The Pure Food and Drugs Act of 1906 was the
beginning of the end for patent medicines; requir-
ing medicine labels to list the product’s ingredients
and spawning the federal oversight agency that
was to become the US Food and Drug Administra-
tion (FDA). In 1938 the Food, Drugs, and Cosmet-
ics Act extended the authority of the FDA to
regulate the safety and therapeutic effectiveness
(and labeling claims thereof) of drugs, requiring
manufacturers to prove a drug’s safety before
being allowed to market the drug. The regulations
arose from the sometimes deleterious adulteration
of drug products, brought to the forefront of pub-
lic outrage when the use of poisonous wood alco-
hol in a sulfa preparation caused the deaths of
more than 100 people. Shortly thereafter the FDA
established separate classifications for prescription
drugs and OVER-THE-COUNTER(OTC) DRUGS, prescrip-
tion drugs being those whose safe use required a
physician’s oversight and guidance and OTC drugs
being those that individuals could safely use with-
out the guidance of a doctor or pharmacist.
Drug advertising remained under the jurisdic-
tion of the Federal Trade Commission (FTC) until
the Drug Amendments of 1962, the first of several
key amendments to the Food, Drugs, and Cosmet-
ics Act. The 1962 Drug Amendments also gave the
FDA the regulatory authority to require evidence
of a drug’s safety as well as effectiveness before
granting approval for the drug. The Dietary Sup-
plements and Nutritional Labeling Act of 1994
drew back some authority from the FDA, how-
ever, reclassifying herbal and botanical products as
dietary supplements and removing from FDA reg-
ulatory oversight.
Challenges in Pharmaceutical Therapy
Drugs have transformed health care over the past
half century, relegating to insignificance many
infections and diseases that in previous genera-
tions meant lifelong disability or early death.
Drugs treat INFECTION, DIABETES, CARDIOVASCULAR DIS-
EASE(CVD), kidney disease, LIVERdisease, gastroin-
testinal disease, neurologic disorders, and cancer.
Doctors in the United States write more than 14
billion prescriptions a year for nearly 3,000 differ-
ent drugs, and another 2,000 medications are
available in over-the-counter (OTC) products that
are available without a doctor’s prescription.
Indeed, there are few health conditions for which
there are not pharmaceutical treatments.
Nonetheless, significant challenges exist. Health
experts worry that the expense of drugs puts them
out of reach for many people who need them and
that collectively people are developing habits in
regard to drug therapies that ultimately put health
at greater risk.
Drug costs and availability Pharmaceutical
manufacturers spend millions of dollars every year
to develop new drugs. Yet as many as 20 promis-
ing drug concepts may die in the laboratory for
every one that makes it clinical testing. For the
length of time a drug remains under patent after
its approval, an average of 14 years, the drug’s
manufacturer has an exclusive piece of a multi-
billion-dollar market. Though few dispute a phar-
maceutical company’s right to expect a financial
return on its investment, the high cost of drugs
still under patent makes the drugs unaffordable
for many people. Older people take the hardest
hit, caught in an intersection between increasing
health-care needs and a fixed income.
One major effort to reduce drug costs is generic
drugs, which are identical to their trade name
counterparts (innovator drugs) in terms of active
ingredients, DOSE, form, and efficacy (action in the
body). The Government Accountability Office
(GAO), the official expenditure watchdog of the
federal government, estimates that generic drugs
save Americans more than $10 million a year.
The high cost of drugs in the United States has
fueled interest in purchasing drugs from countries
in which they are not as expensive, such as
Canada and Mexico. Although US law prohibits
bringing imported drugs into the country, many
people order them from Internet and mail-order
sources nonetheless to save hundreds to thou-
sands of dollars each year.
Patient compliance and lifestyle choices Treat-
ing or preventing a health condition can be as
easy as taking a few pills a day. However, though
precise statistics are difficult to determine health
experts estimate that perhaps half of people for
whom doctors prescribe regular medications do
not take them as directed. They may miss doses,
combine drugs to consolidate dosages, take a
reduced dose to “stretch” the prescription, or take
the drug only when they feel symptoms. In some146 Drugs