ACI Pushes for FDA Crackdown on ‘Free-Riders’ Benefitting from Companies Funding Required Research

The American Cleaning Institute (ACI) is asking the Food and Drug Administration (FDA) to 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.

The American Cleaning Institute petitioned this 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 senior vice president, 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: Modify facility or user fees for sponsors that actively participate in the data generation process; or extend 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.”