Changing Leadership Won’t Affect FDA’s Role in Public Health, Awareness, and Prevention

The U.S. Food and Drug Administration (FDA) always faces big challenges because of where it sits at the intersection of so many critical concerns: by virtue of the fact that people’s lives—quite literally—depend on what we do. Patient and consumer protection are at the heart of what we do. And I believe deeply in that fundamental mission of this agency.

What Does FDA Do?

Established by the U.S. Congress in 1906 through the Food and Drugs Act (https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/default.htm), FDA has since evolved into an ever-
expanding division of the Department of Health and Human Services to embody a broad portfolio. Some of the areas under the FDA’s jurisdiction include:

• The Food Safety Modernization Act (https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm), which has changed the food safety system from responding to illness to preventing it 
• Updates relating to cancer treatment options (https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm632142.htm), such as robotically assisted surgical devices for use in mastectomy, which is not currently approved
• Dietary supplements (https://www.fda.gov/Cosmetics/default.htm), nutritional ingredients, and pet foods

Although those are diverse areas for one federal agency to handle, FDA’s mission is to protect the public’s health (https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm) by supervising oversight in the areas of food, cosmetics, and tobacco. Working with other federal departments such as the U.S. Department of Agriculture and National Institutes of Health, FDA coordinates oversight procedures to ensure that public health safety measures are enforced, protecting the American food chain and personal hygiene products. 

FDA also speeds innovation of products: through the rigorous oversight, it has many measures in place to guard against unsafe goods reaching American consumers. The agency employs research scientists, physicians, nutritionists, statisticians, chemists, lawyers, and even oncology nurses who strive to maintain an extremely high level of operation to protect the public’s health and safety (https://www.fda.gov/AboutFDA/WorkingatFDA/default.htm).

The agency also has jurisdiction over the safety and efficacy of vaccines and their protocols—from measles and diphtheria to hepatitis A and human papillomavirus. Because of its oversight, incidence of certain diseases in the United States are at historical lows or even eliminated completely. Through updates and awareness campaigns, and with the help of  healthcare providers likes nurses, FDA protects the public’s school children (https://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Consumers/ucm345587.htm) and families from what were once devasting epidemics.

Changing Leadership’s Impact on Health Policy

As often happens in the appointed circles of high-level federal government positions, FDA Commissioner Scott Gottlieb, MD, announced his intention to step down as the agency’s head by the summer, causing some concern in the advocacy community. Gottlieb previously served in other FDA positions and returned to the agency in May 2017 (https://www.fda.gov/AboutFDA/CentersOffices/ucm557569.htm), taking a rather public role as the chief advocate for a number of public health initiatives. 

Gottlieb was a rare accessible agency lead, interested in promoting FDA and speaking with patient advocates, healthcare providers, and the general public. Under his stewardship, FDA took the lead on dramatically restricting tobacco products and the industry’s efforts to expand marketing and distribution to minors. For example, as electronic cigarettes, newer vaping mechanisms, and candy-flavored cartridges became more easily available and seemingly targeted to underage users, Gottlieb strengthened FDA’s oversight regulation (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632544.htm) to hinder access to tobacco.

On March 12, 2019, Health and Human Services Secretary Alex Azar named Norman E. (Ned) Sharpless, MD, director of the National Cancer Institute, as acting FDA commissioner. Sharpless will guide the agency and infuse the bureaucracy with sense of purpose. We don’t yet know his approach to the priorities FDA will move forward, how enforcement will be promoted, or where FDA will focus public health efforts under his direction. But what will continue is FDA’s 115-year history of trust and strength it has with the American people as a guardian of the public’s health.