Food Safety

FDA on Friday (March 15) finalized a rule that pushes back deadlines for farms to comply with agricultural water standards required in the Food Safety Modernization Act, despite calls from food safety advocates for the agency to implement interim rules to help prevent future foodborne illness outbreaks, such as the 2018 romaine lettuce E. coli outbreaks.

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives.

FDA Commissioner Scott Gottlieb and Deputy Commissioner for Food Policy and Response Frank Yiannas on Monday (Feb. 25) promoted the agency’s food safety goals and programs in a statement that one food safety advocate believes is largely aspirational, as the agency does not have additional resources to help staff its foreign offices and conduct more import inspections.

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.

A week after the temporary end of a month-long partial government shutdown, the stakes are high for FDA as lawmakers and the White House resume talks on a possible deal to fund the government when the short-term spending bill ends Feb. 15.

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

As the partial government shutdown hits its third week, 33 Senate Democrats penned a letter to FDA Commissioner Scott Gottlieb on Friday (Jan. 11) asking the agency chief how his staff has scaled back oversight of food and medical products; how a shutdown could hinder approval of new medical products and what the agency is doing to address the financial hardship of its staff, 41 percent of whom are furloughed.

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.