FDA antiseptic TFM "broad enough" to cover antibacterial lotions -- industry petition.

FDA ANTISEPTIC TFM "BROAD ENOUGH" TO INCLUDE ANTIMICROBIAL LOTIONS, CTFA and other industry trade groups maintain in a June 12 citizen petition to the agency. Submitted in conjunction with the Soap and Detergent Association and the Nonprescription Drug Manufacturers Association, the Cosmetic, Toiletry and Fragrance Association petition argues the scope of the tentative final monograph for OTC health care antiseptic drug products covers lotions making antibacterial claims. The section of the TFM addressing the antiseptic handwash category "is broad enough to encompass antimicrobial hand lotions, particularly in light of the fact that the TFM provides specific label directions for application of antiseptic handwashes without water or rinsing," the industry groups assert.

"The scientific merit and regulatory status of topical antimicrobial products, including currently marketed hand lotions, are in fact intended to be considered in the context of the ongoing review of topical antimicrobial OTC drug products, and their conditions of use are consistent with the terms of the tentative final monograph," the petition declares.

In general, "a monograph should not be considered to be limited to a specific dosage form," the petition argues. "In fact, it is important, as different formulation technology evolves to deliver the active ingredients, that a monograph be flexible to incorporate those dosage forms." The TFM for antiseptic drug products was published June 17, 1994 as part of an ongoing, broad rulemaking process for products with antimicrobial, antibacterial and antiseptic indications.

The citizen petition was filed in response to a May 8 warning letter issued by FDA to Bristol-Myers Squibb regarding the company's Keri Anti-Bacterial Hand Lotion ("The Rose Sheet" June 15, p. 5). The letter states that "prophylactic claims" made by BMS for the .3% triclosan lotion, including the claim "to help reduce bacteria that potentially can cause disease," cause the product to be an unapproved new drug. The preventative indications "do not qualify for evaluation under the ongoing OTC drug review being conducted by FDA," the agency maintains.

The industry petition requests that FDA "refrain from taking enforcement action" against Keri Anti-Bacterial Hand Lotion or "any antimicrobial product containing any active ingredient" listed in the TFM "on the basis that its dosage form (e.g., it is a `lotion') is not covered by the TFM."

The action against BMS should be withdrawn or suspended, the petition continues, "pending the determination of the status of such product as part of the ongoing topical antimicrobial drug product rulemaking." Furthermore, the trade groups assert, "no similar or additional actions [should] be taken until the completion of this monograph process."

Submission of a citizen petition in support of one company is unusual for an industry association. CTFA, NDMA and SDA note in the document they "do not normally take a position with respect to an enforcement action affecting a specific company" and clarify that they are not taking a position regarding issues specific to the Keri lotion. However, the petition adds, the warning letter "appears to have broader implications that are of vital interest to the industry as a whole."

The trade groups suggest FDA retract the enforcement action "to preserve the integrity" of the monograph process. "We believe this new enforcement action undermines a fundamental premise of OTC review -- consideration of the entire range of potential active ingredients and dosage forms as part of a comprehensive review of a drug product category."

"Because the topical antimicrobial monograph is not yet final, FDA should defer any regulatory action against labeling that allegedly varies from that provided in the TFM," the petition asserts. The document points out that "in accordance with FDA's enforcement policy," the agency should not take enforcement action "unless there is a reasonable basis to conclude that the deficiency constitutes a potential hazard to health, a factor that is clearly not present in this case."