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U.S. Department of Health and Human Services

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Enforcement Actions

Elanco Animal Health 26-Jun-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Food and Drug Administration
Rockville MD 20857


 

JUN 26 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

NADA 141-272 (L0017)

Margaret Gillis
Regulatory Associate
Elanco Animal Health
2001 W. Main Street, DC GL21
Greenfield, IN 46140

RE: NADA 141-272 Reconcile™ (fluoxetine hydrochloride);
promotional pieces and product website (reconcile.com).

Dear Ms. Gillis:

We, the Division of Surveillance, Center for Veterinary Medicine, have reviewed the article "Separation Anxiety: A Brief Overview" for Reconcile™, NADA 141-272, submitted by Elanco Animal Health under cover of form FDA 2301 dated May 04, 2007. We also reviewed the reconcile.com website. In addition, the Division of Surveillance has reviewed a promotional piece RE00053 (consumer brochure) and a print advertisement REC005305 (in the May issue of Veterinary Forum Magazine). These pieces and the product website are misleading due to incomplete information concerning the effectiveness of Reconcile™. These pieces and the product website suggest that the product is more effective than has been demonstrated. Therefore, the drug is misbranded within the meaning of 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)].

Background

Reconcile™ (fluoxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.

The approved package insert contains the following statements:

"At the end of the 8-week study, 73% of dogs treated with Reconcile™ chewable tablets showed significant improvement (p=0.010), as compared to behavior modification alone (51%). During the course of therapy, 42% of dogs showed improvement within the first week, which was significantly greater (p=0.005) than with behavior modification alone (18%)."

and

"At the end of the study, 73% of dogs treated with RECONCILE chewable tablets showed significant improvement (p= 0.010) as compared to 51% of dogs treated with behavior modification alone."

Failure to reveal material facts

The article "Separation Anxiety: A Brief Overview" contains the following statement:

"In a clinical field trial, 73 percent of dogs receiving Reconcile™ showed significant improvement within eight weeks, compared to placebo-treated animals, and 42 percent of dogs receiving Reconcile™ showed significant improvement within one week compared to placebo-treated animals."

The Reconcile™ website and the consumer brochure for Reconcile™ (RE00053) contain the following statements:

• 73% of dogs receiving Reconcile™ showed significant improvement within eight weeks compared to placebo-treated animals.

• 42% of dogs receiving Reconcile™ showed significant improvement within one week compared to placebo-treated animals.

The print advertisement in the May issue of Veterinary Forum Magazine (REC005305) contains the following statements:

• 73% of dogs showed significant improvement within eight weeks compared to placebo-treated animals.

• 42% of dogs showed significant improvement within one week compared to placebo-treated animals.

The above-quoted statements fail to disclose that the dogs in the comparison group were treated with behavior modification and did not just receive a placebo. The article "Separation Anxiety: A Brief Overview" additionally fails to disclose that the dogs receiving Reconcile™ in the study had also been treated with behavior modification. Moreover, the materials do not state that for the dogs in the comparison group, which received a placebo and were treated with behavior modification, 51% showed significant improvement by the end of the eight week study and 18% showed significant improvement within the first week. Failing to reveal this information makes the above quoted statements misleading because they suggest that Reconcile™ is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The article also fails to disclose that claimed results may be due to a concomitant therapy, behavior modification.

In a teleconference on April 23, 2007, CVM spoke with representatives from Elanco Animal Health to discuss Dear Doctor letters (RE00062-041707 and RE00000-41707) that were to be sent to veterinarians and veterinary clinics. These letters contained similar effectiveness claims as in the labeling and advertisement quoted above. CVM requested the Dear Doctor letters be revised to more accurately reflect the approved label. At that time, Elanco agreed to revise the Dear Doctor letters. On May 1, 2007, Elanco sent revised Dear Doctor letters (RE00062-042407 and RE00064-05xx07) electronically to CVM. These Dear Doctor letters contained the following revised statements:

"• Within eight weeks, 73% of dogs treated with Reconcile™ chewable tablets showed significant improvement as compared to behavior modification alone (51%)."

"• 42% of dogs showed improvement within the first week, which was significantly greater than with behavior modification alone (18%)."

As previously conveyed to Elanco, CVM finds these revised statements, which disclose the fact that within 8 weeks, 51 % of dogs showed significant improvement with behavior modification alone, acceptable.

Conclusion and Requested Actions

As discussed above, the claims made in these pieces and the product website are misleading and cause the drugs to be misbranded within the meaning of sections 502(n) and 201(n) of the Act [21 U.S.C. 352(n) and 321(n)] and FDA implementing regulations at 21 CFR 202.1(e)(6)(i) and (vi).

The Division of Surveillance requests that Elanco Animal Health immediately cease the dissemination of the violative pieces for Reconcile™ such as those described above. Future promotional labeling and advertisements should not overstate the effectiveness of Reconcile™. Because the violations described above are serious, we request that Elanco submit a comprehensive plan of action to disseminate a truthful, non-misleading and complete corrective message about the issue discussed in this letter to the audience(s) that received the violative materials.

Elanco should notify this office in writing within fifteen (15) working days of receiving this letter of the steps it has taken to bring the Reconcile™ website and other material into compliance with the law. The 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.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to see that the labeling and advertisements for Reconcile™ (fluoxetine hydrochloride), as well as other Elanco Animal Health products, comply with the requirements of the Act and FDA implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action without further notice such as seizure and/or injunction.

If you have any questions, please contact me at the address above, or call me at (240) 276-9061. All future written correspondence regarding this matter should reference our file number NADA 141-272 (L0017).

Sincerely yours,

/S/

Lynn O. Post, D.V.M., PhD, DABVT
Director, Division of Surveillance
Center for Veterinary Medicine