FDA Marks 100 Years of Drug Manufacturing Oversight

Efforts to ensure drug purity and safety continue to evolve and to challenge industry and regulatory officials.
Aug 02, 2006
Volume 30, Issue 8

Jill Wechsler
The US Food and Drug Administration is 100 years old this year. Its origin dates to June 1906 when President Theodore Roosevelt signed the Pure Food and Drugs Act into law. The agency began as the Drug Laboratory in the Bureau of Chemistry of the US Department of Agriculture, and its main task was to test whether drug products and ingredients met standards for strength and purity. Most medicines were ineffective, and some even dangerous. The Pure Food and Drugs Act had no premarket approval requirements and gave the government little authority to remove fraudulent drugs from the market.

It took another 50 years and several health crises for Congress to require evidence of a drug's safety, quality, and efficacy. Today, FDA has some 10,000 staffers and a $2-billion annual budget but is hard pressed to keep up with expanding responsibilities. Agency leaders consider it their public-health responsibility to help speed patient access to needed therapies as well as to keep unsafe medical and food products off the market. This mandate has stimulated a host of initiatives to streamline regulatory policies and procedures. Globalization has transformed how FDA monitors regulated products; user fees have altered the agency's relationship with manufacturers; and new technologies continually transform FDA operations.

Challenges for CDER
Many of these themes will continue during FDA's next hundred years, commented Deputy Commissioner for Operations Janet Woodcock at the annual meeting of the Drug Information Association in June. FDA needs a more formal focus on bioinformatics and improvements in how it processes huge volumes of information, she pointed out. Unfortunately, the agency is plagued by inadequate funding, Woodcock said, noting a perennial "mismatch between resources and expectations."

FDA's future resources will be up for discussion during the next year as part of negotiations for renewing the drug user-fee program, added Murray Lumpkin, deputy commissioner for international and special programs. How policymakers revise that program "will define how FDA does business going into its second 100 years," he commented.

Weak authority

In its early years, the main work of the Bureau of Chemistry's Drug Laboratory, which became the Drug Division, was to examine and test samples of synthetic and natural drug ingredients and products. Some 2000 domestic and imported items were sampled in 1910. Most of the staff were chemists and pharmacologists who assessed drug manufacturing, formulation, and purity and helped develop methods to improve pharmaceutical analysis.

But, this office didn't have enough clout to stop Johnson's Mild Combination Treatment for Cancer from making false claims of effectiveness. Patients died from impure anesthetics, and improperly packaged chloroform decomposed into a dangerous substance. In the 1920s, the Bureau began collaborating with the US Pharmacopeia to study and develop reference standards for bio-assayed drugs such as digitalis.

The agency, however, did not gain any real teeth for regulating unsafe and ineffective products until a national disaster raised a public outcry. Congress approved the Food, Drug, and Cosmetic Act of 1938 after more than 100 people, including many children, died in 1937 from a poisonous ingredient in elixir sulfanilamide. To prevent more catastrophes of this sort, the new law required manufacturers to test the safety of new drugs and submit the results in new drug applications (NDAs) before marketing. It authorized inspections of drug manufacturing facilities and set requirements for product labels.

In the first year of the preapproval requirement, FDA received more than 1200 applications. Congress expanded FDA's responsibilities further in 1941 by requiring premarket testing of all batches of insulin for purity, strength, quality, and identity. And, a 1945 Penicillin Amendment established similar testing requirements for that drug.

Effective as well as safe

Throughout the 1950s, various experts and advisors developed new strategies for improving and expanding drug regulation. FDA launched an adverse drug reaction reporting system in 1955. A major reorganization in 1957 established a Bureau of Medicine and a Bureau of Biological and Physical Sciences.

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