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.
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.