During FY2020, FDA’s Center for Veterinary Medicine (CVM)—though hampered by travel and facility visitation limitations due to the COVID-19 pandemic—completed 263 domestic and 13 foreign animal food inspections and 48 domestic and 14 foreign animal drug inspections.

Resulting from those inspections were 11 animal food warning letters and four untitled letters, seven animal drug warning letters, and 14 cross-agency FDA warning letters for cannabidiol (CBD) containing products, among other enforcement actions.

[Related: Are you responsible for quality and compliance at an animal health manufacturer? Learn how Redica Systems can help you stay on top of FDA CVM enforcement actions.]

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At the FDLI Enforcement, Litigation, and Compliance Conference held virtually in December 2020, CVM Office of Surveillance and Compliance Director Timothy Schell reviewed CVM’s activities in FY2020, including its response to issues resulting from the COVID-19 pandemic, regulatory and compliance actions, recalls, implementation of the Food Safety Modernization Act (FSMA), and its closely-watched draft guidance on compounding animal drugs.

CVM Response to COVID-19

During 2020, CVM worked to counteract the effects of the COVID-19 pandemic on animal health supply chains, clinical trials, in-person visits to veterinarians, and attempts to peddle bogus COVID-19 cures.

Schell explained that early in the pandemic CVM proactively contacted animal drug industry players to understand the risk in the supply chains for both the animal drugs and for human drugs that are used in veterinary medicine.

“We set up a mechanism through guidance for industry to forecast and report their shortages so that together we could mitigate any potential supply chain disruptions and keep animal drugs available,” he said.  “With outstanding cooperation with the industry, we have been able to successfully mitigate multiple drug shortages and keep animal drug supplies safe.”

On the drug preapproval side, the Center issued a guidance to account for the COVID-19 disruptions to animal drug clinical trials that was designed to address the potential impact of stay at home orders on clinical studies.

“Our focus was ensuring the safety of animals, their owners, study personnel, and maintaining compliance with the good laboratory practice (GLP) regulations as well as good clinical practices.  And finally, we were interested in maintaining the scientific integrity of the data in these studies.”

…early in the pandemic CVM proactively contacted animal drug industry players to understand the risk in the supply chains

Also addressed was CVM’s coordination with foreign regulatory authorities.  In anticipation of the stay-at-home orders affecting in-person visits to veterinarians, again through guidance, CVM temporarily relaxed some in-person visit requirements of the veterinary client-patient relationship. 

“This allowed vets to expand the use of telemedicine instead of doing an in-person examination when prescribing extra-label drugs and veterinary feed directive drugs,” Schell emphasized.

CVM Eyes Unapproved Products

He also noted that the pandemic offered an opportunity for marketers to capitalize on people’s fears by selling them unproven medical products.  CVM, along with a task force across FDA, closely monitors the marketplace for hazardous drugs and fraudulent products.

The list of fraudulent products for supposedly treating or preventing COVID-19 is a “long one,” and CVM has been busy investigating chloroquine phosphate, ivermectin, and many other unapproved products that are being marketed for animals during the pandemic.

During FY2020, CVM issued eight warning letters to firms marketing over-the-counter unapproved animal drugs related to COVID-19.  The violations include marketing fraudulent products for pets and unapproved chloroquine phosphate for aquarium fish. The unapproved products for aquarium fish with chloroquine phosphate are of unknown quality and pose a public health concern due to the potential diversion to humans who may seek to use the drugs for the purpose of treating or preventing COVID-19.

Animal Food Compliance Actions

Schell explained that animal food and human food are closely related and that the supply chains intersect, and that both have needed attention during the last year.  “We have been working with our FDA colleagues at the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR) within the Commissioner’s office, and of course with our partners across the US government to address food supply issues.”

Early in the pandemic, CVM began working with both the animal feed and pet food industries to mitigate any potential animal food or ingredient shortages.  To help keep food facilities operating, it ensured that workers who support the animal food industry were included in the Department of Homeland Security’s critical infrastructure list for the food and agriculture sector.

On the drug preapproval side, the Center issued a guidance to account for the COVID-19 disruptions to animal drug clinical trials…

For worker safety, it worked with the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) to provide guidance on worker health and animal feed and pet food manufacturing facilities.  Together the agencies developed checklists for continuity of operations and reopening facilities that were closed.

“Through close collaboration with the animal food industry, the animal food supply has remained safe and the industry has been able to keep supply chains up and running,” the CVM Director stressed.

Manufacturing Facility Inspections

CVM continues to conduct mission critical animal drug and animal food inspections.  During FY2020, it completed 263 domestic, 514 State, and 13 foreign animal food inspections and 48 domestic and 14 foreign animal drug inspections.  These numbers represent less than half the number of inspections conducted the previous year.

“For FY2020,” Schell explained, “FDA has developed a rating system to assist us in determining where it is safest to prioritize domestic inspections.  The FDA advisory rating system uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data.”

It is also making the advisory level data available to its state partners who carry out inspections of FDA regulated entities on the agency’s behalf under contract.  It has committed to reviewing that approach quarterly and looking at what activities make the most sense to prioritize and what other activities might be appropriate to perform remotely.

FDA is also pre-announcing all inspections.  This is different from its normal course of business, but it helps to assure the safety of the investigator and the firm’s employees by providing the safest possible environment to accomplish inspectional and regulatory activities.

CVM Enforcement Activity Remains Strong

In FY2020, CVM issued four untitled letters and 11 warning letters to animal food firms, addressing a range of violations of the Food, Drug, and Cosmetic Act, including drug residues, failure to comply with CGMPs, and not implementing proper preventive controls.  CVM also issued one untitled letter under the Bioresearch Monitoring program and seven warning letters to animal drug firms for selling illegal unapproved animal drugs in interstate commerce.

Also issued were 14 warning letters that were sent to companies illegally selling products for animals containing CBD.  These CBD letters addressed products making disease claims without having gone through the approval process and products marketed for food producing animals.

“We continue to be concerned with CBD products that may put animal health at risk, or that may deceive consumers.  We are continuing to monitor the marketplace and act as appropriate to protect public health.”

In addition, two complaints were filed with the US district court, one for GMP violations and the other regarding unapproved animal drugs.

Recalls, Outbreaks, and Risk Assessment

CVM continued to be busy with recalls and outbreak response activities in addition to the COVID responses.  It recently had “significant” recalls for aflatoxin and salmonella in pet food. Pet food safety is a subset of animal food safety and all pet food should be safe.  “We expect all pet food products to be free of pathogenic bacteria, no matter the matrix,” Schell said.

FDA is also pre-announcing all inspections

The preventive controls for animal food regulation requires animal food manufacturers to identify and control hazards based on risk.  These hazards could be biological, chemical, or physical.  Pet food safety also includes having the appropriate nutrients.  Often pet food is an animal’s sole source of nutrition, so imbalances in nutrients even with small nutrients such as vitamins and minerals can have a significant impact.  CVM intends to continue working with the pet food industry to keep that food safe through implementation of preventive controls.

Additionally, CVM continues to respond to natural disasters like hurricanes, flooding, and wildfires.  “We consult with States and firms on reconditioning options for crops and other foods,” he pointed out. “Often products can be safely diverted from human food to animal food, but importantly our primary goal is to keep all foods safe.”

FSMA Update

The 2011 Food Safety Modernization Act—FSMA—was passed to enable FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.  It provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur.  However, building a food safety system based on prevention is a lengthy process.

In his FY2020 update, Schell explained that the agency continues to work on FSMA implementation and is working to finalize CVM Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.  This represents the main preventive controls for animal food. It expects to issue the final guidance in the next calendar year.

“We are also completing separate guidances focused on the recall plan and supply chain provisions,” he explained.  “Those are going to take a little longer to complete.  We will also be finalizing guidance on the human food byproducts.”

…our primary goal is to keep all foods safe

Once the FSMA rulemaking is complete, it plans to focus efforts to transition the new regulation into fully functional inspection programs.  “We have completed a lot of the initial activities that have allowed us and our state partners to begin inspections over the past few years.”

Compliance Program for Animal Food

One of its current activities is to use the experiences it has gained from inspections to refine and finalize a comprehensive animal food compliance program.  The program will provide guidance for field staff to conduct and plan animal food inspections, looking holistically at all the requirements that may apply to a particular facility.  These could include Part 507 CGMPs, preventive controls, medicated feed CGMPS, and their feed directive, bovine spongiform encephalopathy, (BSE), and sanitary transportation components.

“We believe this new program will benefit both the industry and the agency by streamlining the use of resources for both parties when a facility is inspected,” Schell maintained.  “We have also developed our FSMA inspectional training in support of the Food Safety Preventive Controls Alliance (FSPCA).  We continue to refine and improve the training as we deliver.”

“As I mentioned earlier, we are committed to using the knowledge we gained during inspections and communications with stakeholders to make sure our training is up to date and reflective of current industry practices.”

“We are also working on finalizing our approach to ranking our animal food facilities by risk, so that we have the data to drive risk-based inspectional frequencies.  For this effort, we are working on an IT project that will put in place a program that will effectively rank our inventory by risk.”

Animal Drug Compounding

The CVM director also provided an update on CVM’s draft guidance for industry on compounding animal drugs from bulk drug substances.  The draft published in November 2019. Due to COVID-19, it extended the comment period several times, closing on October 15th.  The comments submitted are currently being reviewed and will be used to finalize the guidance.

As outlined in the guidance, unapproved animal drugs, including animal drugs compounded from bulk drug substances, are considered adulterated under the Food, Drug, and Cosmetic Act.  For animal drugs, the only compounding that is legal under the Act is from approved finished dosage form drugs.

However, FDA does recognize that there may not be FDA approved products for all the different illnesses and conditions that can occur in the many different species of animals that veterinarians treat.  A drug compounded from bulk drug substances may be the only treatment option for an animal.

The draft guidance, if finalized, will identify enforcement priorities for compounded animal drugs and describe when the agency does not intend to take action against drugs compounded from bulk drug substances.

Its primary areas of concern for drugs compounded from bulk drug substances are those that present human or animal safety concerns, those that are copies of FDA approved animal drugs, those that are compounded for general office supplies instead of emergency situations, and those that are going to be used in food producing animals.

“With this guidance we trying to strike a balance between the need for drugs compounded from bulk drug substances when an approved alternative is not available, and the risks of compounded animal drugs that have not demonstrated safety and efficacy nor have been reviewed for quality manufacturing or label adequacy through an FDA approval process,” Schell stressed.  “We think this guidance reflects an appropriate balance of these two issues.”

“I would like to reiterate that our draft guidance will still allow veterinarians to prescribe compounded medications for specific patients.  No individual pet or non-food producing animals should be denied a compounded medication by this guidance.”

[Related: Are you responsible for quality and compliance at an animal health manufacturer? Learn how Redica Systems can help you stay on top of FDA CVM enforcement actions.]

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