Chemistry Reference
In-Depth Information
For successful drugs, there is a financial reward. Global sales are about
$840 billion annually with the top ten products averaging $7.5 billion annu-
ally [10].
10.2 REGULATION
The regulation of pharmaceuticals by the United States government can
trace its roots back to 1906 when President Theodore Roosevelt signed the
Food and Drug Act, also known as the Wiley Act [11]. This act dealt mainly
with misbranding. Remember that this was the era of snake-oil salesmen and
magical elixirs. The Food, Drug and Insecticide organization, later to be the
Food and Drug Administration (FDA) was formed in 1927, but the laws were
weak.
In 1937, a chemist and pharmacist at the S.E. Massengill Co. formulated
a liquid version of the antibiotic sulfanilamide by using diethylene glycol
instead of the more commonly used ethanol. He did this without testing the
diethylene glycol for safety [12]. Over one hundred people died, many of them
children. Tragically, history repeated itself in 2006 in China when at least five
people died from kidney failure after being injected with a gall bladder drug
that used diethylene glycol [13] and again in 2007 in Panama when more than
300 people died after taking cough medicine manufactured with diethylene
glycol that was believed to be glycerin. The diethylene glycol was manufac-
tured in China and believed to have been relabeled as glycerin by a middleman
in Spain [14]. The Massengill tragedy was perhaps the worst, but not the only
tragedy of the time due to a lack of regulation. About the same time, a man
picked up horsetail weed from a railroad track, added herbs and water and
sold it as Banbar, a cure for diabetes [15]. People stopped taking their insulin
and died. The outrage of these and other tragedies led to a public outcry and
the passage of the Food, Drug and Cosmetic Act of 1938 which mandated a
premarket review of the safety of all new drugs [16].
In the late 1950s, thalidomide began to be used in Western Europe
for insomnia and to alleviate nausea associated with pregnancy. In 1960,
Richardson-Merrell Inc. submitted a new drug application (NDA) to market
thalidomide in the U.S. The FDA did not approve the application because
the reviewing medical officer, Frances Kelsey, found the proof of safety to be
lacking [17]. Later thousands of babies whose mothers had taken thalidomide
were born in Europe with horrible deformities. The FDA had prevented
a similar widespread tragedy in the U.S. In response to the thalidomide
disaster, the U.S. passed the Kefauver - Harris Amendments of 1962, which
strengthened the rules for drug safety and required manufacturers to prove
their drugs' effectiveness.
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