By Joseph X. Phillips

The US Food and Drug Administration (FDA) recently published an article entitled “FDA’s Sentinel of Public Health: Field Staff Safeguards High Standards.” The article gave a concise insight into the makeup of the Field Staff and the scope of its work in protecting the public health.

Having worked in the FDA’s Field Staff in my previous career, I thought it would be interesting to share some of this information with our Members. We often don’t realize that about 25% of every dollar spent in the United States is spent on a product regulated by the FDA. Yet the FDA is one of the smaller Agencies within the Department of Health and Human Services.

I have abstracted much of this material from the FDA’s article, published in 2007.

The Agency has a mission that requires them to protect the health of all Americans. In carrying out its mission the Agency must keep in touch with consumers and firms dealing with regulated products all over the United States. The FDA regulates almost 124,000 business establishments that annually produce, warehouse, import, and transport $1 trillion worth of consumer goods. This is a most challenging task, given the size of the Agency.

About one third of the FDA’s total personnel work in the Field Staff. This Staff is directed by the Office of Regulatory Affairs (ORA). The Field Staff is stationed in more than 160 offices, resident posts, and laboratories from coast to coast and in Puerto Rico.

FDA’s Field Staff is a highly trained group. They provide the eyes, ears, and the long arm of the Agency that ensures implementation of the FDA’s high public health standards.

Some of the major activities of the ORA specialists are:

• Consumer Safety Officers (CSOs), also known as Investigators, and Consumer Safety Inspectors (CSIs) conduct about 22,000 domestic and foreign inspections a year to ensure that regulated products destined for the US market meet the Agency’s standards. The Agency inspects plants before the FDA approves a product, to make sure the firm has the capability and capacity for high quality production. They also inspect the facilities periodically after approvals, to be sure the firm follows appropriate manufacturing processes. The CSOs also monitor clinical trials that are conducted before the products are submitted to FDA for approval.
• Scientists in ORA’s 13 laboratories analyze more than 41,000 product samples each year to check adherence to FDA standards. The analyzed products include samples of the 9.3 million import shipments that have to be overseen by the FDA in the ports of entry. Imported products that do not meet FDA standards are not allowed to enter the US market.
• Public affairs specialists conduct outreach to consumer groups, health care professionals, and state health authorities to explain FDA policies and encourage compliance. In addition to briefing interested groups and responding to press inquiries, these specialists work with the rest of the field staff to respond to health emergencies.
• In the wake of the Sept. 11, 2001 terrorist attacks, the FDA‘s Field Staff was given more resources. The FDA hired an additional 655 new ORA employees, 600 of whom strengthen food safety, 35 enhance safety of animal drugs and feed, and 20 are part of the drug, biologic, and device programs. About 420 of the new hires and other employees are stationed at border locations or are working specifically on imports.

For more information, please call ORA at 301-827-3101 or visit the FDA Web site at www.fda.gov/ora.

About the Author
Joseph X. Phillips joined ISPE in 2003 as Regulatory Affairs Advisor and was appointed to the US Food and Drug Administration (FDA) as a special government employee on the Pharmaceutical Science Advisory Committee that is involved in the agency’s new “Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century” initiative. Previously, Phillips was Vice President, Pharmaceutical Services for Quintiles Consulting following a 44-year career with the FDA. At the FDA he served as Deputy Regional Director of the Agency’s Central Region. He was heavily involved in training of FDA Investigators and in planning and managing pharmaceutical programs including the Pre-Approval Inspection program and the SUPAC (Scale-Up and Post Approval Changes) for field operations. Phillips was a principal negotiator for the US/EU Mutual Recognition Agreement and was the FDA Lead to the International Conference on Harmonization (ICH) Expert Working Group for GMP Guidance for Active Pharmaceutical Ingredients (ICH Q7A Guidance)