FDA issues draft guidance on VFD common format

The U.S. Food and Drug Administration has issued draft guidance for industry (GFI #233) titled, “Veterinary Feed Directive Common Format Questions and Answers” to provide animal drug sponsors who are seeking approval for use of their drug in or on animal feed as a veterinary feed directive (VFD) drug with a recommended common format for a fillable form -- called a VFD -- that can later be used by veterinarians to authorize the use of the sponsor’s drug in feed.
The draft guidance describes the requirements for sponsor submission of a VFD to FDA as part of the application process for approval of a new animal drug for use in or on animal feed as a VFD drug, as well as the required and optional information to be included on the VFD. The draft guidance also provides examples that illustrate how a common VFD format might appear and how some of the information on the VFD may be pre-populated by a sponsor. By recommending a common format, the draft guidance is expected to help veterinarians, distributors (including feed mills), and animal producers quickly identify relevant information on a VFD order. A common format is also expected to reduce the risk of a veterinarian making an error or leaving out required information when filling in the form.
Guidance documents represent the FDA’s current thinking on particular topics, policies and regulatory issues. While “guidance for industry” documents are prepared primarily for industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of laws and policies.
The FDA is accepting public comments beginning on December 1, 2015. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2010-N-0155 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close 60 days after it publishes in the Federal Register. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final guidance.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2010-N-0155 on each page of your written comments.

AFIA comments on Veterinary Feed Directive final rule

Richard Sellers, American Feed Industry Association (AFIA) 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, 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 after 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."
Sellers also noted the White House announcement 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.

FDA releases Veterinary Feed Directive final rule

The U.S. Food and Drug Administration (FDA) on June 2 announced the Veterinary Feed Directive (VFD) final rule, an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals.
This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health. The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes.
The VFD final rule continues to require veterinarians to issue all VFDs within the context of a veterinarian-client-patient relationship (VCPR) and specifies the key elements that define a VCPR. These key elements include that the veterinarian engage with the client (i.e. animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e. animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care. The final rule will require veterinarians to follow state-defined VCPR requirements; in states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements. All veterinarians will need to adhere to a VCPR that includes the key elements in the final rule.
“The actions the FDA has taken to date represent important steps toward a fundamental change in how antimicrobials can be legally used in food-producing animals,” said Michael R. Taylor, FDA deputy commissioner for foods. “The VFD final rule takes another important step by facilitating veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while ensuring such oversight is conducted in accordance with nationally consistent principles.”
In December 2013, the agency published a guidance document, which calls on animal drug manufacturers of approved medically important antimicrobials that are put into water or feed of food-producing animals to voluntarily stop labeling them as drugs that can be used to promote animal growth and change the labeling of their products for the remaining uses to require veterinary oversight of these drugs when they are used for therapeutic purposes. All of the affected makers of these drugs have committed in writing to participate in the strategy.

US swine producers prepare for VFD final rule implementation

Andrea Gantz
Dr. Ron Prestage, NPPC president, addresses the media at the 2015 World Pork Expo. 
The Food and Drug Administration’s (FDA) Veterinary Feed Directive (VFD) final rule took centerstage at the National Pork Producers Council’s (NPPC) opening press conference at the 2015 World Pork Expo. 
The final rule, announced June 2, provides the framework to promote the judicious use of antimicrobials in food-producing animals by eliminating the use of medically important antibiotics for growth promotion and bringing therapeutic treatment under veterinary oversight.
According to NPPC president Dr. Ron Prestage, the swine industry fully embraces the change.
“We recognize the need to protect the availability of medically important antibiotics for animal and human medicine,” says Dr. Ron Prestage, NPPC president, who notes the organization’s 16-year push to reduce antibiotic use in pork production. “I’ve said it before and I’ll say it again: Those of us working in agriculture will never win nor would it be prudent to point the finger at our human counterparts’ positions in an effort to defend our use of antibiotics.”
Under the VFD final rule, antibiotics that formerly held over-the-counter status will now require a veterinarian’s prescription before they can be used in animal feed and water. This action adds an additional 283 drugs to the VFD list. In addition, it will require additional veterinarian oversight and accountability as defined by the veterinarian-client-patient relationship (VCPR) criteria. The final rule will be implemented by the end of 2016.
Animal health remains a priority
Prestage points to yesterday’s “White House Forum on Antibiotic Stewardship," a gathering of more than 100 animal and health stakeholders hosted by the Obama administration, aimed at cooperatively tackling the global issue of antimicrobial resistance.
“No one questioned that as ethical caretakers of animals we have a moral obligation to treat animals if they’re sick,” Prestage reports. “The good news is they all recognized that we need to treat animals if they become ill.” 
He stresses that antimicrobial resistance is the “big issue” and wants pork industry customers to understand that safeguards are in place to ensure responsible antibiotic use in pig farming. 
NPPC promotes responsible antibiotic
The NPPC notes that the organizations efforts to curb the overuse of antibiotics began in 1999 with Pork Quality Assurance (PQA) Plus, a management education program run by Pork Checkoff “that emphasizes good management practices in the handling and use of animal health products, and encourages producers to review their approach to their herd’s health problems.”
The three-prong program focuses animal health, animal welfare and environmental stewardship.
“Within animal health, we focus on the appropriate and judicious use of antibiotics and that there needs to be an appropriate VCPR in order to make the appropriate decisions involving antibiotics,” says Prestage.  “It’s not the result of recent attention to antibiotics in food animals, this has been evolving for the last 16 years within the leadership of NPPC.” 
The World Pork Expo will be held in Des Moines, IA, June 3-5, 2015.
For more information, visit www.pork.org.

Veterinary Feed Directive should improve public perception of antibiotic use in the food chain

The Veterinary Feed Directive, including upcoming regulatory changes, should have a positive impact on public perception of antibiotic use in the food chain. 
A recent panel discussion, "The future of antibiotics in poultry: The role of the Veterinary Feed Directive," presented by WATTAgNet.com and sponsored by Zoetis, examined the role of the Veterinary Feed Directive in meeting the expectations of the public and addressed the directive's proposed changes and their effects on the poultry industry. You can view the entire 90-minute panel discussion in five segments, starting with part one. 
Veterinary Feed Directive regulations outline the requirements for the sale and distribution of a product designated as a VFD drug, as well as the obligations of a veterinarian issuing the order of a drug in terms of what information must be included on the order. The regulations also specify the requirements for record keeping by all parties, including feed mills filling drug orders and others in the feed industry. According to Dr. William Flynn, deputy director for science policy at the Food and Drug Administration’s Center for Veterinary Medicine, the FDA CVM is looking to streamline the process so it's as efficient as possible, because more products will be joining the VFD designation. "Our vision is that a number of products now that are available over the counter will be gradually phased in from their over-the-counter status to this VFD status," said Flynn. 
This expansion of VFD status drugs will increase public confidence in the use of antibiotics by bringing veterinarians more firmly into the process. "Zoetis research has shown that the veterinarian is very trusted by the public," said Dr. Stephen Sutherland, DVM, senior director of regulatory affairs at Zoetis. "They have a tremendous amount of confidence in the veterinary profession. And if they know that the veterinarian's involved in the use of these antibiotics and the decision-making process, it's going to increase their confidence in how these products are used in the marketplace and in the food supply."

Veterinary feed directive revision a priority for 2013, says CVM director

Dr. Bernadette Dunham, director, US Food and Drug Administration, Center for Veterinary Medicine, addressed the National Turkey Federation’s annual convention electronically and said that all uses of antibiotics can be a driver of resistance.
Antibiotic use in human and veterinary medicine as well as use in horticulture and other industries. She explained that in 2013 finalizing both a revision to the Veterinary Feed Directive and the Draft Guidance for Industry 213, regarding use of antimicrobials with importance to human medicine in food producing animals, are both priorities for FDA. “We hope to move forward on both documents concurrently,” she said.
“FDA believes a proactive and collaborative strategy is the best approach as this provides a path forward for addressing public health concern in a manner that takes into account animal health needs and impacts on animal agriculture,” Dunham said. “While there are gaps in our understanding, the science continues to evolve.”
Dunham said that the National Antimicrobial Resistance Monitoring System (NARMS), which was initiated in 1996, has provided data that has been used in FDA’s decision making regarding drug approvals. FDA CVM has prohibited extra label use in food producing animals for flouroquinolones and glycopeptides. In 2003, FDA released Guidance for Industry 152, which established a framework for assessing antimicrobial resistance risks as part of the new drug approval.
Judicious use of antimicrobials focuses is on initiating steps to assure that medically important antimicrobial drugs are used as judiciously as possible, according to Dunham. The idea is to move towards only therapeutic drug use in food producing animals and to move away from sub-therapeutic use for “growth promotion.”
The proposals would limit the use of medically important antimicrobial drugs to those uses that include veterinary oversight or consultation. Use of these drugs would require a prescription; they would no longer be sold over the counter. FDA would use the Veterinary Feed Directive as the framework for regulating medicated feeds. FDA has drafted a proposed rule to update the Veterinary Feed Directive.
Dunham said poultry producers can expect to see a gradual phase-out of use of medically important drugs for production or “growth promotion” purposes. There will be a gradual phase-in of greater involvement of veterinarians. She said that non-medically important drugs will still available over-the-counter and for production use.

US feed industry supports FDA regulation of veterinary medical food

The American Feed Industry Association has encouraged the Food and Drug Administration to continue regulating veterinary medical food as “foods,” in comments submitted to the FDA.
According to AFIA members, veterinary animal foods are formulated from recognized — either as a food additive or generally recognized as safe — animal feed ingredients to help manage a specific disease or condition under a veterinarian’s supervision. “These products have a long history of safe use and do not present any known animal health concerns,” said AFIA Vice President Richard Sellers. “For these reasons, AFIA believes that it is most appropriate for the FDA to continue to regulate veterinary medical foods as 'foods'."
AFIA has proposed a national meeting, co-hosted by the FDA and a university affiliated with the American College of Veterinary Nutrition, to review how to best regulate veterinary medical foods. It has also urged the FDA to issue guidance with regard to its general enforcement policy on unapproved products. Public announcements of the agency’s position, rather than individual enforcements actions, would lead to a more level playing field and ensure that all stakeholders understand the FDA’s thinking and intentions, according to the statement.

Associations urge FDA to make changes to veterinary feed directive

The American Feed Industry Association (AFIA) and National Grain and Feed Association (NGFA) have released a joint statement calling for the Food and Drug Administration (FDA) to make "much-needed improvements" to its current regulatory procedures, in particular the veterinary feed directive (VFD).
The VFD is a regulatory program whereby a licensed veterinarian issues a written statement that authorizes the use of a VFD drug to treat a client's animals, but only in accordance with the directions for use set forth by the FDA. The FDA is considering expanding the program to apply to more than the current two approved drugs as a means to increase veterinary oversight. The AFIA and NGFA, however, said they were "extremely concerned about, and would oppose" such expansion. "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 current VFD regulations," the associations said. Limiting more drugs to approval via the VFD process would only cause more paperwork burdens and regulatory compliance costs for feed manufacturers, the NGFA and AFIA said.
In addition, the AFIA and NGFA listed several proposed improvements to the current VFD process:
• Eliminate the requirement that veterinarians calculate the quantity of feed required to treat targeted animals.
• Eliminate the requirement that VFD orders disseminated by fax or e-mail be followed up with an original copy within five business days.
• Change the records-retention requirement for VFD orders to one year, rather than the current two years.
• Amend existing medicated feed regulations to avoid automatically classifying VFD drugs as Category II, Type A medicated articles.
• Increase educational and training efforts among veterinarians to reduce problems associated with incomplete or inaccurate VFD orders.