PS268 – Chapter3: Drug Products and Their Regulations
The Beginnings: Reformism
The trend toward reform was given direction and energy by the public
discussion of several drug-related problems, and those first federal drug laws
reflected the specific problems that fueled their passage. (Opium was first)
Morphine: Narcotic – primary active chemical in opium. Heroin is made from.
Patent Medicines: Medicines sold directly to the public under various
trademark names, associated with the period before 1906. (Peddlers)
Opium & Chinese: US brought over Chinese workers who smoked opium – it
ended up spreading amongst the general population until laws were passed.
Cocaine: Became available in the mid 1800s and was used in medicine, tonic,
etc., became popular to sniff in lower class areas (Stimulant from coca plant)
1906 Pure Food & Drugs Act: President Roosevelt recommended in 1905 that
a law be enacted to regulate interstate commerce in misbranded and
adulterated foods, drinks and drugs. This act prohibited interstate
commerce in adulterated or misbranded foods and drugs bringing the federal
government full force into the drug marketplace.
Harrison Act of 1914: An act to provide for registration of with collectors of
internal revenue, and to impose a special tax upon all persons who produce,
import, manufacture, dispense, etc. opium or coca leaves for other purposes.
Regulation of Pharmaceuticals
Purity: FDA tests products and pursues any that are adulterated, or missed
ingredients, as well as the “therapeutic” claims.
Safety: In 1938, before a new drug could be marketed, its manufacturer must
test it for toxicity – must submit a “new drug application” (NDA) to the FDA.
Effectiveness: Every new drug be demonstrated to be effective for the illness
mentioned on the label – FDA reviewed thousands and remove ineffective.
New Drug Marketing: Companies must demonstrate through extensive
testing that the new drug they want to sel