FDA Vision and Mission

 Printing File

Authors

A presentation by Dr. Bill MARTIN[1] , summarized by Charlotte MANTON.

Key Words

FDA Vision; FDA Mission

Abstract

The FDA is responsible for protecting and promoting the public health across all US territo­ries. This Agency regulates the food, drug, cosmetics, and tobacco industries in the United Sates. The FDA is divided in offices and centers that monitor a particular regulated geo­graphical area. The FDA has established several foreign offices worldwide – from Chile to China.

Summary

Largely driven by the efforts of Har­vey Washington Wiley, chief chemist of the Bureau of Chemistry in the De­partment of Agriculture, the passage of the 1906 Pure Food and Drug Act so­lidified public sentiment and marked the official beginning of federal con­sumer protection as a public priority. The 1906 Act – which prohibited mis­branded and adulterated food and drugs in interstate commerce – charged the Bureau of Chemistry with carrying out its duties. The Bureau eventually evolved into the FDA, un­dergoing several organizational changes along the way.

The 1906 Act was a massive step for­wards in food and drug safety, but came woefully short of the public health needs. It took the Sulfanilamide Elixir disaster of 1937 – which resulted in over 100 deaths – to prompt the passage of the 1938 Food Drug and Cosmetic Act. The Act tightened con­trols over drugs and food, including new consumer protection against un­lawful cosmetics and medical devices, and enhanced the government’s ability to enforce the law. It took yet another disaster for the next substan­tive round of legislation to pass through Congress. Thalidomide, a drug used in Europe to support sleep and treat nausea in pregnant women, resulted in severe deformities of thou­sands of children on the continent. The Thalidomide Disaster – prevented in the United States by the fastidious efforts of Dr. Frances Kelley – inspired the Kefauver-Harris Amendments in 1962 and strengthened the FDA’s re­solve on promoting both drug efficacy and safety.

During the 1970s, injuries, deaths, and other adverse events caused by medi­cal devices prompted the Medical De­vice Amendments of 1976. These amendments created three designated classes for medical devices (I, II, III) based on the degree of risk and control required to ensure safety and efficacy. Almost forty years passed before the next significant food safety laws were passed. Representative of the FDA’s change in strategy, the FDA Food Safety Modernization Act (FSMA 2011) shifted from a reactive to a proactive stance in aiming to pre-vent food con­tamination and adulterated/illicit product from ever traveling down the supply chain. The FSMA authorizes the FDA to require importers give prior notice before shipments arrive, as well as the power to deny entry or recall unsatisfactory food and drugs.

The FDA is responsible for protecting and promoting the public health across all US territories – from Guam to the Virgin Islands. This entire re­gion is divided into five regions – Pa­cific, Southwest, Southeast, Central, and Northeast. The modern economy has brought as many challenges as conveniences: globalization has re­sulted in astonishingly complex sup­ply chains and has complicated regu­latory agencies’ task of ensuring only safe and effective products reach the public. Scientific and technological breakthroughs benefit international commerce, but also bring new public health threats that must be addressed – ranging from counterfeit products to bioterrorism. These economic changes have spurred changes within the FDA; the realization that enforcing compliance is a more effective way to ensure quality and safety has precipi­tated organizational restructuring and increased the Agency’s focus on com­pliance and collaboration.

The “new” FDA is a complicated struc­ture. The Commissioner of Food and Drugs, Margaret Hamburg, oversees a collection of offices and centers each tasked with monitoring a particular regulated type of product or com­modity (e.g. biologics, veterinary medi­cine). Recently its responsibilities have expanded to include tobacco products. In recognizing the need to partner with foreign governments and regulatory bodies, the FDA has es­tablished several foreign offices worldwide – from Chile to China. FDA works with these organizations to en­courage the development of interna­tionally acceptable standards and quali­ty procedures and is committed to ensuring and improving global product safety and intelligence. The goal is to develop mutual recognition standards and global regulatory coali­tions in order to manage the immense task ahead of them.

Ultimately, the ability of the FDA to be successful in regulating the food, drug, cosmetics, and tobacco industries rests on the agency’s commitment to con­tinual improvement and proactive policy development. Partnerships with other agencies and foreign bodies will continue to refine this strategy, as will legislative trends focused on ensuring quality and accountability throughout the supply chain. p

[1] William B. MARTIN, Ph. D. Acting Regional Food & Drug Director, Pacific Region at U.S. Food and Drug Administration. Orange County, California.