FDA Enters Into Consent Decree; Agrees to Timely Complete Triclosan OTC Drug Antiseptic Monographs

By Kurt R. Karst –      

After more than three years of litigation that started with a July 2010 Complaint filed in the U.S. District Court for the Southern District of New York (see our previous post here), and that went up to the U.S. Court of Appeals for the Second Circuit (see our previous post here), the Natural Resources Defense Council (“NRDC”) recently announced that FDA agreed to finalize its topical antimicrobial drug products Over-the-Counter (“OTC”) drug monograph with respect to triclosan.  The agreement comes in the form of a Consent Decree in which FDA agreed to timetables for completing action on various topical antimicrobial drug product monograph subcategories involving triclosan: Consumer Antiseptic Hand Wash Products Monograph; Healthcare Antiseptic Products Monograph; and Consumer Antiseptic Hand Rub Products Monograph.  (These subcategories are laid out by FDA in a Declaration submitted to the district court in August 2013 explaining the Agency’s plans for the topical antimicrobial monograph.) 

The use of triclosan in OTC drug products, such as in soaps and hand sanitizers, has been controversial.  It has been alleged by some – including the NRDC and some Members of Congress (here and here) – to be an endocrine disruptor that has been linked to reproductive and developmental harm. 

As we previously reported (here and here), the NRDC initially alleged that FDA has unreasonably delayed in violation of the Administrative Procedure Act the publication of a final OTC drug monograph with respect to both triclosan and a related ingredient, triclocarban.  FDA challenged the NRDC’s standing to sue in this matter, and in January 2011, the New York District Court ruled from the bench granting FDA’s Motion to Dismiss for lack of standing.  The NRDC appealed that decision to the Second Circuit, which vacated that decision in March 2013 with respect to triclosan (but not triclocarban) and remanded the case to the district court for further proceedings.  The NRDC subsequently filed an Amended Complaint limited to triclosan. 

At a July 19, 2013 status conference before district court Judge Alvin K. Hellerstein, FDA agreed to submit a specific, non-binding timetable for completing its regulation of triclosan.  That ultimately led to the Consent Decree, which includes the following terms (timetables) for addressing triclosan in OTC drug products:

a. Consumer Antiseptic Hand Wash Products Monograph

i.  Publication of tentative final monograph.  December 16, 2013

ii. Comment period for tentative final monograph.  June 16, 2014

iii.  End of period to submit new data and information for tentative final monograph.  December 16, 2014

iv. Rebuttal comment period for tentative final monograph.  February 17, 2015

v. FDA review of comments, data, and information; drafting of the final monograph; and final review and approval by FDA, Department of Health and Human Services, and Office ofManagement and Budget.  August 31, 2016

vi.  Publication of Final Monograph.  September 15, 2016

b. Healthcare Antiseptic Products Monograph

i.  Publication of tentative final monograph.  April 30, 2015

ii.  Comment period for tentative final monograph.  October 31, 2015

iii.  End of period to submit new data and information for tentative final monograph.  April 30, 2016

iv. Rebuttal comment period for tentative final monograph.  June 30, 2016

v. FDA review of comments, data, and information; drafting of the final monograph; and final review and approval by FDA, Department of Health and Human Services, and Office of Management and Budget.  December 31, 2017

vi.  Publication of Final Monograph.  January 15, 2018

c.  Consumer Antiseptic Hand Rub Products Monograph

i.  Publication of tentative final monograph.  June 30, 2016

ii.  Comment period for tentative final monograph.  December 31, 2016

iii.  End of period to submit new data and information for tentative final monograph.  June 30, 2017

iv. Rebuttal comment period for tentative final monograph.  August 31, 2017

v. FDA review of comments, data, and information; drafting of the final monograph; and final review and approval by FDA, Department of Health and Human Services, and Office of Management and Budget.  March 31, 2019

vi.  Publication of Final Monograph.  April 15, 2019

In addition, FDA agreed to submit to the district court and to the NRDC status reports every 6 months (until each monograph is completed) containing a description of the actions taken by FDA to meet the terms of the Consent Decree during the previous 6 months, and what actions the Agency intends to take during the next 6 months.

Although the Consent Decree applies only to triclosan OTC drug monograph proceedings, it seems highly unlikely that FDA will limit work on these monographs to that condition.  Instead, FDA will likely work to complete them in their entirety.

The NRDC case is not the first time FDA has been sued – or otherwise pressured – to take action on long-pending administrative actions.  As we previously reported, the NRDC successfully sued FDA over the Agency’s failure to take action to withdraw approval of certain uses of certain classes of antibiotics in food-producing animals pursuant to notices FDA issued in 1977.  In addition, in the OTC drug arena, Congress has had to step in to pressure FDA to take action with respect to sunscreen drug products (see here and here).