Inspections, Compliance, Enforcement, and Criminal Investigations
Heska Corporation 05-Jun-07
Department of Health and Human Services
Public Health Service
Rockville MD 20857
JUN 5 2007
Return Receipt Requested
ANADA 200-338 (L-0177)
Marilyn M. Porter, DVM
Regulatory Affairs Associate/Animal Testing
2538 SE 43rd Street
Des Moines, Iowa 50327
Senior Regulatory Compliance Specialist
Schering-Plough Animal Health Corporation
1095 Morris Avenue
Union, NJ 07083-1982
RE: ANADA 200-338 Tri-Heart® Plus (ivermectin/pyrantel); product web site: http://www.triheartplus.com/satisfaction_guaranteed.html;
Dear Dr. Porter and Ms. Thompson-Brown:
We, the Division of Surveillance (DOS), Center for Veterinary Medicine, have reviewed your web site for Tri-Heart® Plus (ivermectin/pyrantel), ANADA 200-338. This promotional piece is misleading because it presents an unsubstantiated claim regarding Tri-Heart Plus, misbranding the drug under sections 502(n) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 352(n) and 321(n)) and FDA implementing regulations, 21 CFR 202.1(e)(6)(i).
Tri-Heart® Plus is an oral antiparasitic medication for use in dogs indicated for prevention of heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilarfa immitis) for a month (30 days) after infection and for the treatment and control of ascarids (Toxocara canis, Toxocara leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).
On March 6, 2007, CVM sent an untitled letter to you objecting to promotional labeling piece spah-thp-27R2. The promotional labeling piece in question was a mailer entitled "The most Comprehensive Guarantee in Heartworm Prevention" which included a guarantee relating to whipworms. Schering-Plough Animal Health responded by letter dated April 6, 2007, agreeing that the claims presented in the piece were overstated, and agreeing to immediately cease dissemination of the piece and any others with the same language. The April 6, 2007, response letter stated that future promotions will read, "Tri-Heart® Plus is not approved or effective for removal or control of whipworms, but if you prescribe Tri-Heart® Plus to a whipworm negative dog and the animal is diagnosed with whipworms within the Tri-Heart® Plus use period, our guarantee will cover the cost of a remedial treatment."
Unsubstantiated Claim of Effectiveness
As of the date of this letter, your web site page entitled "About Tri-Heart® Plus-100% Satisfaction Guaranteed" contains the following statement: "Our Guarantee Covers . . .Tri-Heart® Plus is not registered for removal and control of whipworms, but if you prescribe Tri-Heart® Plus to a whipworm negative dog and the animal is diagnosed with whipworms within the Tri-Heart® Plus use period, our guarantee will cover the cost of a remedial treatment." Despite your agreement to immediately cease dissemination of the mailer piece spah-thp-27R piece and any others with the same language, your web site continues to include the exact statement we objected to in our letter dated March 6, 2007.
Additionally, the web page entitled "Heartworm and Other Parasites" states "Many heartworm preventive medicines for pets do eliminate other parasites such as hookworms, whipworms and roundworms . . ." The page then offers a description of hookworm, roundworm, and whipworm infections in dogs. These statements suggest Tri-Heart® Plus is among the referenced heartworm preventative products that are effective for the prevention, removal and/or control of whipworms. These indications, however, are not permitted under the product's approved labeling and CVM is not aware of substantial evidence to support a claim of effectiveness against whipworms for your product. If you have supporting data, please submit it to FDA for review.
In addition, the suggested revised statement in your April 6, 2007, letter continues to imply effectiveness of Tri-Heart® Plus for the prevention of whipworms. Despite the disclaimer that the product is not approved or effective for removal and control of whipworms, the guarantee still suggests that Tri-Heart® Plus is effective for the prevention of whipworms. The statement thus continues to be misleading by overstating the product's demonstrated effectiveness.
Conclusion and Requested Action
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Tri-Heart® Plus, as well as for your other products, comply with the requirements of the Act and its implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action without further notice such as seizure and/or injunction.
You should notify this office in writing of the steps you have taken-to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
In addition, we request that you immediately cease the dissemination of violative promotional materials for Tri-Heart® Plus such as those described above. Specifically, you should correct the promotional materials on your web site concerning Tri-Heart® Plus and any other materials that may contain similar information. Future promotional materials should adequately address the claims of heartworm and other intestinal parasite prevention, described in the currently approved labeling, without overstating the effectiveness. Because the violations described above are serious, we request that your submission include a comprehensive plan of action to disseminate a truthful, non-misleading, and complete corrective message about the issues discussed in this letter to the audience(s) that received the violative promotional materials.
Please send your written reply to the Food and Drug Administration, Attention: Martine Hartogensis, 7519 Standish Place, Rockville, MD 20855. If you have questions: Martine regarding any issue in this letter, you may contact us at (240) 276-9064.
Lynn O. Post, DVM, PhD, DABVT
Director, Division of Surveillance
Center for Veterinary Medicine