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Because
drugs can produce harmful effects when manufactured or taken
improperly, most governments control drug development as well
as availability. In the United States, the FDA determines
how drugs are produced and how they are sold. Drugs that can
be sold over the counter (OTC)-that is, without a prescription
from a physician-are called proprietary drugs. They are considered
safe for unsupervised use by the general population. Drugs
that must be prescribed by physicians and dispensed by pharmacists
are known as ethical drugs. Their use is monitored closely
by medical personnel.
The FDA regulates the sale and manufacture of drugs in the
United States as outlined in applicable laws enacted over
the past century. Legal standards for composition and preparation
of drugs in the United States are found in the publication
known as the United States Pharmacopeia (USP). Drugs that
can be abused, such as the powerful narcotic heroin, are regulated
by the Drug Enforcement Administration (DEA) of the U.S. Department
of Justice to ensure that they are not prescribed or sold
illegally.
Before 1900 any individual could sell a drug and claim it
offered therapeutic benefits without medical proof. This changed
after 1906 with the passage of the Pure Food and Drug Act,
which required drug manufacturers to state the content, strength,
and purity of each drug they produced. The Pure Food and Drug
Act ended the practice of including morphine, cocaine, and
heroin in drugs without the public's knowledge. In 1914 the
U.S. legislature began to strictly regulate the trade of narcotics
with the enactment of the Harrison Narcotic Act; in 1937 the
government added marijuana to this list of controlled substances
(the Marijuana Tax Act).
The Federal Food, Drug, and Cosmetic Act was enacted in 1938
requiring that new drugs be safe for humans; however, it did
not require that manufacturers prove their drugs' effectiveness.
It would be 24 years before legislation was passed that would
require proof of the efficacy of new drugs (the Kefaver-Harris
Amendments, 1962). Enforcement of this law was entrusted to
the FDA.
Two laws enacted in the 1960s strengthened the FDA's efforts
to reduce drug abuse. The Drug Abuse Control Amendments of
1965 provided penalties for the illegal sale or possession
of stimulants, sedatives, and hallucinogens, and the Narcotic
Addict Rehabilitation Act of 1966 set up a federal program
for addicts that provided them with the option of receiving
treatment for their drug problems in place of a prison sentence.
In 1970 the Comprehensive Drug Abuse Prevention and Control
Act established rules for manufacturing and prescribing habit-forming
drugs. It stipulated that physicians can prescribe all drugs,
but a special license is required to prescribe drugs with
a high abuse potential. This license is issued by the Drug
Enforcement Administration.
The Anti-Drug Abuse Acts, signed into law in 1986 and 1988,
set up funding for the treatment of drug abuse and for the
creation of law-enforcement programs to fight the illegal
sale of drugs. These acts also detailed severe punishments
for individuals selling and possessing drugs illegally. Harsh
penalties for using anabolic steroids (hormones that promote
the storage of protein and the growth of tissue that are sometimes
abused by competitive athletes) were included in the 1988
act, along with the requirement that all alcoholic beverages
be labeled with warnings about alcohol's potentially dangerous
effect on the body. The 1988 act also established the Office
of National Drug Control Policy to develop an action plan
that would involve the public, as well as private agencies,
in eliminating the illegal sale of drugs; in helping individuals
who use drugs to stop; and in preventing nonusers from ever
starting to use drugs.
The U.S. government and its regulatory agencies continually
monitor the development and use of all drugs sold in the United
States to ensure that the American public has access only
to drugs that are safe and effective. Recently, the FDA introduced
legislation requiring warning labels on all over-the-counter
medication after research indicated that the nonaspirin pain
reliever acetaminophen can cause liver damage when taken in
high doses with large quantities of alcohol.
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