FDA must meet the urgency of the moment and embrace needed reform

Shockwaves reverberated across the country when baby formula disappeared from supermarket and drugstore shelves, leaving Americans to wonder how the supply challenges of such a vital product — with so few viable alternatives — could be missed by FDA. No one expects FDA to be a supply chain expert, nor should it compromise safety. Further, the agency didn’t create the supply chain issues that led to initial formula shortages. But we must ask, would a modernized, restructured FDA have been in better position to handle the situation?  

If baby formula were a prescription drug, this may not have happened. On the drug side of the agency, regulatory requirements offer detailed visibility into pharmaceutical supply chains, providing FDA with information to proactively prevent product shortages. When there are problems at a pharmaceutical manufacturer, the inspection arm of the agency and the Center for Drug Evaluation and Research can easily work with the industry to locate and launch alternative production. But the food program’s disjointed structure and governance doesn’t allow as efficient coordination in similar situations related to food products, making it more difficult to prevent potential shortages when recalls of specialty products, such as infant formula, occur. 

Shortages are one potential consequence of the agency’s siloed oversight of food and cosmetics. The time to consider streamlining and modernizing the agency has long since run out. The FDA can and must make critical changes now or risk leaving more essential products short and consumers in the lurch. 

Looming largest among the FDA’s ongoing issues is the disjointed leadership that begets a breakdown in communication across the agency without a single, full-time, fully empowered, expert leader. There are two heads of food, each with varying responsibilities, driving a trickle-down effect of disorganization across the major food programs. The consequences of inaction at FDA are not hypothetical, but real issues the team at Consumer Brands hears about from the 2,000 brands it represents every day. The dominant themes that have emerged from countless conversations are: 
 

• The split and siloed food program undercuts communication and collaboration at the expense of efficiency and responsiveness. 
• Inefficient decision-making slows reviews, hinders progress and even renders innovation obsolete.  
• Inspector turnover and retirements makes it difficult to keep a well-trained, experienced FDA workforce. 

The importance of FDA’s mission cannot be overstated. The consumer packaged goods (CPG) industry wants and needs FDA to be successful, and Consumer Brands believes four key reforms will enable the agency’s success: unify under a single leader for food; place meaningful focus on the food program; move at the speed of consumers; take lessons from the pandemic and adapt them to permanent changes. 

Unify under a single food leader: The first step toward making real change at FDA requires unifying the food program under a single deputy commissioner for foods. Today, there are two heads who each report to Commissioner Robert Califf — constructing an organizational chart that is designed to, at best, ensure communication failures and, at worst, result in conflict with one another. A single head would have accountability to the commissioner and direct line authority over each of FDA’s major food program units — the Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine and the food-related components and operations of the Office of Regulatory Affairs — offering immediate efficiency and collaborative potential. 

Place meaningful focus on the food program: A recent investigative piece on FDA quipped, “There’s a long-running joke among FDA officials that the ‘F’ in FDA is silent.” And commissioners have leaned heavily on the drug expertise side, making it imperative that this appointee have relevant and appropriate food credentials to quickly implement modifications. A streamlined structure and a full-time senior leader translate into results that unite consumers, companies and policymakers: focused leadership, accountability and effective dialogue with myriad stakeholders. 

Move at the speed of consumers: Modernizing FDA is tantamount to unifying its leadership. The agency does not move at the speed of business and does not approach the speed of the consumer. The pandemic made clear FDA must evolve to meet consumers’ rapidly changing needs. This should be a business-critical priority for the agency as well, as reforms stand to position FDA as a leader and subject matter expert in facilitating innovation, furthering companies’ efforts to debut more sustainable packaging and better nutritional offerings that can be tied up for 18 months awaiting FDA review. 

Take lessons from the pandemic: During the pandemic, significant, lasting shifts in consumer behavior and hurdles faced by the consumer packaged goods industry forced a new nimbleness to manufacturing processes. Temporary regulatory changes to ensure continued production to meet demand ultimately proved just as safe and more efficient and should be considered for permanent adoption. Further, the pandemic proved regulators like FDA and industry can work harmoniously to improve the regulatory environment, like the implementation of remote assessments and allowing for labeling flexibility to give stretched supply chains a little slack and consumers more reliably stocked shelves. 

FDA can meet the urgency of the moment and act right away. The creation of a deputy commissioner for foods does not require an act of Congress or rulemaking. In fact, the position existed during the Obama administration and worked to ensure programs and oversight work at optimal levels. Further, FDA underwent an aggressive modernization of its medical products program several years ago and should look to that overhaul as a model and imperative for the food side of the house.  

The potential, and most of the pieces, are within FDA’s reach to implement significant and lasting change.  

Sarah Gallo is vice president of product policy  for the Consumer Brands Association, which represents nearly 2,000 iconic brands. From household and personal care to food and beverage products, the consumer packaged goods industry plays a vital role in powering the U.S. economy, contributing $2 trillion to U.S. GDP and supporting more than 20 million American jobs.