- American Cleaning Institute Members Engaged in Multi-Year, Multi-Million Dollar Research Efforts to Meet FDA Data Requests on Topical Antiseptic Ingredients
- “Free Rider” Companies Not Engaged in Research Efforts Benefit Off the Backs of Those Investing in Science
- ACI Also Calls for Increased Transparency in FDA Review Policies
As the Food and Drug Administration (FDA) kicks off efforts that will determine user fees that fund the Agency’s review of nonprescription drugs, the American Cleaning Institute (ACI) urged regulators to confront the issue of “free riders”: companies that benefit off the backs of those who are funding research aimed at meeting FDA data requests, but who don’t participate in the research.
Background: A group of ACI members support a multi-year, multi-million dollar research effort to develop safety and efficacy data for topical antiseptic products like antibacterial soaps and hand sanitizers, in order to meet FDA’s regulatory requirements. ACI members continue to work diligently on the studies that FDA had requested to establish General Recognition of Safety and Effectiveness (GRASE) status for these drug products.
The issue at hand: The long-term commitments ACI and our members are making to fill the data gaps are very costly and resource intensive, said Douglas Troutman, ACI General Counsel and Senior Vice President of Government Affairs, at an FDA public meeting.
- “The companies participating in ACI’s studies represent only a fraction of the antiseptic active ingredient and formulated product manufacturers that will ultimately benefit from the data ACI members are generating.
- “With the way the monograph system works, even though our member companies are shouldering all of the costs, the benefits of the generated data will support the continued marketing of these antiseptic products by all antiseptic manufacturers, including non-participating companies.
- “We are concerned that the indispensable benefit conferred on non-members discourages participation in the data collection effort at a time when participation is critical to finalizing the regulatory status of topical antiseptics.
- “ACI encourages FDA to think critically about potential solutions to address this ‘free-rider’ problem and to incentivize industry buy-in for finalizing GRASE determinations. Options to consider include a waiver or reduction in facility fees or user fees for sponsors that actively participate in the data generation process and/or developing a cost-sharing or compensation system for free-riders to pay those who generate the data in exchange for the ability to sell their products in the U.S. marketplace.”
ACI also called for greater transparency in FDA processes governing dialogue with industry, as “understanding FDA expectations is critical for ACI and its members to continue making necessary investments to ensure topical antiseptic studies requested by FDA can be completed.”
Among the recommendations made by ACI:
- Maintain ongoing dialogue with industry through formal meetings and public hearings
- Prioritize resource allocation to provide timely communication and give sponsors flexibility in the ways they obtain FDA feedback
- More routine communications (e.g., email responses, letters, phone conversations)
- With respect to formal dispute resolution, cap number of appeals required before administrative hearing
- Clarify expectations for substantive contents of OTC Monograph Order Requests (OMOR) and standard of review
- Communicate with advance notice plans to initiate OMOR regarding GRASE status of active ingredients
The companies supporting ACI’s topical antiseptic research efforts use or manufacture the ingredients ethanol, benzalkonium chloride, benzethonium chloride, chloroxylenol, and povidone-iodine.
The American Cleaning Institute® (ACI – www.cleaninginstitute.org) is the Home of the U.S. Cleaning Products Industry® and represents the $60 billion U.S. cleaning product supply chain. ACI members include the manufacturers and formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical distributors. ACI serves the growth and innovation of the U.S. cleaning products industry by advancing the health and quality of life of people and protecting our planet. ACI achieves this through a continuous commitment to sound science and being a credible voice for the cleaning products industry.