FDA Can't Implement FSMA Without Funding Increase, Says Acting Commissioner
Acting Food and Drug Administration Commissioner Stephen Ostroff on Feb. 25 called on House appropriators to fully fund the agency’s fiscal 2017 budget request, saying that FDA couldn’t implement the Food Safety Modernization Act without the additional $211.6 million requested for food safety. “Now that the rules are final, this is a make-or-break year for FSMA,” Ostroff said during an FDA budget hearing hosted by the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies. “Without full funding, FDA would be unable to put into place the necessary programs, standards, and oversight, and to bring the FSMA from a concept to reality.”
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FDA received $1.3 billion for food safety for the current fiscal year. Ostroff added that the additional fiscal 2017 funding will help importers prepare to implement FSMA rules, and will aid the success of FDA’s Foreign Supplier Verification Program. The Senate on Feb. 24 confirmed Robert Califf as the next FDA commissioner (see 1602240028), but Ostroff said a swear-in date has not been set yet.
Before Congress appropriates the FDA's requested fiscal 2017 funding, the agency should provide “proper accounting” for food safety expenditures for fiscal 2016 and the past few years, said Subcommittee Chairman Robert Aderholt, R-Ala. “Since FDA is informing Congress that Food Safety, Medical Product Safety, and Rent and Infrastructure needs are their highest priorities this year, it will be incumbent upon FDA to prove to Congress that such priorities cannot be funded out of base resources first,” Aderholt said. “In addition, the Agency must demonstrate that all efforts have been made to review current operations for any additional savings and efficiencies.” The chairman said this is especially important, in part, because FDA has budgeted $202.3 million in new, unauthorized user fee programs, yet has not demonstrated their helpfulness for intended beneficiaries.
As FDA closes in on releasing a final rule on electronic cigarettes, Ostroff said the final version has received interagency and White House approval, and the FDA is merely putting finishing touches on it. FDA in 2014 proposed more stringent restrictions on cigars, e-cigarettes and other tobacco products by bringing them under the regulatory scheme of the agency’s cigarette and smokeless tobacco regulations, an action which could add new requirements for importers (see 14042426). Moving the products under tobacco regulations would legally entail registration requirements, FDA review, and health warning labels.