Federal Regulation of Medications

Advances in analytical chemistry, microscope technology, and studies showing the impact of adultered foods and drugs on human life were the two factors for modern laws in the US against the adulteration of foods and drugs.

a. True

b. False

a. True

What act was passed in 1906 that prohibited the adulteration and misbranding of foods and drugs in interstate commerce?

a. Food, Drug, and Cosmetic Act

b. Kefauver-Harris Amendment

c. Orphan Drug Act

d. Pure Food and Drug Act

d. Pure Food and Drug Act

Why did the Pure Food and Drug Act fall short of providing the protection that Congress intended?

a. Misbranding provision in the law did not prevent false or misleading efficacy claims

b. The law allowed companies to use any ingredient as long as it was listed on the label

c. The law was limited to regulating only products that were sold across state lines

d. The law only applied to food products, not drugs or cosmetics

a. Misbranding provision in the law did not prevent false or misleading efficacy claims

The 1911 U.S. Supreme Court decision in United States v. Johnson held that the misbranding provision in the Pure Food and Drug Act did not prevent false or misleading efficacy claims, allowing the manufacturer to falsely claim that a drug was effective against cancer.

a. True

b. False

a. True

In the case of United States v. Johnson, it was ruled that the misbranding provision in the Pure Food and Drug Act prevented false statements to all of the following about a drug except?

a. Strength

b. Efficacy

c. Purity

d. Quality

b. Efficacy

How did some manufacturers, who feared a violation of the labeling provision, work their way around the Pure Drug and Food Act?

a. By using alternative names for ingredients to obscure their true nature

b. By exporting their products to avoid U.S. jurisdiction

c. By simply omitting information from the label

d. By selling products exclusively within state lines to avoid federal regulation

c. By simply omitting information from the label

The Pure Food and Drug Act did require the label to list ingredients, including directions for use, or provide warnings.

a. True

b. False

b. False - The Pure Food and Drug Act did NOT require the label to list ingredients, including directions for use, or provide warnings.

The Pure Food and Drug Act did regulate cosmetics or devices.

a. True

b. False

b. False - The Pure Food and Drug Act FAILED to regulate cosmetics or devices.

In what year did the Pure Food and Drug Act was amended to prohibit false and fraudulent efficacy claims?

a. 1912

b. 1913

c. 1914

d. 1915

a. 1912

Why was the Pure Food and Drug Act difficult to enforce after it was amended in 1912?

a. The act no longer applied to products sold within individual states

b. The government was required to prove fraudulent intent on the manufacturers

c. The amended act still had too many exceptions and loopholes

d. The public lost interest in the enforcement of the act

b. The government was required to prove fraudulent intent on the manufacturers

In many cases, violators of the Pure Drug and Food Act escaped enforcement by pleading ignorance.

a. True

b. False

a. True

What act was passed in 1938 which forms the nucleus of today's law?

a. Durham-Humphrey Amendment

b. Color Additive Amendment

c. Food, Drug, and Cosmetic Act

d. Nutrition Labeling and Education Act

c. Food, Drug, and Cosmetic Act

The FDCA of 1938 exempted drugs marketed before 1938 from the requirements of a label must contain adequate directions for use and warnings including habit-forming properties of certain drugs.

a. True

b. False

a. True

Which statement is true about the FDCA of 1938?

a. It was only applied to products manufactured outside the United States

b. It was primarily focused on regulating agricultural practices rather than consumer products

c. It did not include any provisions for inspecting manufacturing facilities

d. No new drug could be marketed until proven safe for use under the conditions and approved by the FDA

d. No new drug could be marketed until proven safe for use under the conditions and approved by the FDA

The FDCA of 1938 also expanded the definition of misbranding and adulteration.

a. True

b. False

a. True

This amendment was enacted in 1951 for drugs to meet the "adequate directions for use" requirements.

a. Durham-Humphrey Amendment

b. Kefauver-Harris Amendment

c. Prescription Drug Marketing Act

d. Food and Drug Administration Modernization Act

a. Durham-Humphrey Amendment

What is another name for the Durham-Humphrey Amendment?

a. Orphan Drug Act

b. Food, Drug, and Cosmetic Act

c. Prescription Drug Amendment

d. Kefauver-Harris Amendment

c. Prescription Drug Amendment

What two classes of drugs did the Durham-Humphrey Amendment establish?

a. Generic and Brand Name

b. Prescription and OTC

c. Controlled and Non-Controlled

d. Schedule I and Schedule II

b. Prescription and OTC

According to the Durham-Humphrey Amendment, labels of prescription drugs still need to contain "adequate directions for use" even if they contain the legend, "Caution: Federal law prohibits dispensing without prescription."

a. True

b. False

b. False - According to the Durham-Humphrey Amendment, labels of prescription drugs DO NOT need to contain "adequate directions for use" SO LONG they contain the legend, "Caution: Federal law prohibits dispensing without prescription."

The Kefauver-Harris Amendment authorized oral prescriptions and refills of prescription drugs.

a. True

b. False

b. False - The Durham-HUmphrey Amendment authorized oral prescriptions and refills of prescription drugs.

This amendment was passed in 1958 and required that components added to food products receive premarket approval for safety.

a. Color Additive Amendment

b. Medical Device Amendment

c. Pure Food and Drug Acr

d. Food Additives Amendment

d. Food Additives Amendment

What is a Delaney Clause?

a. Prohibits the approval of any food additive that might cause cancer

b. A regulation for drug patent extensions

c. A provision for drug importation

d. A rule for prescription labeling

a. Prohibits the approval of any food additive that might cause cancer

The Food Additives Amendment and the Color Additive Amendment both contain a Delaney Clause.

a. True

b. False

a. True

What did the 1960 amendment to the FDCA require manufacturers to do?

a. Establish the effectiveness of color additives

b. Establish the safety of color additives in foods, drugs, and cosmetics

c. Establish the cost-effectiveness of color additives

d. Establish the environmental impact of color additives

b. Establish the safety of color additives in foods, drugs, and cosmetics

What authority does the FDA have under the Color Additive Amendments?

A) Approve a color for one use but not for others (e.g., external use only)

B) Ban all color additives in foods, drugs, and cosmetics

C) Require color additives to be tested by a third-party

D) Regulate the pricing of color additives

A) Approve a color for one use but not for others (e.g., external use only)

What popular sedative in the 1950s that was being marketed in Europe caused phocomelia (seal limbs) in thousands of infants?

a. Valium

b. Diazepam

c. Thalidomide

d. Barbiturates

c. Thalidomide

Why was phocomelia so low in the United States compared to Europe in the 1950s?

a. The climate in the United States reduced the risk of phocomelia

b. The United States had stricter birth control measures

c. Thalidomide was more widely available in Europe

d. The FDA did not approve thalidomide for use in the United States

d. The FDA did not approve thalidomide for use in the United States

Because of the worldwide disaster caused by thalidomide, what was the name of the amendment that Congress enacted to the FDCA in 1962?

a. Medical Device Amendment

b. Kefauver-Harris Amendment

c. Prescription Drug Marketing Act

d. Orphan Drug Act

b. Kefauver-Harris Amendment

What was the Kefauver-Harris Amendment of 1962 also called?

a. Prescription Drug Amendment

b. Drug Quality and Security Act

c. Drug Efficacy Amendment

d. Controlled Substances Amendment

c. Drug Efficacy Amendment

Why was the Kefauver-Harris Amendment also called the Drug Efficacy Amendment?

a. It required drugs to be free of harmful side effects

b. It mandated that drugs must be proven effective before they can be marketed

c. It allowed generic drugs to enter the market

d. It required drugs to be labeled with their chemical formula

b. It mandated that drugs must be proven effective before they can be marketed

Along with ensuring a drug is effective, the Kefauver-Harris Amendment does all of the following except what?

a. Transferred jurisdiction of prescription drug advertising from the Federal Trade Commission (FTC) to the FDA.

b. Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions.

c. Established the Good Manufacturing Practices (GMP) requirements.

d. Required drug manufacturers to demonstrate bioequivalence for generic drugs before approval.

d. Required drug manufacturers to demonstrate bioequivalence for generic drugs before approval.

Under the 1938 Act, the FDA had authority to review medical devices for safety and efficacy before marketing.

a. True

b. False

b. False - Under the 1938 Act, the FDA had NO authority to review medical devices for safety and efficacy before marketing.

The Medical Device Amendments of 1976 required all the following except what?

a. Premarket approval

b. Classification of devices according to their function

c. Conformance with GMP regulations

d. Establishment of performance standards

e. Adherence to record ad reporting requirements

f. All of the above

f. All of the above