The Case for Senate-Confirmed Leadership at the FDA

They're not.

Career bureaucrats helm several federal sub-agencies at the Food and Drug Administration (FDA) that they brand as "centers." These unaccountable entities are the Center for Biologic Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Tobacco Products (CTP), and the Center for Veterinary Medicine (CVM). These sub-agencies are nearly unchecked when it comes to controlling what we put into our bodies and what we put into our children's bodies. From baby formula and eggs to the COVID-19 vaccines, over-the-counter medication, and vapes, the FDA exerts dominion over it all with little accountability.

It's time that we demand a change to the status quo. It is not unreasonable to require the individuals who oversee this massive government agency to answer questions by our elected representatives before they push an agenda on the American people.

The CBER is the FDA's way of regulating biological products, including vaccines, blood and blood components, cellular and gene therapies, and tissue products. CBER ensures that these products — which address various conditions, from infectious diseases to cancer — are deemed safe, effective, and available to those in need. The individual overseeing CBER directs critical regulatory and research activities that advance public health by promoting innovative biologics and stringent oversight of product safety.

Given the significance of this position — and its impact on the COVID-19 pandemic — it is time for Congress to reclaim its Constitutional authority and confirm this position by the Senate. Confirmation by the United States Senate would enhance leadership accountability and public trust in biologics regulation . . . and trust is precisely what the FDA needs if it is going to fight against any future pandemics.

The CDRH is the FDA division responsible for regulating medical devices and radiological products to ensure their safety and effectiveness. These devices include many products, from simple items like bandages to complex technologies like pacemakers and MRI machines to radiation-emitting products like X-rays and laser systems.

The Director of CDRH oversees critical functions that directly impact public health and safety. This leadership role has direct control over the well-being of millions of Americans. It is currently held accountable by the Human Resources department of the FDA . . . not the American public or those elected to represent them. By making this position Senate confirmable, a new level of standards, accountability, and competence could be set and expected for whoever serves in this significant role.

The CDER oversees the regulation of over-the-counter and prescription drugs, including bio-pharmaceuticals. The mission set by the FDA is to ensure that these drugs are safe and effective for their advertised, intended, and prescribed uses. CDER's responsibilities include evaluating new drug applications, monitoring the manufacturing processes, ensuring quality control, and conducting research to establish new standards and regulations.

The individual leading the CDER plays a pivotal role in public health because they are the final arbiter to ensure that medications meet the minimum required safety and efficacy standards. Due in no small part to the COVID-19 Pandemic, there needs to be more public trust in this department and its leadership. This void of trust offers clear justification for the position to become subject to confirmation by the United States Senate to provide enhanced oversight and rebuild public trust.

The CFSAN is primarily responsible for the safety and nutritional quality of the United States' food supply, excluding meat, poultry, and certain egg products (which fall under the jurisdiction of the United States Department of Agriculture). CFSAN's daily deliverables include regulating food additives, dietary supplements, and cosmetics and developing and enforcing food safety standards.

The head of CFSAN is crucial in protecting public health and is a small part of our national security infrastructure. Their oversight of various food and cosmetics products warrants Senate confirmation. Allowing the Senate to exercise its constitutional authority to provide advice and consent will provide high accountability and increase public confidence in managing food safety and nutritional health. 

Considering recent issues surrounding egg production and baby formula, it is clear that a massive and immediate change is needed at CFSAN. It is beyond time to make this position answerable and accountable.

The CTP is responsible for implementing the Family Smoking Prevention and Tobacco Control Act, overseeing regulating the manufacturing, marketing, and distribution of tobacco products within the United States to protect public health — particularly among youth. Their area of focus includes reviewing applications for new tobacco products, enforcing advertising and promotion restrictions, and developing and implementing public health standards for tobacco products.

The Director of the CTP leads efforts to regulate the tobacco industry and has the authority and power to change the entire industry overnight. With this unchecked power, millions of Americans could encounter massive and sweeping reforms within an industry they engage with daily. This possibility demands and justifies accountability to the United States Senate as it will ensure the leadership of the CTP does not unilaterally damage or hinder an industry that carries such considerable significance to numerous economies and livelihoods of families worldwide.

The CVM ensures the safety and effectiveness of animal drugs, feeds (including pet foods), and veterinary devices. The CVM's oversight extends to products used in pets, livestock, and other animals with an enhanced focus on protecting human and animal health.

The leadership of the CVM leads critical initiatives to prevent and treat animal diseases, safeguard food from animal sources, and ensure that all veterinary products meet rigorous health and humane standards. Without the ability of the United States Senate to review, question, and ultimately confirm the leader of this sub-agency, there is a real-world chance that veterinary medicine and its effect on our nation's public health and the safety of our food supply could be co-opted by inexperienced and under-qualified individuals.

The argument for these agency heads to become confirmable by the United States Senate is compelling and rooted in the strong desire for increased accountability, transparency, and trust in an agency that plays a critical role in the health and safety of the American people.

Each center — from CBER to CVM — oversees aspects of healthcare and consumer products that touch the lives of every American and every visitor to the United States. The far-reaching impact of their decisions, particularly in times of crisis (such as the COVID-19 Pandemic), underlines the need for leaders who are not only experts in their fields but also held to high standards of public accountability and trust.

Furthermore, it would restore and bolster public confidence in the FDA's decisions and its "unwavering" commitment to the welfare of the public good. We have taken the liberty of drafting the rough foundation of this legislation. It is time for Congress to act to ensure that the leadership of the FDA is subject to the scrutiny and approval of the elected representatives of the People, reflecting the democratic principles upon which our nation was founded and operates.