Issues and Advocacy

FDA Approval

About the FDA’s Safety Assessment for Food Animals

Frequently Asked Questions on the FDA Approval Process

The standards and processes for reviewing pharmaceuticals intended for animals are the same in most respects as those used for reviewing drugs intended for humans. In fact, approval for both human and animal drugs is overseen by the FDA.

The drug approval process through the FDA includes a complete evaluation of the drug’s metabolism, its interaction with other drugs, and potential differences of effectiveness or safety.  The drug must be shown to be effective for the labeled indications. The FDA assesses the most common side effects and examines the range of doses that patients can take safely without a high rate of side effects. They also look at short-term, relatively common side effects.

The process for both human and animal drug approval includes a safety assessment, requiring animal pharmaceutical companies to submit data showing use of the antibiotic is safe for the human or animal in which it is to be used. If there are any significant side effects that could result from administering the antibiotic, labeling is required.

However, the safety assessment for food animals is more stringent than that for human antibiotics in three ways:

1) If there are risks to humans, FDA will not approve the antibiotic for animals.
While the FDA conducts a risk-benefit assessment for human antibiotics, there is no consideration of benefits in the review of antibiotics used in food animals. This means that the risk to human health for products under review must be extremely low since the FDA does not consider any benefits to offset the risks.

2) FDA requires a food safety assessment to ensure that meat is safe.
The safety assessment for food animal antibiotics requires sponsors to submit toxicology and food residue studies to ensure that meat from animals treated with a certain antibiotic will be safe for human consumption. Data from these studies are used to establish withdrawal periods, or periods prior to harvest during which antibiotics cannot be used in order to ensure that the final food product is free of residues above tolerance levels.

3) FDA studies the pharmaceutical thoroughly to guarantee it does not increase the risk of antibiotic resistant bacteria in food.
In 2003 the FDA implemented an additional safety measure that “outlines a comprehensive, evidence-based approach to preventing antimicrobial resistance that may result from the use of antimicrobial drugs in animals.” ¹ This process was a priority action item in the U.S. Public Health Action Plan.

Both the animal and human approval processes require an efficacy assessment. Animal health companies must conduct statistically-designed and geographically diverse studies, showing the antibiotic will provide clinical improvements or cure.

Finally, both processes require a quality or manufacturing assessment. The FDA inspects pharmaceutical facilities, assures product stability and adherence to Good Manufacturing Practices.

Frequently Asked Questions on the FDA Approval Process

  • When the FDA approves a new antimicrobial animal drug, does it take into account the drug’s importance to human health?

The FDA has always examined the impact of animal drugs, including antibiotics, on human health whether or not those drugs are also important for treating diseases in humans. With antimicrobials, the FDA requires the sponsor of a new antimicrobial product for food animals to demonstrate that the final food product is free of antimicrobial residues above certain levels, and to evaluate the potential for an animal antimicrobial that may also be medically important to humans to develop a resistance that could be transferred to humans.

The FDA requires the company to conduct a qualitative risk assessment for a new antimicrobial in order to rank the drug as critically important, highly important, or important to human health. This level of importance effects whether or not the FDA approves the drug, and if so, under what conditions of use.

  • What happens if the FDA concludes that the drug is important to human health?

The FDA could decide not to approve the drug for use in animals, depending on its ranking (mentioned above). If the FDA does decide to approve the drug, however, they can impose an array of restrictions designed to protect public health, such as limiting the antibiotic’s conditions of use. For example, the FDA can state that the antibiotic should only be used for short term therapy or available only on the order of a licensed veterinarian.

  • Are there situations where FDA’s Guidance 152 has resulted in more restrictive labeling of a product?

As a result of Guidance 152, it would be highly unlikely for any antibiotic ranked as critically important for human medicine to be approved by the FDA for use in the feed of livestock or poultry. However, some antibiotics have been approved for limited use as individual animal injections under the supervision of a veterinarian for specific and serious animal diseases.

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