The National Grain and Feed Association said Friday that the U.S. Food and Drug Administration's changes to phase out the use of certain "medically important" antibiotics in animals is welcome, but additional improvements are suggested.
FDA in December announced the policy, which phases out use of certain antimicrobials – some of which are administered in feed. At the same time, the policy would phase in veterinary oversight, or veterinary feed directive standards, for the use of therapeutic antimicrobials. It is anticipated that this transition will occur by the end of 2016.
NGFA issued its opinion in a letter to the agency, commending FDA for incorporating many of the organization's previous recommendations to streamline and make more efficient the agency's current VFD process.
NGFA's letter said its recommendations "would make substantial and meaningful improvements to the VFD process if retained in final regulations."
The group also commended the agency for its approach to crafting and soliciting additional public comment before "proceeding to proposed regulations, given the significance of the regulatory issues involved."
NGFA's statement recommends that FDA:
• Require veterinarians to take and pass a training program – preferably available electronically – before being authorized to issue a lawful VFD. NGFA says it believes this will eliminate confusion and errors that have occurred within the existing VFD process.
• Create a list of VFD-trained veterinarians to be made available on a publicly accessible website hosted by a professional society or by FDA itself.
• Improve the information collected on the VFD form itself to be more "appropriate and relevant" to the manufacturing of medicated feed, including by eliminating the requirement that the VFD form contain a specific quantity of feed to be manufactured per order, which can vary based upon weather and other factors that affect feed consumption by animals.
NGFA previously had noted that other information already required on the VFD form, such as the duration of treatment, level of animal drug allowed in the feed, feeding directions and expiration date, already provided sufficient information so that the appropriate quantity of feed is manufactured, distributed and fed to the target animals.
• Further clarify that VFD orders under the agency's proposed amendments may be transmitted and stored with electronic systems that need not be compliant with the agency's "costly and onerous electronic records/electronic signatures requirements."
"The NGFA for several years has advocated improvements to the VFD process – even though it currently is applied to a limited number of animal drugs products used in food-producing animals," the statement said. "Importantly in this regard, medicated feed manufacturers who use existing VFD animal drugs already bear the primary regulatory burden associated with administering these drugs. This regulatory burden is substantial, both in terms of time and cost, with feed mills being the focal point for inspection when regulatory officials seek to determine compliance with the VFD regulations."
The letter continues, "given FDA's decision to expand the use of the VFD process to encompass many currently approved animal drugs, feed manufacturers will experience a significant increase in paperwork burdens and regulatory compliance costs if long-overdue improvements are not made."
As such, according to its letter, "the NGFA believes it is essential to modify the VFD process to make it as efficient and cost-effective as possible, while retaining prudent regulatory control to foster animal and human health."
Animal pharmaceutical companies weigh in
The Animal Health Institute and the Generic Animal Drug Alliance, representing animal pharmaceutical companies, said earlier this month that they would support the FDA's plan.
Like NGFA, the groups said they appreciated FDA's efforts to work with stakeholders in the discussion.