Consumer groups call on FDA Commissioner to restore teeth to agency’s leadership

Editor’s notice: Following is a letter despatched by Shopper Experiences and a coalition of involved entities (see listing under) concerning the management on the Meals and Drug Administration in reference to the latest Reagan-Udall Foundation report on the company.

Dr. Robert Califf Commissioner
Meals and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903-0002

We write to share our feedback and ideas concerning your subsequent steps primarily based on the evaluation and proposals from the Knowledgeable Panel convened by the Reagan-Udall Basis, and request a gathering as quickly as doable to debate them with you.

As a various coalition of FDA stakeholders, we thanks for commissioning the Basis’s impartial skilled evaluation of the Human Meals Program within the Meals and Drug Administration (FDA). The Knowledgeable Panel critically thought-about the enter it acquired from each exterior stakeholders and inside meals program workers in producing a candid report.

We imagine the Knowledgeable Panel report the Basis issued on December 6 precisely captures the issues involving the construction, management, tradition, transparency, and accountability throughout the FDA’s meals program, all of that are stopping the company from doing its finest to guard customers and allow business to innovate. We additionally admire the Knowledgeable Panel’s conclusion that having a single chief who’s empowered and accountable for the success of the meals program is central to its success; it’s noteworthy that the entire panel’s choices for structural change embrace this vital aspect. We additionally agree with the Knowledgeable Panel’s recognition that the inspection and compliance features of the Workplace of Regulatory Affairs (ORA) must be built-in with the policymakers that reside within the FDA’s Facilities.

We proceed to imagine that the choice of putting an empowered meals skilled in a deputy commissioner place with line authority over all components of a unified Human and Animal Meals Program is the vital aspect of a profitable organizational and management construction. We additionally acknowledge {that a} vary of choices for doing that is on the desk, all of which warrant dialogue.

For instance, whereas we predict possibility E (an empowered deputy commissioner) is the best and most expedient option to obtain the wanted structural and management change, Choices A and B additionally deserve dialogue and consideration. We don’t take into account Choice C — the CFSAN director and a political appointee main the meals program — to be viable as a result of nobody individual would have the bandwidth to each handle CFSAN and supply administration oversight of CVM, meals components of ORA, and presumably a brand new Heart for Vitamin.

Furthermore, below Choice C, operational management of this system would stay divided and probably politicized by an appointee within the commissioner’s workplace. Altering appointees and/or vacancies within the place would even be detrimental to this system. Lastly, we don’t take into account Choice D — counting on the commissioner and an advisor in his workplace to offer the sustained, integrative management this system wants — to be a viable possibility as a result of great competing calls for on the commissioner’s time.

We urge you to announce your dedication to an empowered deputy commissioner mannequin (Choice B or E) in February, and title an skilled meals security chief who may start serving in that function instantly on an appearing foundation whereas deliberations and dialogue proceed on how finest to implement such a mannequin. This might expedite FDA’s reform course of whereas additionally balancing urgency and the want for additional stakeholder dialogue. Formal reorganization of FDA will take time, however tradition change can and may start instantly.

We admire the sense of urgency mirrored in your intent to announce a brand new imaginative and prescient for the Meals Program by the tip of January and a brand new construction by the tip of February. Nevertheless, we urge you to noticeably interact exterior stakeholders – customers, business, and state and native companions – in real dialogue earlier than saying your determination.

The evaluation and proposals of the Knowledgeable Panel to determine the construction and management the meals program must be totally leveraged, and this may be achieved extra successfully by real dialogue together with your stakeholders.

Thanks in your consideration to this problem. We stay up for a gathering and additional dialogue with you as quickly as doable.


American Bakers Affiliation
American Frozen Meals Institute
Affiliation of Meals and Drug Officers
Heart for Meals Security
Shopper Federation of America
Shopper Experiences
Shopper Manufacturers Affiliation
Corn Refiners Affiliation
Environmental Protection Fund
Environmental Working Group
FMI – The Meals Business Affiliation
World Chilly Chain Alliance
Wholesome Infants Vibrant Futures
Worldwide Dairy Meals Affiliation Worldwide Recent Produce Affiliation Nationwide Confectioners Affiliation
Nationwide Grocers Affiliation
Nationwide Seasoning Producers Affiliation Pure Assets Protection Council
North American Millers’ Affiliation
Peanut and Tree Nut Processors Affiliation STOP Foodborne Sickness
Western Growers


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