Industry groups say they have learned little from FDA and need to know more about the agency’s expectations for testing protocols for clinical studies and other data supporting the safety and efficacy of antibacterial ingredients other than triclosan.

With December 2014 deadline for submitting information to FDA passed, the Personal Care Products Council and American Cleaning Institute are asking for an extension and for a meeting with agency officials to discuss studies on benzethonium, benzalkonium chloride and other ingredients that, in addition to triclosan, are under consideration for inclusion in FDA’s tentative final monograph for consumer antiseptic washes.

In a Dec. 16 letter to FDA’s Center for Drug Evaluation and Research, PCPC and ACI acknowledge the agency’s commitment to publish a final monograph for consumer antiseptic washes containing triclosan by Sept. 15, 2016.

The agency agreed to the timeline in a consent decree settling a suit brought in 2010 by the National Resources Defense Council environmental advocacy group Also see "Consent Decree Orders FDA Action On Triclosan OTC Monographs" - Pink Sheet, 5 December, 2013..

However, the groups note other active ingredients covered in a December 2013 proposed rule to amend the tentative final OTC monograph for topical antimicrobial drug products are not subject to the same timeline. The proposed rule would require “a new and significant set of testing requirements” for establishing ingredients in consumer soaps as generally recognized as safe and effective.

Healthcare Antiseptic TFM To OMB

FDA on Jan. 17 submitted for Office of Management and Budget review a tentative final Healthcare Antiseptic Products monograph, for antiseptic washes and rubs used by health care personnel and as preoperative skin preparations.

The agency included in the TFM recommendations made at a Nonprescription Drugs Advisory Committee meeting in September 2014. The TFM will be available for public comment after OMB determines whether the document accurately reflects burdens the requirements will impose on affected businesses.

In a November 2014 progress report on its compliance with a 2013 consent decree requiring publication of antiseptic hand wash final monographs, FDA said it is re-evaluating antiseptic ingredients due to scientific developments showing their potential to cause hormonal effects and their role in the development of antimicrobial resistance.

According to the report, “developing the TFM for Healthcare Antiseptic Products has required [FDA’s Division of Nonprescription Drug Products] to review and assess the complex, developing body of scientific research and other information on the safety and effectiveness of 29 active ingredients, including triclosan, triclocarban, alcohol, and iodine. This has required the resolution of numerous complex medical, scientific, policy, and legal issues in such areas as ingredient classification and safety and effectiveness testing, among others. DNDP has consulted with other safety experts inside and outside of FDA.”

“The fact that FDA has committed to a specific timeline under a consent decree for taking final action regarding triclosan does not provide a basis for FDA to deny industry’s requests to engage with FDA to discuss testing protocols for the other active ingredients, nor does it provide a basis for FDA to take any final action regarding these ingredients on the same timeline to which it has committed for triclosan,” the industry associations say.

“To do so would be arbitrary, capricious and not in the best interest of the agency, industry or the public,” they add.

PCPC and ACI note industry is undertaking studies on benzethonium and benzalkonium chloride specifically, among others under consideration for ingredients included in the tentative monograph. Such research will be expensive and time-consuming, the groups point out.

“While industry is willing to incur this expense, we believe it is critical that we meet with FDA to discuss study design so that the evidence we gather will be useful to FDA,” they say.

The trade organizations also renew their request made in their June 2014 comments on the proposed rule for additional time to conduct studies, a request first. “We believe that the time to conduct studies set forth by FDA is unreasonably short,” they say.

New Studies Will Take ‘Several Years’

NRDC’s lawsuit filed in 2010 sought to force FDA to finalize its position on the use of triclosan in antibacterial soaps and whether the ingredient qualifies as GRASE, which the agency determined was not supported by sufficient data in its tentative final monograph issued in 1978.

In the absence of a final rule, triclosan has remained on the U.S. market, present in about 93% of antibacterial products, despite emerging animal research suggesting hormonal risks and mounting questions regarding the ingredient’s benefit in antibacterial soaps compared with plain soap and water.

“It’s outrageous that FDA has waited 35 years to protect the public from this harmful chemical,” Mae Wu, an attorney in NRDC’s health program, said following the consent decree in 2013.

“Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water. In fact, not only do soaps containing triclosan fail to provide benefits consumers might expect, they carry potential health risks,” Wu added, holding that FDA’s final monograph should prohibit the ingredient’s use.

Following the settlement with NRDC, FDA published a proposed rule to establish conditions under which OTC consumer antiseptic washes – soaps and other personal cleansing products used with water – are GRASE, citing a need for additional safety data in light of “recent scientific developments and changes in the use patterns of these products,” as well as evidence of clinical benefit Also see "FDA Says Industry Has Work Left To Do To Make Antiviral Claims For Topicals" - Pink Sheet, 19 April, 2010..

In the area of safety, FDA called for preclinical and human pharmacokinetic studies, developmental and reproductive toxicity studies and carcinogenicity studies, as well as data to characterize potential hormonal effects and ingredients’ contribution to bacterial resistance.

To demonstrate efficacy, FDA asked for clinical outcome studies demonstrating a reduction in infections as a result of antibacterial soap use.

PCPC and ACI maintain the proposed requirements are “unprecedented” and surpass those expected of firms filing new drug applications for antiseptics, based on prior approvals.

Nevertheless, they helped fund a study submitted to FDA in June 2014 demonstrating the superior effectiveness of antibacterial formulas, compared with non-antibacterial alternatives, at reducing risk of an infectious disease often spread during food preparation. Antibacterial solutions included one containing 0.46% triclosan, as well as formulas powered by chlorhexidine gluconate and ethyl alcohol ([A#05140428009]).

In their letter, the groups note they sought engagement with FDA before and since the agency issued its proposed rule, but their requests have not been granted or answered with written responses. They maintain greater collaboration is needed.

“It will take several years to identify and complete the necessary testing, including the time that will be needed to design and review protocols, design testing schemes, review and interpret the data and finalize the study report,” the organizations say. “Given this, we believe it is crucial to obtain early and ongoing FDA input on the testing protocols and whether they sufficiently address the requirements that FDA set forth in the proposed rule.”

Should FDA deny industry’s request or ultimately determine that safety and efficacy data for antibacterial soap actives are insufficient to establish GRASE, many manufacturers will be obligated to reformulate and/or relabel products, adding to costs that industry estimates will far exceed FDA’s initial projections ([A#05140623004]).

As well, reduced availability of antiseptic wash products could result in 7.5 million new cases of foodborne illness, according to PCPC and ACI.

Industry Groups Need FDA Input On Antibacterial Ingredient Studies

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