FDA Commissioner Says ‘We’re Failing’ People With Type 2 Diabetes

Despite the U.S. being at the forefront of cutting-edge medical innovations, chronic disease in the country is getting worse, said FDA head Dr. Robert Califf. In particular, he singled out the growing epidemic of type 2 diabetes as a public health failure.

“These advantages unfortunately are not resulting in superior health outcomes for most individuals in the U.S.,” Califf said this week in his keynote speech at the 2024 American Diabetes Association (ADA) conference. “In fact, U.S. health outcomes are currently deteriorating.”

Nearly 40% of Americans (roughly 129 million people) have at least one chronic condition, according to the Centers for Disease Control and Prevention (CDC) – the main ones being cancer, diabetes, heart disease, and obesity. 

Diabetes is especially challenging, Califf said. Not only does the disease put a significant emotional and physical burden on people living with the condition, but the economic toll is significant, costing the U.S. healthcare system more than $412 billion each year. 

Though incredible advancements have been made in diabetes technology and treatments, the prevalence of type 2 diabetes unfortunately continues to rise at an alarming rate.

“For the larger epidemic of type 2 diabetes, we’re failing right now,” Califf said. “I don't say that lightly.”

Barriers to progress: what isn’t working?

With more and more continuous glucose monitors (CGM) and automated insulin delivery systems on the market, plus the advent of revolutionary drugs for diabetes management like Mounjaro (tirzepatide) and Ozempic (semaglutide), why aren’t health outcomes for people with diabetes improving?

A huge problem, Califf said, is access. While most health insurance plans cover medical devices and medications for diabetes, without insurance, costs add up quickly. Ozempic, for example, costs nearly $1,000 per month without insurance. Studies have found that regardless of insurance status, roughly 26% of Americans skipped or delayed treatment due to cost. 

“They say money can’t make you happy but not having enough money to pay for your medicines is definitely a factor in the outcomes of chronic disease and the incidence of diabetes in particular,” said Califf.

Even with insurance, the high demand for GLP-1 receptor agonists like Ozempic (which many people without diabetes seek out for weight loss) has led to shortages of such medications, leaving drug manufacturers and the people who need them scrambling. 

Other major issues Califf mentioned as barriers to diabetes care are race and geography. Structural racism, which unfortunately continues to be a pervasive issue in the U.S. healthcare system, has been shown to have an impact on diabetes health outcomes; not only are ethnic minorities more likely to develop diabetes, but they also have higher rates of complications and death as a result of diabetes.

Similar issues exist for people living in rural communities. Those living outside of urban areas face a higher burden of type 2 diabetes and access to adequate care, even with the explosion of telehealth services following the COVID-19 pandemic. 

What can we do to change things?

While the data is disheartening, the good news is there are things regulators, community organizations, healthcare providers, and people with diabetes can do to help turn the tide. 

Lifestyle changes like getting exercise and eating a nutritious diet can make a huge difference in diabetes management and those at risk for developing diabetes. Califf emphasized unhealthy foods as a major contributor to the development of diabetes and obesity (research finds the U.S. to have the highest intake of ultra-processed foods worldwide).

“If we look at the basics, 63% of Americans are exceeding the limit for added sugars and 77% exceed the limit for saturated fat,” he said. “This is not a very good track record, despite all the effort and knowledge we have.”

It may feel impossible to avoid all the processed foods sold in fast food restaurants and grocery stores, but Califf said there are steps people can take to get the nutrients they need – and avoid ingredients detrimental to health. 

Reading nutritional labels is a great example. If an item is packed with added sugar, saturated fat, or has a cryptic ingredient list a mile long, then avoid it. Califf said a future goal of the FDA is to move nutrition labels to the front of packages to make ingredients easier to read.

Of course, sticking to a diabetes medication regimen is critical to successful self-management. Despite all the wonderful new drugs approved for type 2 diabetes to help with glucose control, weight management, and reduced risk for complications like heart and kidney disease, Califf said these treatments are vastly underused in the type 2 community.

Though the rates of type 1 diabetes are also increasing worldwide, Califf expressed his excitement about emerging treatments for this population, including stem cell therapies that new data indicates could be a potential “cure” for type 1 diabetes.

“There's an exception for type 1 diabetes, which is on the verge of major breakthroughs in terms of biological therapies that can make an enormous difference for this special population of people with diabetes,” Califf said.

For those with type 2 diabetes, which comprises nearly 95% of all people with diabetes, the story is a little starker with its own challenges, but he said he’s no less optimistic about the possible future of effective therapy. 

“For type 2 I’m also enthusiastic,” Califf added. “But it’s a whole different game in how we get solutions to the right people at the right time.”

Learn more about diabetes treatments and management here:

• Here’s What the Future of Diabetes Care Might Look Like
• Rybelsus Now First Line Therapy for Type 2 Diabetes
• The Biggest Myth About Starting Type 2 Diabetes Drugs