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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Has Significant Role in Regulating Advertising, Labeling of New Animal Drugs

by Carmela Stamper, DVM, Communications Staff, with contributions from Thomas Moskal, DVM, Division of Surveillance, Office of Surveillance and Compliance
FDA Veterinarian Newsletter January / February 2008 Volume XXIII, No I

The Food and Drug Administration’s Center for Veterinary Medicine is responsible for regulating the labeling and advertisements for prescription veterinary drugs and labeling for over-the-counter (OTC) products.  Although advertising of OTC products is regulated by the Federal Trade Commission (FTC), CVM still plays a role. When CVM becomes aware of an advertisement for an OTC product that is false or misleading, it can forward this information to the FTC for review and possible action.

Food and drug regulations require sponsors of new animal drugs to submit labeling for prescription and OTC new animal drugs to CVM at the time of initial dissemination of the labeling and require sponsors to provide advertisements for prescription new animal drugs to CVM at the time of initial publication or broadcast. CVM reviews these labeling and advertising materials to assess whether the materials contain only truthful, non-misleading information and provide risk and other information required to be included in these materials.

When CVM determines that promotional materials contain false or misleading information, the Center has several tools available to ensure compliance with the law, including achieving voluntary compliance through Untitled Letters and Warn-ing Letters.

In Untitled Letters, CVM cites the violations found in the various labeling and advertisement pieces and asks sponsors to respond in writing to the cited violations, generally within 30 days. Similarly, in Warning Letters, CVM cites the violations found in the labeling and advertisement pieces. However, additional language is included indicating that CVM may take further regulatory or enforcement action against the sponsor. Also, sponsors are asked to reply in writing within 15 days of receipt of the Warning Letter, rather than the 30 days associated with Untitled Letters.

In October 2007, CVM began posting on its Web site violative promotional labeling and advertisement pieces along with the corresponding Untitled and Warning Letters to allow sponsors to review the original material that CVM objected to and learn from these examples.

Previously issued Untitled Letters can be found at http://www.fda.gov/CVM/2007letters.htm and Warning Letters at http://www.fda.gov/foi/warning.htm.

In 2007, CVM issued four Untitled Letters and five Warning Letters to sponsors in response to various labeling and advertisement violations. The letters principally cited either unsubstantiated claims or failure to include the required risk information.

Untitled Letters

In March 2007, CVM sent an Untitled Letter to a firm for overstating the effectiveness of its heartworm preventive product. The promotional piece suggested that the product was effective for the prevention, removal, and/or control of whip-worms in dogs. However, the company had not provided evidence to support this claim of effectiveness.

In May 2007, CVM sent an Untitled Letter to a firm citing unsubstantiated safety claims and minimization of risks in several promotional labeling pieces for a canine non-steroidal anti-inflammatory drug (NSAID). The promotional pieces con-tained language implying that the product was safer, with respect to ulcers, than other currently approved canine NSAIDs. However, the firm had not provided evidence to support this claim. The promotional pieces also minimized the risks asso-ciated with product use. In particular, statements that communicated favorable information about the product were pre-sented as large, bold headers, while the risk information was presented in a smaller, more difficult to read font. Because the risk was minimized, the product was considered misbranded.

In August 2007, CVM sent an Untitled Letter to a firm citing minimization of risk information and promotion of the drug for a new unapproved use. The promotional piece at issue contained statements that promoted an unapproved, more frequent product dosing regimen. Because the product was not approved for the stated dosing regimen, the product was rendered unsafe and adulterated.  The promotional piece also omitted important risk information, thus causing the product to be misbranded.

And, in October 2007, CVM issued an Untitled Letter to a firm citing several violations: promoting a new unapproved use, omitting risk information, overstating the product’s effectiveness, and using labeling that did not conform to the ap-proved product labeling. Three promotional pieces for an equine dewormer promoted a new unapproved use: once every-other-month, year-round product use for protection of horses from tapeworms and other parasite infections. Because the product was not approved for every-other-month, year-round use in horses, the product was considered unsafe and adul-terated.  The product packaging associated with the new unapproved use also rendered the product unsafe and adulter-ated because it did not conform to the approved product labeling. All three pieces also omitted risk information regarding oral swelling and irritation found in the “Post-Approval Experience” section of the approved labeling. That omission caused the product to be misbranded. Furthermore, one piece contained statements implying 100 percent effectiveness against certain worm species and stating that no rotational use in conjunction with other dewormers was needed. Because the firm did not provide evidence to support the claims, the product was considered misbranded.

In each of the four Untitled Letters, CVM asked the sponsors to immediately cease dissemination of the violative materials and to officially respond within 30 days regarding their intent to comply with CVM’s requests.

Warning Letters

In June 2007, CVM sent a Warning Letter to a firm citing the minimization of risk associated with the use of the drug and failure to reveal material facts about the product in a television ad. In this case, the product also contained a “Boxed Warning,” sometimes referred to as a “Black Box” warning. The television advertisement inadequately communicated the risks associated with the use of the product. Specifically, the advertisement failed to communicate the information in the Boxed Warning, thereby minimizing the risks associated with the product and misleadingly suggesting that the product is safer than had been demonstrated.

In addition, the letter cited the firm for failing to reveal relevant risk information in a non-broadcast promotional labeling piece. The Warning Letter cited the absence of adequate information regarding risks, which could result in the unsafe use of the product.

CVM sent three Warning Letters in June 2007 to firms for overstating their products’ effectiveness claims. In one case, an advertisement for a canine heartworm preventive implied that use of the product would prevent transmission of zoonotic disease to humans. The company, however, had not provided any effectiveness data or clinical experience to support this claim. In the second case, an advertisement for a different canine heartworm preventive product suggested that the product was effective for the prevention, removal, and/or control of whipworms, but the company had not provided any evidence to support this claim of effectiveness. In the third case, various advertisements and labeling failed to reveal that the effectiveness data for the drug was the result of using the drug in conjunction with a behavior modification plan, as indicated on the approved label.  These pieces were misleading because they suggested that the drug was more effective than had been demonstrated.

In July 2007, CVM sent a Warning Letter to a firm for both overstating the effectiveness of a drug and promoting a new unapproved intended use. The promotional piece at issue contained unsubstantiated effectiveness claims, suggesting that the Veterinary Feed Directive status of the drug related to its long-term effectiveness. Furthermore, the drug was pro-moted as being able to significantly increase average daily weight gain in pigs. Because the product was not approved for use in increasing average daily weight gain in pigs, the product was considered unsafe and adulterated.

In each of the five Warning Letters, CVM asked the sponsors to officially respond in writing within 15 days to the cited issues, stop dissemination of the violative pieces, and propose corrective actions. In some cases, CVM requested that the company include a comprehensive plan of action to disseminate a truthful, non-misleading, and complete corrective mes-sage about the issues discussed in the letter.

Conclusion

Because of the potential impact on the safe use of animal drugs, CVM takes false or misleading labeling and advertis-ing seriously. Regulatory tools including Untitled and Warning Letters help CVM obtain voluntary compliance. Posting the letters on the Web provides a learning example to all companies involved in promoting animal drugs.