The U.S. Food and Drug Administration (FDA) is the agency responsible for ensuring the safety and effectiveness of human and animal drugs, the food supply, biological products, medical devices, cosmetics, radiation-emitting devices and tobacco products.

Today the agency is facing major public health challenges brought on by the demands of the 21^st century. Science and technology are changing more rapidly and more dramatically and we must also deal with an increasingly globalized world.

In a series of blogs, JE Hamilton and Associates will discuss the priorities and goals laid out by the FDA towards achieving its vision for the next five years.

The Commissioner has selected four areas to serve as strategic priorities over the next five years:

• Advance Regulatory Science and Innovation
• Strengthen the Safety and Integrity of the Global Supply Chain
• Strengthen Compliance and Enforcement Activities to Support Public Health
• Address the Unmet Public Health Needs of Special Populations

Advance Regulatory Science and Innovation

Over the next five years, the agency will create and implement a plan for expanding and modernizing the field of regulatory science. The FDA must possess a scientific capability to become engaged in mission critical fields of applied research, system biology, wireless devices, nanotechnology, imaging, robotics, regenerative medicine, and combination products.

Strengthen the Safety and Integrity of the Global Supply Chain

Some of the challenges presented by globalization are:

• Increased volume of imports
• Greater complexity of imported products
• More foreign manufacturers supply product
• Incomplete regulatory information about the product’s supply chain
• Lack of proper regulatory oversight of product safety
• Better chance for fraud
• Possible security threat
• Increased FDA workload
• Insufficient legal authority in some cases and lack of the proper enforcement tool

The growing challenges of globalization have far outstripped the nation’s budget for inspection and quality monitoring and the inability to maintain oversight. Addressing these challenges will require a shift to a focus on preventing threats or problems before they become issues. FDA will need more and better data about the product’s supply chain and better monitoring of that information during the product’s life cycle.

Strengthen Compliance and Enforcement Activities to Support Public Health

The FDA is implementing several new schemes designed to enhance its regulatory, compliance and enforcement systems. Some of those schemes involve establishing shorter time frames for industry to respond to inspectional findings, a process to prioritize follow up inspections after the issuance of a Warning Letter, a Recall, or other enforcement actions. FDA will work more closely with its regulatory and enforcement partners to share data. This increased collaborative approach will help to identify public health issues faster and enhance corrective actions.

Address the Unmet Public Health Needs of Special Populations

FDA will create a new Office of Minority Health to address challenges to reduce health disparities in the United States.

I will address these priorities as they impact the various program areas in later blogs.

Posted in FDA