J&J Suggests Targeting OTC Monograph With Public-Private Initiative
This article was originally published in The Tan Sheet
Executive Summary
An FDA guidance provides the framework for J&J consumer business executives’ suggestions to improve the OTC drug review. A public-private partnership “is key to developing and delivering a comprehensive solution,” says Lynne Szczepaniak, regulatory affairs VP at J&J’s McNeil Consumer Healthcare subsidiary.
Johnson & Johnson recommends taking a page out of FDA’s playbook to improve the agency’s OTC monograph system with a public-private partnership similar to an initiative that spurred changes in children’s drug dosing and labeling.
A guidance for staff that FDA published in 2003 – “The Leveraging Handbook, An Agency Resource for Effective Collaborations” – provided the framework for suggestions J&J consumer business executives Lynne Szczepaniak and Ed Kuffner made in a presentation on March 26, the first of FDA’s two-day public hearing for comments on improving the OTC drug review.
FDA requested comments on the strengths and weaknesses of the OTC drug review and possible modifications or alternatives to the program in a Feb. 24 Federal Register notice. The agency is accepting comments on potential changes, including expanding the process for allowing deviations from drug formulations approved through new drug applications and issuing monographs by administrative order and on identifying a streamlined process that would allow prompt resolution of existing tentative final monographs (Also see "FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”" - Pink Sheet, 24 Feb, 2014.). Comments are due May 12.
“The very nature of the monograph system, where multiple companies market products with common ingredients and for common indications, lends itself well” a public-private, collaborative approach. “An ideal collaborative partnership would have the cooperation of all those with relevant data as well as the resources and expertise needed to complete this work.” – Lynne Szczepaniak, J&J/McNeil
Szczepaniak, regulatory affairs VP at J&J’s McNeil Consumer Healthcare subsidiary, said a collaborative public-private approach “is key to developing and delivering a comprehensive solution” to overhauling the monograph process.
FDA’s Leveraging Handbook gives guidance on “how best to utilize relationships to address public health challenges” and outlines “a step-by-step process for designing, forming and using collaborations,” she said.
Existing FDA-industry partnerships include the Sentinel post-marketing safety monitoring project for medical products. Sentinel was launched in 2008 to create a national integrated electronic system that allows the agency to access multiple data systems, such as insurance claims databases and medical records (Also see "Sentinel Will Benefit From Administration's Health IT Push" - Pink Sheet, 25 Jan, 2010.).
PROTECT Provides Model
FDA and the OTC industry also are participating in the Preventing Overdoses and Treatment Errors in Children Task Force, a Centers for Disease Control and Prevention-sponsored initiative to improve medication safety, including packaging mechanisms to prevent children from accessing drugs and an educational campaign to remind caregivers to keep drugs out of the reach of young children (Also see "Flow Restrictors Limit Children’s Access To Drugs; Standards Needed" - Pink Sheet, 31 Jul, 2013.).
Kuffner, McNeil Consumer’s VP for OTC medical affairs and clinical research, pointed out PROTECT’s work led to OTC firms incorporating flow restrictors in children’s products.
The initiative also influenced manufacturers’ decisions to voluntarily modify labels on children’s products to increase safe usage, spurred development of the Consumer Healthcare Products Association’s “Up & Away and Out of Sight” education campaign and encouraged additional research on safe medication use for children.
“These accomplishments would not have been possible without the sustained and focused collaboration that a public-private partnership fosters and facilitates,” Kuffner told the FDA panel.
PROTECT participants also include the American Pharmacists Association; American Academy of Pediatrics; American Association of Poison Control Centers; National Consumers League; Institute for Safe Medicine Practices; National Council on Patient Information and Education; pharmacy retailers; and the federal Consumer Product Safety Commission.
“The partnership brings together experts and stakeholders who might otherwise not want to … share learnings and coordinate efforts certainly to the degree that we currently see happening today in the PROTECT initiative,” Kuffner said.
“Just as protecting a child is a shared responsibility, so should be the efforts around the OTC monograph system and making it more agile and current. Both of those require creativity, collaboration and commitment. Our company would really welcome the opportunity to participate in such a public-private partnership on the OTC monograph and we believe that such a partnership really has the potential to benefit all stakeholders,” he added.
Ask Competitors To Cooperate
Szczepaniak suggested the market dynamic created by the OTC monograph system makes a collaboration modeled on PROTECT the most likely way to make progress on improving the system.
“The very nature of the monograph system, where multiple companies market products with common ingredients and for common indications, lends itself well to this approach,” she said.
“An ideal collaborative partnership would have the cooperation of all those with relevant data as well as the resources and expertise needed to complete this work,” she added.
However, while J&J and other drug firms manufacture and market similar products defined by OTC monographs, some firms might question entering collaborations with a requirement to reveal information their competitors might not have, but could be relevant to a monograph.
One impediment to completing the OTC monographs is the lack of data and other information from industry that FDA considers necessary to making decisions on what ingredients, formulations, dosing and usage directions and other information should be included in a monograph.
The question of firms providing more information arose numerous times during the two-day hearing, from speakers as well as from FDA officials listening to the presentations.
How can FDA “incentivize companies to provide the missing data needed to complete a monograph?” said Robert Guidos, a senior adviser in the Center for Drug Evaluation and Research and the presiding federal official for the meeting.
Deadlines generally are good incentives, said Barbara Kochanowski, CHPA’s VP of regulatory and scientific affairs. “I think the history says when we have a deadline to make a comment, information is forthcoming,” she said.
Recommendations to ask firms for narrowly focused information came from several speakers, including David Steinberg, president of Steinberg & Associates Inc., a regulatory consulting firm specializing in the OTC drug and personal care industries.
“When the FDA says we need more information, is it safety? Is it efficacy? Is it dose form? Define exactly what it is. … If it’s safety, what are the safety questions? If you say we do not have enough safety information, are you asking for the world, or are you asking a specific question?” he said.
“If the industry doesn’t have the information, they can run the tests. I think if we could narrow it down we’ll get a better response,” Steinberg added.
Step-By-Step Outline
FDA’s Leveraging Handbook includes a step-by-step “Developing Leveraged Projects” outline. The steps in the process that guided J&J’s recommendations are:
- define the public health issue the initiative will address
- define the purpose, goals and anticipated benefits of the project
- describe the actions needed to address the public health issue
- identify potential collaborators
- select the best leveraging mechanism for the project
Szczepaniak said following those five steps could launch FDA and the industry in a partnership for completing the OTC drug review.
She said FDA answered the first step in the Federal Register notice announcing the hearing, which “stated that a more agile and more responsive [OTC monograph] process is needed in light of the rapid evolution of science today.”
Szczepaniak said the Federal Register notice also defines the second step’s request for goals: finalize the pending or tentative final monograph; ensure the ability to respond promptly to emerging safety and efficacy data; and improve FDA’s ability to allow certain label change to drug products.
Step three “is where the public-private partnership starts,” she added. That is because this step would require participants to reveal their strengths and weaknesses in terms of providing information needed to complete a monograph.
“At the moment no single stakeholder holder [is] able to see the full range of experiences, challenges and obligations of all stakeholders. And yet, that’s what it will take to provide a comprehensive, transformative and adaptable solution,” Szczepaniak said.
The FDA guidance states step four comprises considering whether entities identified as potential initiative participants “are able to offer the needed capabilities and are likely to have compatible incentives and goals.”
Kuffner told the panel that compatibility should not be a problem among participants in a public-private partnership targeting the OTC drug review.
“There’s no question in the end we all want the same thing. We want a system that is stronger, that’s more efficient and one that keeps the focus on what’s really important, and that’s really patients and caregivers and consumers,” he said.
Executing the fifth step in the FDA guidance involves choosing a leveraging format that determines whether costs are shared between participating public and private entities, or one side or the other foots the bill. The leveraging formats also determine how information is shared and how an initiative’s results are used.
“Johnson & Johnson is committed to working with FDA, industry and other stakeholders to complete these steps. We will actively explore the interest in and feasibility of a public-private partnership focused on the OTC monograph process,” Szczepaniak said.