Agency Implementing Plan To Ensure Judicious Use Of Antibiotics In Food
U.S. Food and Drug Administration TODAY
is implementing a plan to help phase out the use of medically important
antimicrobials in food animals for food production purposes, such as to enhance
growth or improve feed efficiency. The plan would also phase in veterinary
oversight of the remaining appropriate therapeutic uses of such drugs.
antimicrobials have historically been used in the feed or drinking water of
cattle, poultry, hogs, and other food animals for production purposes such as
using less food to gain weight. Some of these antimicrobials are important
drugs used to treat human infection, prompting concerns about the contribution
of this practice to increasing the ability of bacteria and other microbes to
resist the effects of a drug. Once antimicrobial resistance occurs, a drug may
no longer be as effective in treating various illnesses or infections.
antimicrobial drug use in both humans and animals can contribute to the
development of antimicrobial resistance, it is important to use these drugs
only when medically necessary. The plan announced today focuses on those
antimicrobial drugs that are considered medically important (i.e., are
important for treating human infection) and which are approved for use in feed
and water of food animals.
final guidance issued TODAY, the FDA
lays out a road map for animal pharmaceutical companies to voluntarily revise
the FDA-approved use conditions on the labels of these products to remove
plan also calls for changing the current over-the-counter (OTC) status to bring
the remaining appropriate therapeutic uses under veterinary oversight. Once a manufacturer
voluntarily makes these changes, its medically important antimicrobial drugs
can no longer be used for production purposes, and their use to treat, control,
or prevent disease in animals will require veterinary oversight.
FDA is asking animal pharmaceutical companies to notify the agency of their
intent to sign on to the strategy within the next three months. These companies
would then have a three-year transition process.
this strategy is an important step forward in addressing antimicrobial
resistance. The FDA is leveraging the cooperation of the pharmaceutical
industry to voluntarily make these changes because we believe this approach is
the fastest way to achieve our goal,” said FDA Deputy Commissioner for Foods
and Veterinary Medicine Michael Taylor.
“Based on our outreach, we have every reason to believe that animal
pharmaceutical companies will support us in this effort.”
order to help phase in veterinary oversight of those drugs covered by the
guidance that are intended for medically appropriate uses in feed, the FDA also
has issued a proposed rule to update the existing regulations relating to
Veterinary Feed Directive (VFD) drugs. The use of VFD drugs requires specific
authorization by a licensed veterinarian using a process outlined in the
agency’s VFD regulations. The VFD proposed rule is intended to update the
existing VFD process and facilitate expanded veterinary oversight by clarifying
and increasing the flexibility of the administrative requirements for the distribution
and use of VFD drugs. Such updates to the VFD process will assist in the
transition of OTC products to their new VFD status.
action promotes the judicious use of important antimicrobials to protect public
health while ensuring that sick and at-risk animals receive the therapy they
need,” said Bernadette Dunham, DVM,
Ph.D., director of the FDA’s Center for Veterinary Medicine. “We realize that
these steps represent changes for veterinarians and animal producers, and we
have been working -- and will continue to work -- to make this transition as
seamless as possible.”
guidance for animal pharmaceutical companies is now in final form, and the
proposed VFD rule is open for public comment for 90 days starting tomorrow,
Dec. 12, 2013. To electronically submit comments on the proposed VFD rule, go
to www.regulations.gov and insert
docket FDA-2010-N-0155. Send written comments to the Division of Dockets
Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane,
Rockville, MD 20852.
Labels: Agency Implementing Plan to Ensure Judicious Use of Antibiotics in Food Animals, Antimicrobials in livestock, FDA Addresses Antimicrobial Resistance