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Cleaning‑product group warns Congress about 'free‑rider' problem for antiseptic studies and flags California bill
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Summary
Representing antiseptic suppliers, the American Cleaning Institute told the subcommittee that ACI members are funding costly safety studies requested by FDA while nonparticipating manufacturers benefit from the data; ACI suggested fee or exclusivity changes and urged more timely FDA communication in light of state bills such as California AB 916.
The American Cleaning Institute (ACI) told the Energy and Commerce subcommittee that its members are spending significant sums to generate safety and efficacy data for topical antiseptic actives that FDA deferred for further study, but that the benefits of that research extend to non‑participating manufacturers who can continue to market products without paying for the studies.
Douglas Trautman, interim co‑CEO of ACI, described the ‘‘free‑rider problem’’: member companies are funding multiyear, multimillion‑dollar studies to satisfy FDA’s requests while other firms will benefit without contributing. He asked Congress to consider modifying facility or sponsor user‑fee treatment for companies that actively participate in data generation or to extend exclusivity periods for sponsors that fund the requested studies.
Trautman also warned that state legislation — citing California Assembly Bill 916, which would restrict certain antiseptic ingredients — can move faster than federal rulemaking and that clearer, timelier FDA communication about the status of deferred ingredients could reduce calls for state bans. ACI said the Federal Food, Drug, and Cosmetic Act contains preemption language that supports national uniformity for nonprescription drugs and that agency updates could reassure consumers.
Ending: ACI told the committee it will continue to supply data and urged congressional consideration of user‑fee or exclusivity adjustments and more regular FDA engagement to resolve deferred antiseptic monograph determinations without state patchworks.
