appears to imply hormone-free products are safer and should be preferred by consumers because the federal government, including our president, use them. However, FDA has made no announcements regarding any safety concerns about hormones approved for use in animals."

AFIA will evaluate the final rule and continue to work with AFIA members to implement the changes appropriately in the timeframe provided.

AFIA, with partners Feedstuffs and Elanco Animal Health, will host a webinar detailing the changes in the VFD final rule in the very near future. FDA has been invited to participate in the online event.

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