ACI Urges FDA Fee Modifications and More Efficient Agency Communication

The American Cleaning Institute (ACI) has called for incentivizing industry buy-in for finalizing Generally Recognized as Safe and Effective (GRAS/E) determinations and greater clarity and timeliness of communications from the Food and Drug Administration (FDA).

The US Senate Committee on Health, Education, Labor and Pensions (HELP) Committee heard testimony from FDA about the reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). ACI is encouraging committee members 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 FDA deferred four topical antiseptic ingredients – ethanol, benzalkonium chloride, benzethonium chloride, and chloroxylenol – from final rulemaking under the Over-the-Counter Drug Review and requested additional studies to evaluate their safety and effectiveness. ACI and a subset of its members are funding a multi-year, multi-million-dollar research effort to meet FDA’s requirements on the safety and efficacy of key ingredients used in healthcare and consumer hand hygiene antiseptic products.

“Under the current system, ACI member companies are shouldering all the data costs,” ACI Interim-Co Chief Executive Office Doug Troutman wrote. “However, the benefits derived from that data will support the continued marketing by all antiseptic manufacturers, including non-participating companies.”

To address this issue, Troutman recommends considering modifications to user fees for sponsors that actively participate in the data generation process, and 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 the regulated industry attempting to address the agency’s questions.

“ACI believes that more timely communications by FDA to drug manufacturers and the public are needed to continue progress,” added Troutman, who also serves as ACI’s general counsel and senior vice president, government affairs. “Better public understanding would be strengthened by increased FDA communication.”