Neither consumer groups nor industry representatives believe FDA plan will work

Leaders from a group of consumer and industry organizations were unanimous yesterday in condemning FDA Commissioner Robert Califf for his plan to restructure the agency.

To a person, the leaders said they were disappointed with Califf’s plan, which he said a month ago and again yesterday would include the creation of an “empowered” deputy commissioner for foods.

While Califf’s plan does include the creation of that post, it continues to have three separate divisions reporting directly to the FDA commissioner, continuing the silo and matrix situation that the industry and consumer groups say endangers the public in terms of food safety.

Roberta Wagner from the Consumer Brands Association said her years of experience at the Food and Drug Administration showed her that the matrix approach does not work for the food side of the agency. She said instead of taking the advice from an external review by the Reagan Udalll Foundation and recommendations from an internal FDA review, Califf is choosing to go with the status quo.

“The commissioner must relinquish control,” said Wagner.

Brian Ronholm of Consumer Reports, who served in the USDA’s Food Safety and Inspection Service for part of his career, said with Califf’s new plan the agency is failing to take a straightforward approach to problems identified in the two reviews Wagner referenced. Ronholm said the plan set forth by Califf repeatedly refers to an empowered deputy commissioner of foods but fails to give that post the ability to take control of and responsibility for the food side of the agency.

“The deputy commissioner must have direct authority,” Ronholm said, “but two-thirds of the food safety budget is not under the purview of the deputy commissioner (under this plan).”

Ronholm said it is not a question of if, but when, there will be another food safety crisis such as was seen a year ago with infant formula when problems with the chain of command came to full light.

Mitzi Baum of STOP Foodborne Illness also referred to the infant formula crisis, which not only showed how a lack of a clear chain of command allowed a situation to continue that saw two babies die, but also led to months long shortages when a manufacturing plant was eventually shut down for investigation and cleaning.

“This is the one-year anniversary of the infant formula crisis yet the commissioner continues to defy the advice (called for in the reviews),” Baum said.

Baum also called on the commissioner to be proactive in implementing changes outlined in the Food Safety Modernization Act. Calif has not mentioned the Act in his plans.

Steven Mandernach, leader of the Association of Food and Drug Officials, said Califf’s plan to add a deputy commissioner of foods is what is needed, but that the commissioner is going exactly in the opposite direction despite his promises. Mandernach said that the rough draft of a job description for the deputy commissioner post will make it impossible to recruit anyone qualified for the job.

“They will think ‘what am I getting into,’” he said.

Mandernach also pointed to the lack of urgency shown by Califf in his handling of the situation. It has taken a year so far for a bare bones plan to be developed and Califf said the FDA won’t be able to publish anything on it until at least fall. Then more reviews will be needed before the plan would be enacted.

“That’s two years before any change,” Mandernach said.

From the industry side, representatives from the American Frozen Food Institute (AFFI) and the International Fresh Produce Association (IFPA) were in lock step with the consumer advocates in terms of the impotent deputy commissioner post described by Califf. 

Donna Garren of AFFI said she was disappointed in the commissioner’s plan and that it will allow FDA to continue to operate by committee instead of introducing a clear line of command and the authority to make decisions that a truly empowered deputy commissioner would have.

“It just kicks the can down the road to the fall,” Garden said.

Jennifer McEntire of IFPA had almost identical comments. She said the commissioner had the opportunity for a litmus test but didn’t take it. She repeated what every other panelist had said regarding the lack of a clear chain of command under Califf’s plan.

Ronholm said there is bipartisan support for a deputy commissioner of foods and that the concept has been “gift-wrapped” for Califf.

“Still, the FDA is not acting on it,” Ronholm said.

In the past month, Califf met with members of the coalition of consumer and industry groups, but those members said the meeting wasn’t productive. Ronholm said rather than the meeting being an exchange of ideas, it was a situation where the government “just told us” how things would be.

Garren echoed Ronholm’s comment saying that the commissioner has said he wants their input but is keeping them at arm’s length.

“We deserve a seat at the table instead of being the meal on the table,” she said.

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