- At Congressional Hearing, ACI Highlights Research Efforts to Meet FDA Requirements on Antibacterial Soap Safety Efficacy
- Also Urges Agency to Improve Communications, Response Efforts with Manufacturers Providing Research Updates
The Food and Drug Administration (FDA) should consider options that would protect manufacturers who invest in research to help meet the agency’s data requests from ‘free-riders’ who benefit from the results of that work without paying a dime.
That was the message delivered by the American Cleaning Institute (ACI) before a congressional subcommittee examining the FDA’s regulation of over-the-counter (OTC) monograph drugs.
ACI and a subset of its members are funding a multi-year, multi-million-dollar research effort to meet FDA’s stringent requirements on the safety and efficacy of key ingredients used in healthcare and consumer hand hygiene antiseptic products.
To-date, ACI has submitted multiple reports to the agency showing ongoing progress to satisfy FDA’s requests. Filling those data gaps are very costly and highly resource intensive over time, according to testimony from Douglas Troutman, ACI’s Interim Co-CEO, at a hearing held by the House Energy and Commerce Subcommittee on Health.
“Filling those data gaps are very costly and highly resource intensive over time. However, the ACI member companies funding the requested studies are a fraction of the antiseptic market that will ultimately benefit from the data,” said Troutman, who also serves as ACI’s General Counsel and SVP, Government Affairs.
“In short, ACI member companies are shouldering all the data costs. The benefits derived from the data will support the continued marketing by all antiseptic manufacturers including non-participating companies.”
Troutman offered two options to consider as solutions: Either modify facility or user fees for sponsors that actively participate in the data generation process; or extending, or at the very least maintaining, the exclusivity period for manufacturers that invest in the research. That period is currently set at 18 months.
ACI also called for more timely and productive communication from FDA, especially to regulated industry attempting to address the agency’s questions.
“ACI believes the Agency should prioritize resources to facilitate greater informal FDA feedback and collaboration with manufacturers to optimize and complete the requested studies, make a Generally Recognized as Safe and Effective (GRAS/E) determination, and educate the public on progress being made by manufacturers towards completing the studies,” said Troutman.
“More timely and productive communication from the FDA on GRAS/E studies to both manufacturers and the public would enhance this progress.”
“Greater clarity and timeliness of communications from the FDA are needed, given that States are undertaking their own initiatives regarding three of the legally deferred ingredients,” added Troutman, citing current California legislation that seeks to ban effective antibacterial soap ingredients that are lawfully marketed under FDA rules.
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.