Have you ever wondered about the brochures, pamphlets, t-shirts, pens, and other promotional materials for animal drugs that are handed out at professional meetings, or by your clinic’s sales representative? These materials are designed to increase sales by providing beneficial information about the drug.
But who oversees these materials? What are the companies allowed to say about their drugs? And how far is too far when promoting a drug?
The FDA Center for Veterinary Medicine (CVM) oversees the promotion and advertising of approved prescription drug products under the Federal Food, Drug, and Cosmetic Act, and related regulations. Animal drug companies must ensure their prescription drug information provided to veterinarians and consumers is truthful, balanced, and non-misleading. CVM’s oversight of promotional materials is accomplished through a comprehensive program including reviewing promotional materials when they are first released to the public, telling animal drug companies if their messaging is inappropriate, and helping them better understand the regulatory boundaries in which they can promote their drug(s).
How does an animal drug company know their regulatory boundaries when promoting their drug?
The simplest answer is to begin with the FDA approved labeling. The labeling is carefully written to include all of the information needed to safely and effectively use the drug. But prescription animal drugs inherently carry certain risks that require a licensed veterinarian to oversee their use. These risks may be identified on the labeling under “Warnings, “Precautions,” “Contraindications,” and other parts of the labeling. Some examples of risk information include: caution against injecting an intravenous medication intramuscularly, as severe tissue sloughing may occur; a warning to use eye protection when administering an otic solution in a dog, as ophthalmic exposure may cause ulcerations; or a warning that animals treated with the drug must not be slaughtered for human consumption within 5 days of the last treatment. Some of the risk information on a drug labeling may be added after the drug is approved when it is used in a larger population of animals and more information becomes available through post-approval monitoring. Animal drug companies are required to disclose risk information in their promotional materials so that veterinarians and consumers receive a message that is balanced with both benefit and risk information.
What about advertisements for prescription animal drugs such as television commercials or pop up advertisements on social media that seem to be directed towards pet owners?
These are known as direct-to-consumer (DTC) advertisements. When the FDA reviews DTC advertisements, they look to ensure the promotional message is truthful and does not mislead consumers into thinking the drug is safer or more effective than has been demonstrated. Consumers cannot legally purchase prescription animal drugs without a valid prescription from their veterinarian; however, DTC advertisements are designed to prompt consumers to request more information from their veterinarians about the drug. These advertisements can provide helpful information to consumers, increase awareness of certain conditions or diseases, and may even influence a consumer to seek veterinary help for their animal; however, the content of the advertisement must be truthful, balanced, clearly communicated and not misleading.
What are some of the common issues CVM finds with promotional materials?
One of the biggest issues CVM finds is promotional materials that downplay the risks associated with the animal drug. This can be either by omission, such as not including certain side effects (e.g. fever, seizures, anaphylaxis, etc.), or by minimizing risk, such as using modifiers (e.g. “in very rare circumstances, mild allergic reactions may occur”) or using barely-legible, tiny font in a print ad. The risk information should be provided with the same prominence and emphasis as the benefit information.
Another common issue found by CVM is the inclusion of misleading information. For example, information taken from a Target Animal Safety Study (a study which determines the drug’s margin of safety), such as the statement that a drug is “Safe at 10X,” can be misleading. While the drug may have been tested at 10x the labeled dose, it may not have been shown to be safe at that dose. Another example is using a meta-analysis to pool multiple studies, each with varying numbers of animals, to create a desired statistically significant outcome that isn’t truly present in the individual studies. For example, if one study has 10 animals, and another has 5000 animals, it is inappropriate and misleading to apply equal statistical weight to both studies.
Overstatement of effectiveness is another common issue. For example, a brochure promoting an animal drug may claim the drug is “100% Effective!” This may be true for an individual field study. However, other field studies and post-approval lack of efficacy reports may show the drug is not ‘100% effective’ after all. Claims made for the animal drug should represent all the data used to support the drug’s approval as well as data collected after the drug is marketed, such as adverse drug event data.
How do animal drug companies know if their promotional materials are appropriate for their drug?
CVM offers “pre-dissemination reviews” of promotional materials for animal drugs that are pending or have already received approval, before the materials are shared with the public. The feedback from these reviews can be very helpful for animal drug companies, preventing them from making unwise investments in costly promotional campaigns. Once CVM has reviewed the materials, the review team either meets with the animal drug company to discuss any issues CVM has found, or sends the company a written summary of concerns that CVM has identified. Pre-dissemination reviews can be very helpful for animal drug companies. Companies can use the comments to make informed decisions about properly promoting their drugs and reducing the risk of CVM action against violative promotional materials.
What kind of actions can the FDA/CVM take against violative promotional materials?
If CVM determines that promotional materials for an animal drug are false, misleading, or violate the law for other reasons, CVM can issue the company an Untitled or a Warning Letter.
Untitled Letters provide a detailed description of the problems found in the promotional materials. They typically cite the regulations the materials violate, causing the drug to be misbranded or adulterated.
Warning Letters are more forceful than Untitled Letters and can result in an enforcement action such as seizure or injunction if the animal drug company does not respond adequately. These actions can be very serious and costly for an animal drug company. When a company receives a Warning Letter, it has 15 working days from the date of receipt of the letter to send us a written response to the violations listed in the letter.
What should you do if you spot an advertisement that is false or misleading?
You can submit promotional materials directly to CVM via: AskCVM@fda.hhs.gov. When submitting “bad ads” to CVM, submit the materials (if possible) along with any additional identifiable information, such as:
- date and time seen,
- location of ad,
- description of media (i.e. journal name/issue date, television channel, etc.),
- intended audience, and
- any other descriptive information.