Healthy Skepticism Library item: 10215

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Warning Letter to KV Pharmaceutical re Clindesse (clindamycin phosphate) Vaginal Cream Marketing
: US FDA 2007 May 17
http://www.fda.gov/CDER/warn/2007/Clindesse_ltr.pdf

Abstract:

“…The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed an e-
Pharm/alert e-mail for Clindesse (clindamycin phosphate) Vaginal Cream, 2% announcing “Clindesse at
UnitedHealthcare® On formulary” submitted by KV Pharmaceutical Company (KV) under cover of
Form FDA 2253. The e-Pharm/alert e-mail is false or misleading because it overstates and misrepresents the efficacy of Clindesse, presents unsubstantiated superiority and patient compliance
claims, and minimizes the risks and limitations to the indication associated with Clindesse. Thus, the e-Pharm/alert e-mail misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 352(a) & (n). Cf. 21 CFR 202.1(e)(5)(ii); (e)(6)(i), (ii), (vii), (x); (e)(7)(i), (iv), (viii). These violations are concerning from a public health perspective because they suggest that Clindesse is more effective than has been demonstrated…”

Notes:

Link to promotional material:
http://www.fda.gov/CDER/warn/2007/clindesse_promo.pdf (4.67 MB)