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Letter From The Editor: His food safety budget is Gottlieb’s departing legacy

This is one of those “in-the-news” stories that you might not be expecting. Federal food safety appears to be on the precipice for its best budget year in its history.
That possibility is contained in 2020 budget submitted to Congress by the White House. The Food and Drug Administration (FDA) is on a short list of domestic programs proposed go get budget increases.

Rather dramatic increases, in fact. If accepted by Congress, the FDAs payroll will grow by 455 to 18,052.Its total discretionary budget authority will reach $3.3 billion, an increase of $362 million.FDA food safety will increase by $52 million for a total of $1.122 billion.Putting aside food safety for a moment, the FDAs year-to-year gains in other areas are also dramatic. Its human drugs area rises by $266 million for a total of $1.98 billion. Biologics rise to $52 million; animal drugs and feeds, up $19 million; medical devices,$109 million more; and tobacco products, climbing $135 million.

FDA Commissioner Scott Gottlieb must get some of the credit for getting the submission delivered to Congress. His budget-writing success makes his surprise departure from the administration all the more curious.Some credit should probably also go to the Beltway-based Alliance for a Stronger FDA. In its own Washington D.C. words, the Alliance is a multi-stakeholder advocacy group that unites more than 150 patient and consumer groups, biomedical research advocates, health professions societies, individuals and industry to work to increase FDAs budget authority appropriations.That mouthful aside, The Alliance in the past decade has emerged as a force in the FDAs budget process. Between the executive budget writers and Congressional committees and staffs, it takes iron pants to follow the process from beginning to end.When the White House dropped the 2020 budget, Gottlieb and Deputy Commissioner Frank Yiannis issued a wordy joint statement boosting how the 2020 budget with funding for new resources and staff will allow FDA to enhance signal detection, response to outbreaks, and post-response evaluations.They explained how whole genome sequencing (WGS) is a game-changer.

generating more food safety investigations involving foods contaminated by pathogens.FDAs budget arguments are always better when the agency and its advocates can put numbers together with an effective verbal pitch.The budget submittal has $16 million to improve signal detection of foodborne illness and strengthen the response to food contamination. Another $16 million in new money will go for state cooperative agreements to conduct inspections; and $36 million for review human food ingredients.It unclear who at FDA will be responsible for getting the 2020 budget across the Congressional finish line now that Gottlieb is to be gone.The National Cancer Institutes Ned Sharpless is taking over as FDA Commissioner at least on a temporary basis.

Hes a fan of Gottliebs aggressive style and is a good bet for the job on a long-term basis.But the White House cut $900 million from the NCIs proposed 2020 budget, supporting increases only for childhood cancer.As promising as it Looks for FDA, it is still going to be a lengthy budget process.Food safety across all FDA programs will total $1.4 billion, an increase of $67 million over the fiscal year 2019. That includes $44 million in user fees.FDA has made the jump from building the regulatory framework to support the Food Safety Modernational Act of 2011 to enforcement.Congress passed the FSMA to prevent foodborne illness, not just respond to it.Theres been doubt about whether Congress would cash that check when it came due.   The outgoing FDA Commissioner has found a way to call those Congressional cards.

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