White House’s Reorganization Plan Would Make For A Leaner, Better FDA

White House’s Reorganization Plan Would Make For A Leaner, Better FDA

The administration proposes changing the FDA’s name to the ‘Federal Drug Administration,’ making clear that its focus will solely be on drugs, devices, biologics, and tobacco.
Nicole Fisher
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Following a March 2017 executive order asking the Office of Management and Budget (OMB) to make government “lean, accountable and more efficient,” the White House has released a proposal it claims will do just that. The 132-page document suggests changes to both the scope and oversight of federal agencies, as well as renaming some.

While the ideas for reforming the Department of Health and Human Services (HHS), including renaming it the “Department of Health and Public Welfare,” are broad and read like rearranging some deck chairs under a new organizational chart, the new structure stands to benefit those wanting clearer boundaries for health-related regulation. For instance, the Department of Health and Public Welfare would absorb some food welfare programs currently run by the Department of Agriculture (USDA) to combine all welfare programs into one government agency.

But re-shuffling HHS duties starkly contrasts the specifics for the Food and Drug Administration (FDA), which seem clearly intended to reduce the agency’s mission. The Trump administration has proposed fundamentally transforming the mission by transferring most of the responsibility for regulating food safety to the USDA.

In doing so, the administration proposes changing the FDA’s name to the “Federal Drug Administration,” making clear that its focus will solely be on drugs, devices, biologics, and tobacco. Subsequently, a new agency within the USDA, the “Federal Food Safety Agency,” would take over review of all food safety.

The Field Has Changed, So Should the FDA

This proposal should garner a lot of support from science and health professionals. Especially with the rise of digital medicine and therapeutics, as well as the explosion in biologics and biotechnology, many see a growing need for the FDA to focus its resources more narrowly. However, all previous attempts to do something similar have failed in Congress.

This proposal, like those in previous administrations, suggests many changes that will require congressional approval. That ultimately means nobody should expect this will move quickly. Turf wars rumored to be going on between the FDA and the USDA could add conflict to this inertia. The primary overlapping areas of contention are food and nutrition, a conflict that is nothing new to either agency.

A report by the Government Accountability Office (GAO) from as far back as 2005 concluded the overlap between FDA and USDA was troubling. In fact, the 96-page report was entitled, “Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources.” It went on to document how both the “USDA and FDA conduct similar inspections at 1,451 dual jurisdiction establishments,” such as facilities that produce foods both agencies regulate.

The broad scope of FDA’s regulatory authority is not necessarily its own fault. The agency’s responsibilities continue to grow, despite close relations to those of other government agencies. Federal statutes have given responsibility for different portions of the food supply chain to different agencies. The goal is to ensure the food we consume is safe, but when the FDA and the USDA are responsible for regulating food safety, alongside the Environmental Protection Agency (EPA) and the National Marine Fisheries Service (NMFS), things can and do turn into a nightmare pretty quickly.

The Current System Is Utterly Irrational

As you can imagine, this makes life for farmers, producers, and consumers frustrating and confusing. For example, classification of fish defies all rationale. Fish fall under FDA jurisdiction. But catfish are under the oversight of the USDA, thanks to the 2008 farm bill. Because the USDA has the staff and budget to do many more quality checks, catfish get a daily inspection, while their friends shrimp and salmon are rarely visited. Then if the fish are swimming in water, which they tend to do, they also belong to the EPA and the NMSF.

Then there are eggs. Food Safety News published an example in 2010 about the highly complex process of investigating that year’s Salmonella outbreak in Iowa. Why? Because an egg in a shell belongs to the FDA, but egg products (including liquid, frozen, and dehydrated eggs) belong to the USDA.

Now take a step back. The food chickens consume is regulated by the FDA, but the facilities where the chickens lay the eggs that belong to the FDA are under USDA jurisdiction. Thus, the Salmonella egg danger is the responsibility of the FDA, but any manure near the FDA’s egg was property of the USDA. All the while, the poor farmers, grocery stores, and consumers were exposed to Salmonella.

So what does the FDA currently regulate? For food and nutrition, the FDA has authority over everything from baby food to meat to water bottles to dietary supplements. But each category depends on its overlap with other agencies.

Therefore, one hopes at least the FDA portion of the White House effort to create a leaner, more accountable, more efficient government comes to fruition. Although the move might feel like a slight to the FDA, we would all be better served with an agency solely focused on drugs, devices, biologics, and tobacco. Given the pipeline in each of those areas, there will be plenty of work to do.

Nicole Fisher is a Senior Contributor at The Federalist, the founder and CEO of HHR Strategies, a health and human​ ​rights​ ​focused advising firm. She is also a senior policy advisor on Capitol Hill and expert on health ​reform, technology​ and brain health -​ specifically as they impact vulnerable populations.
Photo FDA photo by Michael J. Ermarth

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