Biomedical Engineering Reference
In-Depth Information
manufacturers. (Physicians, however, might ac-
knowledge the fact that using medical devices for
radically different purposes could make them
vulnerable to malpractice litigation.)
There are a few other, more minor misconceptions
about what the FDA does, which should be
mentioned here. Most importantly, the FDA does not
typically perform its own testing (clinical, animal, or
bench testing) on devices, but rather it is the manu-
facturers' responsibility to conduct all of the neces-
sary testing and report the results to the agency for
review. The FDA also does not preapprove promo-
tional materials for marketing of devices, although it
can take corrective actions against companies whose
promotional materials are misleading.
medical symptoms. These “Poison Squad” experi-
ments helped to focus the public's attention on the
issue of food safety, and eventually contributed to the
passage of the first federal law regulating food and
drugs, the 1906 Pure Food and Drugs Act, signed by
President Teddy Roosevelt. It is important to note
that subjects
were
informed of what they were doing,
and no one ever died or was seriously injured. Dr
Wiley himself resigned 6 years later to take over the
laboratories at
Good Housekeeping
magazine, where
he continued working to inform consumers about the
quality of their purchases by creating the famous
“Good Housekeeping Seal of Approval.”
Public attention was also focused on food safety
during this time period for a slightly different reason
besides Harvey Wiley's work. Upton Sinclair's
The
Jungle
also contributed to the public outcry that
motivated the 1906 Meat Inspection Act that was
passed on the same day as the Pure Food and Drugs
Act. This muckraking novel describes the chal-
lenging life of an immigrant worker, Jurgis Rudkus,
and the topic became famous for exposing horrors of
the meat-packing industry such as industrial acci-
dents that led to workers being incorporated into
meat products. Upton Sinclair himself was quoted as
saying that he had hoped his topic would encourage
higher wages and improved living conditions for
workers, but instead America received meat-packing
regulations: “I aimed at the public's heart, and by
accident I hit it in the stomach”
[3]
.
The Pure Food and Drugs Act of 1906 did not
immediately create the FDA (the new law was still
enforced by the Bureau of Chemistry), and it did not
yet address medical devices. It did, however, prohibit
the manufacture, sale, or transportation of adulter-
ated food products and poisonous drugs. Prior to
1906, regulation of food and drugs occurred at the
state level, and there was often wide variation in the
laws from state to state. The 1906 Act established
labeling requirements such that all food and drug
products were required to bear labels that could not
contain false statements about the contents, and if
the manufacturer chose to include the product
ingredients, weight, or volume, these details had to
be accurate. Because manufacturers were not
required to list any of these things, however, the
regulatory framework left significant room for
misleading product names (such as “Peanut Spread”
as a peanut butter substitute, or “Maple Flavored
Syrup” that was mostly corn syrup) and other lies of
omission.
17.4 Brief History of the FDA
Figure 17.1
shows a brief time line of important
events in the history of the FDA. Since its very
beginnings, the FDA has had a long history of
scientists with a desire to use their skills and exper-
tise to protect the health and welfare of the public.
1
The origins of the FDA, even before it existed as an
agency, can be traced to a group of chemists in the US
Department of Agriculture in 1883
[2]
. Led by Dr
Harvey Wiley, a physician and professor of chemistry
from Indiana, these scientists were interested in the
problem of detecting fraud in the food industry.
Transportation and storage of food were still a chal-
lenge in those days when ice was still the principal
means of refrigeration and milk was still unpasteur-
ized. Chemical additives and preservatives to prevent
food spoilage
d
or, more nefariously, to mask
it
d
were becoming more common, and the effects of
these chemicals on the human body were largely
unknown and untested. Fortunately, as the science of
chemical additives advanced, so did the ability of
science to detect the presence of these chemicals and
to study their effects on the body. Wiley's team, in
fact, sponsored a 5-year series of unconventional
experiments beginning in 1902, where volunteers
would eat increasing amounts of chemicals being
used as additives by the food industry (including
borax,
formalin, and sulfuric acid)
to look for
1
For a more thorough review of FDA history, the authors would
recommend Phillip J. Hilts'
Protecting America's Health
:
The FDA
,
Business
,
and One Hundred Years of Regulation
. New York: Knopf;
2003.
