Saturday 18 November 2017

FDA $4.7 billion in budget – Focus on FSMA and Inspections in China

The U.S. Food and Drug Administration announced Wednesday it is requesting a budget of $4.7 billion in fiscal year 2014 (click here for the press release). The press release said industry user fees would fund “94 percent of the proposed budget increase,” including new fees to support the Food Safety Modernization Act (FSMA) and strengthen the FDA’s ability to oversee imported food. The other main focus of the budget request is an expansion of inspections in China. Below are the highlights from the budget proposal:

The FY 2014 request covers the period from Oct. 1, 2013 through Sept. 30. 2014. Highlights of the FDA FY 2014 budget include:

  • Transforming Food Safety: +$295.8 million ($252.4 million in User Fees / $43.4 million in budget authority) above the FY 2012 level will bolster the FDA’s efforts to build a strong, reliable food safety system. Most of these funds are needed to support implementation of the FSMA, which provides authorities and mandates for the FDA to build a modern, prevention-focused domestic and imported food safety system to protect the health of American consumers. The budget proposes a food facility registration and inspection fee and a food importer fee. The FDA is also proposing new user fees to support its cosmetic and food contact substance notification programs. The President’s budget proposes a fee to be paid by food importers that would both improve the safety of the food supply as well as ensure the smooth and predictable entry of safe foods into the United States, thus enhancing trade by domestic and overseas trading partners.

  • White Oak Consolidation: +$17.9 million above the FY 2012 level will support the outfitting and required certification and operation of the Life Sciences-Biodefense Complex (the FDA’s White Oak headquarters in Silver Spring, Md.) to carry out cutting-edge research to ensure that the FDA is providing the best possible oversight over its regulated products to protect the American public. This is a cornerstone of the FDA’s effort to modernize regulatory science and promote medical product innovation.

  • Food and Drug Safety Inspections in China: +$10 million above the FY 2012 level will support the FDA’s capacity to detect and address the risks of products and ingredients manufactured in China and to help assure that these products do not result in harm to Americans.

  • Medical Countermeasures (MCM) Initiative: +$3.5 million above the FY 2012 level will help meet America’s national security and public health requirements for MCM readiness. The additional resources in FY 2014 will support science and partnerships to improve MCM development timelines and the success rates for MCMs.

 

Many critics of the Food Safety Modernization Act claim the FDA lacks the resources to fund its new mandate. The budget proposal makes clear the FDA is relying on a policy of enforcing the new legislation to keep it funded. As we wait for the foreign supplier verification program and qualified importer rule manufacturers in China should see reason for concern. The FDA’s budget leaves no doubt the new rules under FSMA will impact Chinese imports. Expect the full range of FSMA rules to come to bear during inspections, not just rules related to imports. US importers should begin to examine how their Chinese suppliers can cope with the new scrutiny.

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