Tag Archives: HHS

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Expert Panel Recommends a New Federal Food Administration Separate from FDA

By Food Safety Tech Staff
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On December 6, the Independent Expert Panel for Human Foods submitted its Operational Evaluation of FDA’s Human Foods Program report to Dr. Robert Califf, FDA Commissioner for Food and Drugs. The evaluation and report, which addressed culture, structure/leadership, resources, and authorities, were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.

The panel, chaired by former Commissioner of Food and Drugs Dr. Jane Henney, highlighted several concerning findings in their report, including lack of communication, lack of a clear vision and mission, lack of a clear, overarching leader, and siloed workers within the FDA’s Human Foods program. Its recommendations to improve both food safety and nutrition in the U.S. included creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.

Notably, the panel found that the FDA Human Foods program was ill defined with multiple agencies, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information.

“The current structure of the FDA Human Foods Program reinforces duplicative or competing roles and responsibilities, siloed work, and inadequate internal and external engagement. This reality impedes the Human Foods Program move toward a prevention paradigm. While a change in structure cannot address all the challenges identified through this Human Foods Program review, changing the current organizational configuration will assist the Agency in advancing its mission,” the panel wrote.

In addition to Dr. Henney, the panel included Francisco Diez-Gonzalez, PhD, James Jones, Barbara Kowalcyk, PhD, Shiriki Kumanyika, PhD, MS, MPH, and John Taylor, JD. The team of researchers, former regulators, and process improvement specialists used a three-phase evaluation protocol consisting of information gathering, information synthesis and analysis, and report generation. The panel heard from more than 350 stakeholders through a two-day in-person stakeholder meeting, an online stakeholder public portal, and a series of interviews.

“We were honored to take on this challenge and worked diligently to propose changes to strengthen the operation of FDA’s Human Foods Program,” said Dr. Henney. “The report provides constructive recommendations that will take time to work through and implement, but we are confident the effort will benefit the health and safety of the American public.”

Read the full report here.

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Why One Former FDA Food Commish Thinks the Food Program Needs Its Own Agency

By Food Safety Tech Staff
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FDA

In an Op-Ed published by Politico today, former FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor is calling on FDA’s Food Program to be separated from the current hierarchy—with the establishment of a new agency that has its own head and reports directly to the HHS secretary.

“Under FDA’s current structure, no one is really in charge and realistically accountable for the food program’s strategic direction, sound resource management and overall success; and this state of play has real consequences for consumers. It puts at risk the public’s health and consumer confidence in the nation’s food supply,” Taylor wrote in “It’s Time to Fix FDA by Breaking It Up”. He emphasizes that food has not been given a high enough priority at the agency, despite the passage and implementation of FSMA, and the past two administrations did not help either. “Neither the Obama nor Trump administration empowered the deputy commissioner for food to oversee the program’s largest organizational unit, which is responsible for food inspection and import activities and manages nearly 70% of all the dollars Congress gives the food program,” he stated. “The success of food safety modernization won’t succeed without the policymaking and inspection units working as an integrated whole. Because they are all managed separately and report directly to commissioners whose attention is elsewhere, this is virtually impossible in today’s FDA.”

Allowing the Food Program to stand on its own, reporting directly to HHS, would create an agency that is empowered not only with more resources but also with having more accountability.

FDA

President Trump to Nominate Stephen Hahn as Next FDA Commissioner

By Food Safety Tech Staff
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Today The White House issued a statement in which President Trump announced his plan to nominate Stephen Hahn, M.D. to the position of FDA commissioner. Hahn is a radiation and medical oncologist, and currently serves as the chief medical executive at The University of Texas MD Anderson Cancer Center in Houston.

According to The Washington Post, current Acting FDA Commissioner Ned Sharpless will return to his position as director of the National Cancer Institute while HHS official Brett Giroir will step in at FDA until Hahn is confirmed.
The Post reports that Sharpless’ term ends Friday, and it could only be extended if the White House named a successor—however, the White House cannot do so because paperwork has not been completed.