Lecture #3 Flashcards
Pharmacy law before 1900
Oversight on medications is slim to none:
* Little known about the contents of medications
* No requirement for efficacy
* No requirement for safety
* Only notable law is regarding the importation of drugs, passed in 1848. Required U.S. Customs inspection to prevent adulterated drugs from entering the country.
* Patent medications used widely and without federal review
What is a patent medication?
Also referred to as “nostrum”
* Heavily advertised products purported to cure numerous diseases, with no regard to ingredients within or the safety and/or effectiveness of those ingredients
* Many died from poisoning, overdose, or delay of appropriate treatment
Who was Harvey Washington Wiley?
Harvey Washington Wiley was a faculty member at Purdue University from 1874-1882. After being passed over for the presidency at Purdue because he was “too young and too jovial,” he became the Chief Chemist of the United States Department of Agriculture.
He was instrumental in bringing light to the inclusion of contaminants in food and drugs and championed proper labelling of products.
Dubbed the “Father of the Pure Food and Drugs Act,” Wiley Hall is named after him on campus.
1905: The Great American Fraud
Exposé published in 1905 by Samuel Hopkins Adams in a series of articles in Collier’s Weekly.
“Gullible America will spend this year some seventy-five millions of dollars in the purchase of patent medicines. In consideration of this sum it will swallow huge quantities of alcohol, an appalling amount of opiates and narcotics, a wide assortment of varied drugs ranging from powerful and dangerous heart depressants to insidious liver stimulants; and far in excess of all other ingredients, undiluted fraud.”
1906: The Jungle
Written by Upton Sinclair in 1906, describes working conditions in the meat industry, in an effort to advance Socialism.
* Biggest take away from the American public was the health violations and unsanitary practices in food processing.
* Sinclair is quoted, saying “I aimed for the public’s heart, and by accident I hit it in the stomach.
1906: Pure Food and Drug Act
First federal law regulating medications, it was limited to drugs moving in interstate commerce.
* Recognized the U.S. Pharmacopeia and the National Formulary as standard drug references.
* Defined “misbranding” and “adulteration” and assigned penalties to each practice.
* Established the Bureau of Chemistry in the U.S. Department of Agriculture as the responsible party for enforcement. Renamed the Food and Drug Administration (FDA) in 1930.
What is offical compendia?
This consists of three publications*:
* United States Pharmacopoeia (USP)
* National Formulary (NF)
* Homoeopathic Pharmacopoeia of the United States (HPUS)
*USP and NF merged in 1975, now just a single resource (USP-NF)
What is adulteration?
Generally, is the product inside the bottle what it is intended to be? If the answer is no, it is adulterated.
a. Product contains any poisonous or insanitary ingredients or lacks adequate controls in manufacture.
b. Strength, quality, or purity differs from the official compendium
c. Strength differs from representation if not found in official compendium
d. Product is mixed with another substance to reduce its quality or strength, or substituted altogether
j. Delayed, denied, or limited inspection, or refusal to permit entry or inspection
Adulteration of devices
e. Devices not in conformity with performance standards
f. Certain class III devices that do not have appropriate approval for
use
g. Banned devices (prosthetic hair fibers, powered gloves)
h. Manufacture, packing, storage, or instillation of a device not conforming to applicable requirements or conditions
i. Failure to comply with requirements under which a device was exempted for investigational use
What are classes of devices?
class I, II, and III
Class I devices
not used for supporting human life and/or preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury
Class II devices
moderate risk to use, require special controls to assure safety and effectiveness of devices
Class III devices
high risk to use, support or sustain human life or preventing impairment of human health, and do present a potential unreasonable risk of illness or injury
What is misbranding?
Generally, is the packaging containing the product (or which must accompany the product) what it is intended to be? If the answer is no, it is misbranded.
a. Labeling that is false or misleading.
b. Labeling that does not contain the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or count.
c. Required information is not prominently displayed or clearly stated.
e. Established name not included (and at least 1⁄2 has large as the proprietary
name)
f. Directions and required warnings not included on label
g. Not in compliance with official compendia standards for packaging
h. If the product is liable to deteriorate, unless it is packaged
appropriately and notes an expiration date
i. If the drug container is developed in a misleading way, or is an imitation of another drug
j. If use of the drug as prescribed is dangerous to health
m. If an ingredient is a color additive only, and not in compliance
labeled appropriately
n. If advertisements do not include required information
p. If packaging safety requirements are not met
y. If a risk evaluation and mitigation strategy (REMS) is required and
not appropriately addressed
cc. If a product identifier is required and not included (Rx-Only, Controlled Substance markings, etc.)
Established name vs proprietary name
established name = generic name
proprietary name = brand name
Can a drug be both adulterated and misbranded?
Yes, but only in certain circumstances:
* Generally, there must be either two separate infractions, or a course of action leading to both criteria being met. Here are two examples:
1. A product is stored outside its recommended temperature (adulterated), leading its label to fall off due to adhesive failure (misbranded)
2. An expired drug is counted put into a prescription bottle (adulterated) and then dispensed to a patient (misbranded)
Pure Food and Drug Act Limitations,
United States v. Johnson
The 1906 law was challenged in the Supreme Court in 1911, where the Supreme Court ruled that the Pure Food & Drug Act only prevented false statements on the drug’s identity, and not false or misleading efficacy claims.
* Congress tried to fix this…
1912: The Sherley Amendment
To address the Supreme Court ruling in United States v. Johnson, Congress passes an amendment in 1912 to the Pure Food and Drug Act:
* Prohibits manufacturers from intentionally misleading claims about a drugs effectiveness.
* The onus was on the government to prove intent, which made this amendment extremely difficult to enforce.
* Many medications were allowed to remain on the market for years, even those widely known to have false claims and safety risks.
1933: FDA pushes for overhaul of 1906 pure food and drug act
The FDA put together an exhibit showing many of the tricks and dangerous practices food, drug and cosmetic companies conduct
* The goal was to get Congress to support a complete overhaul of the Pure Food and Drug Act legislation.
* This exhibit went across the country and was dubbed The American Chamber of Horrors.
* Even this powerful display was not enough to push legislation through Congress, tragedy was required…
1937: elixir sulfanilamide tragedy
“The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. … It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight.“
-Mother of victim, in letter to President Franklin Delano Roosevelt
1938: Federal food, drug, and cosmetic act
Permitted FDA control over cosmetics and therapeutic devices
* Required new drugs to be shown safe before marketing
* Repealed Sherley Amendment requirement to prove intent to defraud in drug misbranding cases
* FDA provided safe tolerances be set for unavoidable poisonous substances
* Authorized factory inspections
* Included court injunctions to the FDA tool belt alongside penalties for seizure and prosecutions
* Required selected dangerous drugs to be administered under the direction of a qualified expert (beginning requirement for prescription only medications)
Definition of a drug: federal food, drug, and cosmetic act
Must meet four criteria:
A. Articles recognized in the official compendia
B. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
C. Articles (other than food) intended to affect the structure or any function of the body of man or other animals
D. Articles intended for use as a component of any articles specified in (A), (B), or (C)
1950: Alberty food products co v US
Alberty manufactured and distributed drugs that were noted to be misbranded by the FDA for failure to bear adequate directions for use. Alberty challenged this ruling.
* The court focused on the label of the medications and whether the label contained all required information.
* The court ruled that “In order for the labeling of a drug to bear” adequate directions for use“… it must, among other things, state the purposes and conditions for which the drug was intended and sufficient information to enable a layman to intelligently and safely attempt self-medication.
* Under this ruling, several medications would not bear adequate directions for use…
1951: Durham-Humphrey amendment
Written by two pharmacists, Senator Hubert H. Humphrey Jr. (later Vice President of the United States) and Representative Carl Durham.
* Addressed those medications that were not safe for use except under medical supervision, separating medications into two classes:
* Over-the-counter medications could be labeled with “adequate directions for use.”
* Legend medications had to be dispensed under the supervision of a health practitioner as a prescription drug and carry the statement “Caution: Federal law prohibits dispensing without a prescription.” So long as prescriber directions were included on the label, this satisfied the adequate directions for use statute.
* This amendment also allowed verbal transmission of prescriptions and refills for prescription drugs.
