Advocacy in action
FDA seeks input on unapproved drug issue

The US Food and Drug Administration (FDA) recently published a Federal Register Notice (Docket No. FDA-2010-N-0528 – Unapproved Animal Drugs) requesting public comment on the handling of unapproved animal drugs. The AASV offered comment and I thought I would take a minute to update you on this issue.

The FDA requested input on implementing a mechanism by which the agency could establish a category of approval status to legitimize some of the many unapproved products currently marketed to veterinarians and producers. In actuality, the number of unapproved products (those that have never been subjected to the FDA approval process) on the market far surpasses the number of approved products. The FDA admits that the issue should have been addressed earlier but has been of relatively low priority within the agency.

The FDA has addressed a similar issue in the human drug market through the use of a monograph process. This process entails an evaluation of the product by a group of experts to identify potential safety concerns. There is limited if any scientific analysis of the product for safety or efficacy, with the participants relying on an evaluation of the ingredients used in the manufacture of the product and its history for animal, human, and food safety.

Many of these products have been used for years with no apparent risk to animal or human health. However, due to the limited market potential, manufacturers may not have felt it was economically justifiable to undertake the costs associated with submitting the products to FDA for approval through the New Animal Drug Application (NADA) process. All FDA-approved products are assigned an official NADA number. Unfortunately, there is no current requirement that a manufacturer include the NADA number on the product label. Therefore, it is not possible for a producer or veterinarian to look at a product and determine whether or not it is an officially approved drug. Animal Drugs @ FDA is the agency’s official database listing all approved animal drugs. The database can be accessed online (

The recent Federal Register Notice sought input from the public on establishing a method by which certain marketed, unapproved animal drugs could be determined to be safe for labeled uses and thus afforded a legally approved status without having to undergo the complete evaluation necessary under the NADA process. We consulted with the AASV Pharmaceutical Issues Committee in an effort to develop the following comments in response to the agency’s request:

“Swine veterinarians and producers have a limited number of drugs approved for use to treat conditions commonly encountered in swine production. Some currently unapproved drugs are effective and have been used safely for many years resulting in improved animal health, wellbeing and food safety. In some cases, such as the topical treatment of wounds, there are no products specifically approved for use in swine. Therefore, the loss of currently marketed unapproved products would result in additional treatment challenges.

The FDA has developed a monograph process to address this situation in human medicine. This process allows for the evaluation of unapproved products and, if determined to be safe, the recognition of a legally-approved status. The agency is considering a similar means to afford a legal status for the use of unapproved animal drugs in veterinary medicine as well.

The AASV supports FDA’s efforts to address this issue in a manner that would allow for the legal marketing and use of currently unapproved products that are deemed to be safe for use and pose no significant food safety or public health risk. In addition, these products should be manufactured in facilities that meet cGMP or similar standards and be subject to established quality control specifications that ensure product consistency and safety. The method used to establish the approval status of currently unapproved drugs must not be overly burdensome or costly as manufacturers of the products under consideration cannot economically justify extensive product review. It is also critical that this effort not supersede the current NADA process for the scientific and thorough evaluation of animal drugs. Likewise, the evaluation of unapproved products should not divert resources from or slow the NADA process.

The FDA needs to define specifically what any new ‘category’ of approval would mean relative to the subsequent use of those products. Would products approved through this process be afforded status equivalent to that of NADA-approved products with regards to label compliance, extra-label use, withdrawal periods, etc. or would there be additional restrictions governing the use of this category of approved products?

Also, the FDA should consider requiring the inclusion of a product’s approval status on the product label. Currently, it is impossible for a veterinarian or producer to look at a product label and determine whether or not that product has received FDA approval. In addition, the FDA should enforce regulations governing the marketing of products determined to be unsafe, illegally compounded or manufactured in facilities not in compliance with established standards.

The presence of marketed but unapproved products leads to confusion for veterinarians and producers, results in the use of illegal animal health products and raises concerns for consumers and retailers. The AASV supports the establishment of a method by which safe effective products could be evaluated and approved for use to address those conditions for which no approved or effective product exists in an effort to improve animal health and wellbeing while preserving human and animal safety, food safety and public health.

You can view the AASV comments in their entirety at by entering document number FDA-2010-N-0528. We will attempt to keep you informed as this effort progresses and we welcome your thoughts and input.

-- Harry Snelson, DVM
AASV Director of Communications