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203
income than alternative activities open to them. Neither the
users nor the producers would be able to put their hands in any-
body else's pocket to maintain a service that did not satisfy this
condition.
FOOD AND DRUG ADMINISTRATION
By contrast with the ICC, the second major foray of the federal
government into consumer protection—the Food and Drug Act of
1906—did not arise from protests over high prices, but from con-
cern about the cleanliness of food. It was the era of the muck-
raker, of investigative journalism. Upton Sinclair had been sent
by a socialist newspaper to Chicago to investigate conditions in
the stockyards. The result was his famous novel, The Jungle,
which he wrote to create sympathy for the workers, but which
did far more to arouse indignation at the unsanitary conditions
under which meat was processed. As Sinclair said at the time, "I
aimed at the public's heart and by accident hit it in the stomach."
Long before The Jungle appeared and crystallized public senti-
ment in favor of legislation, such organizations as the Women's
Christian Temperance Union and the National Temperance So-
ciety had formed the National Pure Food and Drug Congress
(1898) to campaign for legislation to eliminate the medical
nostrums of the day—mostly heavily laced with alcohol and so
enabling spirits to be purchased and consumed in the guise of
medicine, which explains the involvement of the temperance
groups.
Here, too, special interests joined the reformers. The meat
packers "learned very early in the history of the industry that it
was not to their profit to poison their customers, especially in a
competitive market in which the consumer could go elsewhere."
They were especially concerned by restrictions on the importation
of U.S. meat imposed by European countries, using as an excuse
the allegation that the meat was diseased. They eagerly seized the
opportunity to have the government certify that the meat was
disease-free and at the same time pay for the inspection.'
Another special interest component was provided by the phar-
macists and physicians through their professional associations,
though their involvement was more complex and less single-

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FREE TO CHOOSE: A Personal Statement
mindedly economic than that of the meat packers—or of the rail-
roads in the establishment of the ICC. Their economic interest
was clear: patent medicines and nostrums, sold directly to the
consumer by traveling medicine men and in other ways, competed
with their services. Beyond this, they had a professional interest
in the kinds of drugs and medicines available and were keenly
aware of the dangers to the public from useless medicines prom-
ising miraculous cures for everything from cancer to leprosy.
Public spirit and self-interest coincided.
The 1906 act was largely limited to the inspection of foods and
the labeling of patent medicines, though, more by accident than
design, it also subjected prescription drugs to control, a power
which was not used until much later. The regulatory authority,
from which the present Food and Drug Administration developed,
was placed in the Department of Agriculture. Until the past fifteen
years or so, neither the initial agency nor the FDA had much effect
on the drug industry.
Few important new drugs were developed until sulfanilamide
appeared in mid-1937. That was followed by the Elixir Sulfa-
nilamide disaster, which occurred as a result of a chemist's efforts
to make sulfanilamide available to patients who were unable to
take capsules. The combination of the solvent he used and sulfa-
nilamide proved deadly. By the end of the tragedy "a hundred and
eight people were dead—a hundred and seven patients, who had
taken the `elixir,
'
and the chemist who had killed himself."
8
"Manufacturers themselves learned from the . . . experience the
liability losses that could be suffered from the marketing of such
drugs and instituted premarketing safety tests to avoid a repeti-
tion."
s
They also realized that government protection might be
valuable to them. The result was the Food, Drug, and Cosmetic
Act of 1938, which extended the government's control over ad-
vertising and labeling and required all new drugs to be approved
for safety by the FDA before they could be sold in interstate com-
merce. Approval had to be granted or withheld within 180 days.
A cozy symbiotic relation developed between the pharmaceu-
tical industry and the FDA until another tragedy occurred, the
thalidomide episode of 1961-62. Thalidomide had been kept off
the U.S. market by the FDA under the provisions of the 1938 act,
though limited amounts of the drug have been distributed by phy-

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205
sicians for experimental purposes. This limited distribution ended
when reports surfaced about deformed babies born to European
mothers who had taken thalidomide during pregnancy. The sub-
sequent uproar swept into law in 1962 amendments that had
developed out of Senator Kefauver's investigations of the drug
industry the prior year. The tragedy also changed radically the
thrust of the amendments. Kefauver had been concerned primarily
with charges that drugs of dubious value were being sold at unduly
high prices—the standard complaint about consumer exploitation
by monopolistic business. As enacted, the amendments dealt more
with quality than price. They "added a proof-of-efficacy require-
ment to the proof-of-safety requirement of the 1938 law, and they
removed the time constraint on the F.D.A.'s disposition of a New
Drug Application. No new drug may now be marketed unless and
until the F.D.A. determines that there is substantial evidence not
only that the drug is safe, as required under the
1938
law, but that
it is effective in its intended use."
io
The 1962 amendments coincided with the series of events that
produced an explosion in government intervention and a change
in its direction: the thalidomide tragedy, Rachel Carson's Silent
Spring, which launched the environmental movement, and the
controversy about Ralph Nader's Unsafe at Any Speed. The FDA