https://www.cbsnews.com/news/fda-food-drug-inspections-layoffs/

Around 170 workers were cut from the FDA's Office of Inspections and Investigations, according to two federal health officials who were not authorized to speak publicly. 

The Department of Health and Human Services has said layoffs ordered by Secretary Robert F. Kennedy Jr., with some 10,000 workers let go from the department, would not directly cut FDA's inspections staff. But in meetings among federal health officials, the agency's remaining leaders have grappled with how to deal with major delays and disruptions caused by the loss of administrative and management staff who had supported the agency's inspectors, according to two FDA officials.

A “Transformative Initiative”

"These administrative functions are being streamlined as part of HHS' transformation initiative to make the agency more efficient and responsive. FDA inspectors were not impacted, and this critical work will continue," an HHS spokesperson said in a statement.

The inspections and investigations office will now need to work with FDA's drug, device and food centers to reprioritize their workload for the rest of the year, one official said. That will mean trimming routine "surveillance inspections" for more urgent tasks, the official said, like inspections of firms where the agency has been alerted to a safety risk or follow-up visits to ensure that drugmakers or food producers have fixed previous violations.

Elimination of FDA’s Travel Operations Division

One of the biggest immediate impacts on the agency's inspectors stems from the elimination of the office's travel operations division, one official said. The team's work ranged from booking flights to coordinating with the State Department to secure translators needed for inspections of drugmakers and food producers abroad.

"As of yesterday, all front-line investigators will now be spending significant time processing their own travel and related administrative requirements, rather than spending that time in firms ensuring the American consumer is protected," one FDA official said.

A pilot program of unannounced foreign inspections has also been paused due to the cuts, an official said, because of the loss of staff that had been tasked with quickly securing translators around the world.

Struggle to Meet Inspection Goals

The FDA has long struggled to meet its own inspection goals, which was worsened by a backlog created during the COVID-19 pandemic. According to a January report by the Government Accountability Office, the FDA was facing a swelling list of food safety inspections that were on track to miss deadlines mandated by Congress, as they struggled to hire and retain qualified inspectors. 

While current inspections are still taking place, multiple FDA officials said that cuts are likely to worsen delays caused by other challenges introduced by the Trump administration's efforts to cut spending in recent months.

As one example, multiple officials said that field operations have been hampered by a new government-wide $1 limit on spending cards. Any spending above that limit requires a cumbersome approval process. 

Inspectors had already been asked to plan their inspections a month in advance due to the delays caused by the spending limit, one official said. 

Note: In addition to the previous article, please see the following article for additional information regarding FDA cutbacks:

“FDA Planning to End Its Routine Food Safety Inspections”

https://www.cbsnews.com/news/fda-food-safety-inspections-plans/

Note: In addition to the following article, please see the accompanying video, “Maintaining the Safety of Our Food,” at the above-referenced internet address.

According to the article, the Food and Drug Administration (FDA) is drawing up plans that would end most of its routine food safety inspections work, multiple federal health officials told the media, and effectively outsource this oversight to state and local authorities.

The plans have not been finalized and might need congressional action to fully fund, said the officials, who were not authorized to speak publicly. 

"The claim that the FDA is suspending routine food safety inspections is false. FDA is actively working to ensure continuity of operations during the reorganization period and remains committed to ensuring critical programs and inspections continue," an FDA spokesperson said in a statement.

A Shift of Food Safety Responsibilities to the States?

Some FDA employees have been working on a possible shift of the agency's routine food efforts to states for years, one current and one former official said, which could free up resources to focus on higher priority and foreign inspections. The FDA already outsources some routine food inspections through contracts with 43 states and Puerto Rico. 

"There's so much work to go around. And us duplicating their work just doesn't make sense," one former FDA official, who worked on the plans before leaving the agency and spoke on the condition of anonymity, told the media.

Multiple federal health officials said that the state work currently is often reserved for lower-risk inspections. A third of routine food safety inspections were done by states over recent years, a Government Accountability Office report said earlier this year. 

The FDA’s Ultimate Responsibility

The FDA is ultimately responsible for the safety of much of the U.S. food supply that's distributed over state lines, like packaged products, seafood, eggs and produce. Some kinds of meat are regulated by a different agency inside the U.S. Department of Agriculture. 

Some higher-risk routine food inspections would likely remain at the FDA under the plans, two officials said. For example, agency staff currently conduct annual visits to infant formula manufacturers, which are overseen separately as "critical foods" inspections. States would also not be able to take on the work of routine inspections in foreign food facilities. 

It is unclear what would happen for the states that do not have contracts with the FDA to conduct food inspections, which range from Hawaii to Delaware. 

In addition to routine inspections, the FDA also does other kinds of inspections in response to issues, like a visit to a Colorado onion processor last year linked to the McDonald's Quarter Pounders outbreak that turned up dozens of violations. 

Internal planning around the possibility of outsourcing its routine inspections first picked up after 2010, the former FDA official said, when the agency was working on implementing major food safety legislation passed that year.

FDA’s Grade A Milk Safety Program

The official likened the plans to the FDA's Grade A Milk Safety Program, where states fund the majority of oversight work themselves and have agreements with the agency to standardize how the industry is regulated.  

Some states and advocacy groups have called for years for the FDA to move its routine food inspections out to states. States can often do inspections at a lower cost than the FDA, while meeting the same standards, they have argued.

"FDA audits have determined states inspections to be high quality, and the costs show them to be a good economic value. There is significant cost to managing two systems also," said Steve Mandernach, executive director of the Association of Food and Drug Officials, in a statement.

Mandernach drew a parallel to the Centers for Medicare and Medicaid Services, under which hospitals and nursing homes are largely inspected by state agencies but overseen by the federal government. 

He also pointed to how the FDA regulates produce farms. The FDA has agreements with most states to pay for routine inspections conducted by local agriculture departments, where they often handle inspections and enforcement themselves.

"Further, we implemented this type of program with produce already and it has been successful. Expanding and leveraging those lessons can only provide greater value to the taxpayers, increase oversight of manufacturers, and improve food safety," he said.

A Backlog of Inspections Overseas and for Medical Products

Ending the FDA's work to do its own routine food safety inspections might also help alleviate an issue elsewhere at the agency: a backlog of inspections overseas, as well as in other markets like medical products. 

In the past, FDA inspectors had been trained to do multiple kinds of inspections, officials said, instead of specializing only in food safety inspections.

Steep layoffs at the office's support staff is expected to result in cutbacks to the number of inspections that can be done by the agency, the media previously reported. FDA Commissioner Marty Makary has also greenlighted plans to hire contractors to attempt to plug the hole left by the laid-off workers.

"In theory, relying on states to do more routine food inspection work could lead to better food safety," said Thomas Gremillion, director of food policy at the Consumer Federation of America, in an email to the media. 

Gremillion cautioned that a transition in how food inspections are done by the FDA would take significant time and resources. 

"So far, this Administration has acted with reckless disregard for how its policies will affect the detection and prevention of foodborne illness, and any plans to replace federal food inspectors with some other workforce deserves suspicion," he said.

Discussion Questions

1. Describe the FDA, including its mission and its responsibilities.

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

The FDA is responsible for advancing public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

The FDA also plays a significant role in the nation's counterterrorism capability. The FDA fulfills this responsibility by ensuring the security of the food supply and by fostering the development of medical products to respond to deliberate and naturally emerging public health threats.

For information regarding the FDA’s regulatory responsibilities, please see the video “What Does FDA Regulate?” at the following internet address:

https://www.fda.gov/about-fda/what-we-do/what-does-fda-regulate

 

2. In terms of the mission and responsibilities of the FDA, is there a distinction between efficiency and effectiveness? If so, what is that difference?

In the context of the mission and responsibilities of the FDA, just as in any other organization, efficiency relates to performing work using the least amount of resources, while effectiveness refers to the achievement of desired work outcomes. An organization can be efficient without being effective; it can also be effective without being efficient.

Although the FDA’s delegation of food safety inspections to the states may be more efficient for the FDA itself, specifically in terms of using less FDA (federal) resources, one must inquire whether doing so would increase the effectiveness of the FDA in fulfilling its ultimate responsibility for the safety of much of the U.S. food supply. Simply saying or hoping that states do a “better job” in conducting food safety inspections does not make it so. Such a delegation could essentially undercut the essential mission of the FDA.

 

3. In your reasoned opinion, are states in a better position to address food and drug safety issues than the FDA? Explain your response, including the basis for your reasoning.

This is an opinion question, so student responses may vary.

Your author is not convinced that states are necessarily in a better position to address food and drug safety issues than the FDA. Many states may not be in a financial position to accept such responsibility. As a nation, do “we the people” really want food and drug safety to be a “roll of the dice,” with outcomes dependent on the state in which one resides? Food and drug safety is a universal issue, and therefore, at least in your author’s opinion, better centralized within the auspices of the FDA, with the achievement of food and drug safety outcomes resting with the federal government.