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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.
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Representatives from FDA and the state
of Virginia jointly inspect Chesapeake Bay oysters in
this photo from the mid-1980s. |
Next: Selected Additional
Readings
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