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industry
History
Mid-1800s – 1945: From
botanicals to the first synthetic
drugs
The modern pharmaceutical industry
traces its roots to two sources. The first of
these were local apothecaries that
expanded from their traditional role
distributing botanical drugs such as
morphine and quinine to wholesale
manufacture in the mid 1800s. Rational
drug discovery from plants started
particularly with the isolation of morphine,
analgesic and sleep-inducing agent from
opium, by the German apothecary
assistant Friedrich Sertürner, who named
the compound after the Greek god of
dreams, Morpheus. Multinational
corporations including Merck, Hoffman-La
Roche, Burroughs-Wellcome (now part of
Glaxo Smith Kline), Abbott Laboratories, Eli
Lilly and Upjohn (now part of Pfizer) began
as local apothecary shops in the mid-
1800s. By the late 1880s, German dye
manufacturers had perfected the
purification of individual organic
compounds from coal tar and other
mineral sources and had also established
rudimentary methods in organic chemical
synthesis.[2] The development of synthetic
chemical methods allowed scientists to
systematically vary the structure of
chemical substances, and growth in the
emerging science of pharmacology
expanded their ability to evaluate the
biological effects of these structural
changes.
Oral Contraceptives
1970–1980s
Statins
Controversies
Product approval
In the United States, new pharmaceutical
products must be approved by the Food
and Drug Administration (FDA) as being
both safe and effective. This process
generally involves submission of an
Investigational New Drug filing with
sufficient pre-clinical data to support
proceeding with human trials. Following
IND approval, three phases of
progressively larger human clinical trials
may be conducted. Phase I generally
studies toxicity using healthy volunteers.
Phase II can include pharmacokinetics and
dosing in patients, and Phase III is a very
large study of efficacy in the intended
patient population. Following the
successful completion of phase III testing,
a New Drug Application is submitted to the
FDA. The FDA review the data and if the
product is seen as having a positive
benefit-risk assessment, approval to
market the product in the US is granted.[87]
Orphan drugs
Global sales
In 2011, global spending on prescription
drugs topped $954 billion, even as growth
slowed somewhat in Europe and North
America. The United States accounts for
more than a third of the global
pharmaceutical market, with $340 billion
in annual sales followed by the EU and
Japan.[90] Emerging markets such as
China, Russia, South Korea and Mexico
outpaced that market, growing a huge 81
percent.[91][92]
Prescriptions
Marketing
Advertising is common in healthcare
journals as well as through more
mainstream media routes. In some
countries, notably the US, they are allowed
to advertise directly to the general public.
Pharmaceutical companies generally
employ sales people (often called 'drug
reps' or, an older term, 'detail men') to
market directly and personally to
physicians and other healthcare providers.
In some countries, notably the US,
pharmaceutical companies also employ
lobbyists to influence politicians.
Marketing of prescription drugs in the US
is regulated by the federal Prescription
Drug Marketing Act of 1987.
To healthcare professionals
Regulatory issues
Pharmaceutical fraud
Laws
alleged
Company Settlement Violation(s) Year Product(s) violate
(if
applicab
False
Off-label Bextra/Geodon/
Pfizer[131] $2.3 billion 2009 Claims
promotion/kickbacks Zyvox/Lyrica
Act/FDC
False
Abbott
$1.5 billion Off-label promotion 2012 Depakote Claims
Laboratories[132]
Act/FDC
False
Eli Lilly[133] $1.4 billion Off-label promotion 2009 Zyprexa Claims
Act/FDC
Developing world
Patents
Patents have been criticized in the
developing world, as they are thought to
reduce access to existing medicines.[134]
Reconciling patents and universal access
to medicine would require an efficient
international policy of price discrimination.
Moreover, under the TRIPS agreement of
the World Trade Organization, countries
must allow pharmaceutical products to be
patented. In 2001, the WTO adopted the
Doha Declaration, which indicates that the
TRIPS agreement should be read with the
goals of public health in mind, and allows
some methods for circumventing
pharmaceutical monopolies: via
compulsory licensing or parallel imports,
even before patent expiration.[135]
Charitable programs
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Retrieved from
"https://en.wikipedia.org/w/index.php?
title=Pharmaceutical_industry&oldid=814861543"