There is nothing wrong with FDA’s over-the-counter drug monograph system – as designed – but marked improvements are needed for the system to function at a level that promotes industry and consumer confidence, leadership from the Personal Care Products Council says.

In comments offered at a March 25 public hearing held at FDA’s White Oak campus in Silver Spring, Md., Elizabeth Anderson, PCPC’s executive VP-legal and general counsel, emphasized that the OTC drug monograph system is “an appropriate and rational framework for regulating cosmetic-drug products,” including cosmetics with SPF, antiperspirants, anti-dandruff shampoos and oral-care products.

However, “the OTC monograph system needs to be more agile and responsive. It is not making sufficient progress,” she said.

FDA’s monograph system for OTC drugs was established in the 1970s as a three-phase public rulemaking process that identifies active ingredients and conditions deemed generally recognized as safe and effective (GRASE) for specific OTC therapeutic drug classes. In concept, the mechanism provides OTC drug manufacturers with an authorized route to market without investing in a costly and time-consuming New Drug Application.

In practice, the system has been fraught with delays and other challenges that have stakeholders and FDA looking for answers. The agency convened the March 25-26 hearing to garner input on how the process might be improved and the feasibility of potential changes it is exploring ([A#02140303007]).

Anderson suggested in her testimony that industry and other stakeholders may be served best by hearing more from FDA on the subject.

“We believe the OTC process should be implemented as originally intended in the early 1970s – to be flexible and adaptable. What are the challenges the FDA is facing? What is preventing this from happening?” she asked.

In her remarks, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, offered some perspective on the challenges the agency faces in finalizing monographs, with 25 of 80 planned monographs stalled at the tentative final rulemaking stage. She suggested that clearing the monograph queue under the current framework in the near term is beyond FDA’s capabilities as mounting regulatory demands continue to stretch the agency’s limited resources ([A#02140331003]).

Industry Holding Up Its End

The OTC sunscreen monograph is widely viewed as a prime example of the system’s failure. Indefinitely stayed in 2001 to allow for data collection and related rulemaking, the final monograph for sunscreen products has yet to go into effect, despite persistent pressure from Congress and consumer advocacy groups. In the interim, the agency has resolved to use enforcement discretion with regard to marketed sunscreen products, an approach that is not always understood or seen as sufficient by public watchdogs.

Anderson noted that “the fact that many OTC products have remained safely on the market pending finalization of their monograph can sometimes be difficult to explain to consumers.”

In its 2013 annual Sunscreen Guide, the Environmental Working Group linked a perceived dearth of safe and effective sunscreen products to FDA’s inadequate regulation of the category Also see "Most U.S. Sunscreens Not So Hot, Reflecting FDA Failures – EWG" - HBW Insight, 27 May, 2013..

Sluggishness in the OTC drug monograph process and a lack of visibility into FDA’s related rulemaking also “creates regulatory uncertainty for manufacturers and hampers innovation and investment,” according to Anderson.

She summed up industry’s view on the system: “Often, it’s a stop-and-start process. There’s a lot of activity, and then years of seeming inactivity before it starts up again.”

The hiccups do not seem to correlate with data gaps and cannot be attributed to insufficient industry participation, she said.

“Industry has been responsive to requests for data and information. In fact, informally, FDA acknowledges the dockets are full – containing data and information submitted over several years.”

More Frequent Communication Needed

Anderson noted that greater insight into FDA’s process and the challenges the agency faces would better enable industry to help improve the OTC drug monograph system’s efficiency.

She proposed more frequent communication between FDA and interested parties throughout the agency’s rulemaking process. “Too often industry has submitted new data or responses to requests for information and then not heard back from the agency.”

Anderson continued: “Engaged and active thinking occurs in conversation – spoken or in written correspondence – ideally both. This lack of communication does not serve FDA or other agencies involved in the rulemaking process; as time lapses personnel change, the science may change or evolve. Issues do not get resolved and remain.”

In the interest of greater transparency, FDA should work to ensure that the status of proposed rules is “up-to-date and clear, with sufficient information to the public at any time,” and the agency’s regulatory agenda and other timetables “should reflect realistic timeframes,” according to Anderson.

FDA’s unified agenda posted in early 2013 included rulemaking targets related to the OTC sunscreen monograph that were never met, an occurrence that has become more the norm than an exception Also see "FDA Regulatory Agenda Targets Antimicrobial Hand Washes, Sunscreen" - HBW Insight, 14 January, 2013..

A November 2013 consent decree issued under a settlement between FDA and the Natural Resources Defense Council requires the agency to finalize by specified deadlines a subsection of its monograph for OTC topical antimicrobial drug products focusing on triclosan use in hand-wash items, thereby addressing what has been a prominent public concern for years Also see "Consent Decree Orders FDA Action On Triclosan OTC Monographs" - HBW Insight, 9 December, 2013..

Transparency, Communication Needed In OTC Monograph System – PCPC

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