FDA History - Part V
In the late 1960s and 1970s the FDA lost some of its responsibilities but acquired many more. Shortly after the FDA became a part of the Public Health Service, the Department of Health, Education, and Welfare transferred several functions administered by other PHS agencies to the FDA, including regulation of food on planes and other interstate travel carriers, control over unnecessary radiation from consumer and professional electronic products, and pre-market licensing authority for therapeutic agents of biological origin. The latter originated under the predecessor of the National Institutes of Health in the Biologics Control Act of 1902, which followed the deaths of thirteen children from a tetanus-tainted batch of diphtheria antitoxin in St. Louis, and nine pediatric fatalities from similar circumstances in Camden, New Jersey. (At right, a scientist in FDA's Center for Biologics and Research is conducting research on the organism that causes the childhood disease pertussis.) Congress had authorized the FDA to regulate consumer products such as potential poisons, hazardous toys, and flammable fabrics in a number of laws dating back to 1927, but this function was transferred to the Consumer Product Safety Commission in 1973.
Changes in the work of the FDA have come rapidly in the past 20 years, shaped at least in part by political pressure, consumer activism, and industry involvement. Patient advocacy groups influenced a law to stimulate industry interest in developing so-called orphan drugs for rare diseases, and they played a role in the agency's development of accelerated techniques for drug approval, beginning with drugs for AIDS. Congress passed a law that simultaneously extended patent terms to account for time consumed by the drug approval process and facilitated the approval of generic human and animal drugs to offer a lower-cost alternative to brand name pharmaceuticals. Also, Congress instituted procedures for industry to reimburse the FDA for review of drugs and biologics to speed the agency's evaluations.
Other laws have mandated reporting of adverse reactions to medical devices, post-market monitoring of implants and other devices that pose a serious health risk, recall authority for the FDA over medical devices, and certification and annual inspection of mammography facilities. Among food regulatory issues in the past two decades, Congress issued a singular prohibition against the FDA's banning saccharin under the Delaney Clause on the grounds that the sweetener had been shown to cause cancer in laboratory animals; instead, saccharin would have to carry a label warning. In 1990 Congress passed the Nutrition Labeling and Education Act, which completely reformulated the way food products convey basic nutritional information. Four years later, after intense lobbying by the dietary supplement industry, Congress permitted supplements to carry substantiated statements about the role of such products in health, provided they issued a disclaimer that FDA had not evaluated the statements. Moreover, the FDA rather than industry had the burden of proving that a dietary supplement was misbranded or adulterated.
The burgeoning interest in reinventing government and regulatory reform in the 1990s very much included the FDA, with the greatest interest focusing on the agency's time spent in evaluating therapeutic and other products. These were by no means original developments, at least as far as FDA was concerned. Numerous Congressional investigations, external and internal committee reports, independent fact-finding missions, and other venues of inquiry have studied the agency's mission and needs through much of the past century: precisely what one would expect for one of the oldest consumer regulatory agencies in the government, with such a broad responsibility for the public health, sometimes covering issues that have polarized large segments of American society. Such issued included sodium benzoate, sulfur dioxide, and other food preservatives during the Wiley era; Banbar in the 1930s; aminotriazole-tainted cranberries in the 1950s; vitamins in the 1970s; and breast implants in the 1990s. But these and other high visibility cases were just a small fraction of the agency's work, arcane to most of the public, but nevertheless a key ingredient in 20th century U.S. history.
Representatives from FDA and the state of Virginia jointly inspect
Chesapeake Bay oysters in this photo from the mid-1980s.