FDA Denies Citizen Petition to Amend OTC Monograph for Healthcare Antiseptic Drug Products

By Susan J. Matthees –

By letter of March 26, 2010, FDA denied a 2003 Citizen Petition from CTFA (now PCPC) and The Soap and Detergent Association which had requested FDA to include antiviral indications, labeling, and test methods in the Tentative Final Monograph ("TFM") for OTC Healthcare Antiseptic Drug Products (59 Fed. Reg. 31,402).  The industry had long chafed under FDA’s restriction of OTC topical antimicrobials only to antibacterial use. 

In denying the Citizen Petition, more than 7 years later, FDA concluded that: (1) the data submitted did not “clearly demonstrate” antiviral effectiveness; (2) the proposal to use surrogate viruses to test antiviral effectiveness was unacceptable because of the variability of viruses in their susceptibility to antiseptics; (3) the proposed effectiveness criterion of a 2-log10 reduction was unsupported; (4) the proposed ASTM test methods were inadequate; (5) the proposed antiviral labeling is unsupported by evidence of effectiveness, and may be misleading; and (6) some of the active ingredients are not eligible for inclusion in the OTC healthcare antiseptics review because they did not include antiviral claims in their pre-1972 labeling.

Despite the agency’s across-the-board rejection of the Citizen Petition, the letter asserts:  “we believe that the availability of products with demonstrated antiviral activity would be of benefit to healthcare professionals, consumers, and foodhandlers, and we encourage you to submit additional data on this issue.”  At present, however, the agency does not intend to add antiviral claims to the OTC healthcare antiseptic TFM. 

But in an apparently contradictory statement, FDA was “able to document the pre-1972 marketing of healthcare personnel hand-washes containing benzalkonium chloride, providone-iodine, and triclosan for an antiviral indication.”  Therefore, these products may be eligible for consideration of antiviral claims in the OTC healthcare antiseptic review.  Moreover, these products could be marketed now with antiviral claims while the review is pending, pursuant to FDA’s enforcement policies.  See Compliance Policy Guide (CPG) 7132b.15, CPG Manual 450.200; see also 21 C.F.R. § 330.13.  The agency may have created at least a short-lived marketing opportunity for some products.