In the announcement, Gottlieb also explained that evaluations of potential OTC naloxone applications might proceed slowly because FDA currently doesn't have a fiscal year 2019 appropriation. The federal government is in the fourth week of a partial shutdown due to an impasse on FY 2019 spending as Democrats in Congress oppose President Trump's insistence on including at least $5bn to pay for a security wall at the Mexican border.

Evaluations of NDAs and other applications for naloxone and other drugs requiring pre-market approval are supported by user fees, but FDA doesn't have access to fees that would be included in its FY 2019 budget.

Its reviews of existing medical product applications and associated policy development currently "are funded by limited carryover user fee balances," Gottlieb said. "We'll continue to update the public on how we're approaching our work during the lapse in appropriations."

Earlier in January, Gottlieb said in a Twitter social media post that the agency's first user-fee carryover balance likely to be exhausted is that for NDAs and it already had stopped accepting the majority of submissions. Nearly 60% of the agency's workforce is furloughed due to the shutdown. (Also see "FDA Stretching Available Funds, Skeleton Workforce In Gov Shutdown Week Three" - HBW Insight, 10 January, 2019.)

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