Question

Which drug law stated that all drugs must be pure, safe, and effective?

a) Controlled Substances Act
b) Food, Drug, and Cosmetic Act
c) Prescription Drug Marketing Act
d) Kefauver-Harris Amendment

Answer 1

The Food, Drug, and Cosmetic Act ensures that all drugs must be pure, safe, and effective. It is a piece of legislation that the FDA enforces for regulating prescription drugs, overshadowing the older Pure Food and Drug Act from 1906. This act protects consumers but can also delay access to new drugs for patients.

Step-by-step explanation:

The drug law that stated all drugs must be pure, safe, and effective is the Food, Drug, and Cosmetic Act. This act, first passed in 1938, governs the U.S. Food and Drug Administration's regulation of prescription drugs, including their safety, efficacy, and manufacturing standards. The Pure Food and Drug Act of 1906 was a precursor to the Food, Drug, and Cosmetic Act, also emphasizing drug purity but not as comprehensively addressing safety and efficacy.

The winners in this regulatory system are consumers who are protected from unsafe or ineffective drugs. Losers in the system could be considered those patients who need access to new treatments quickly but face delays due to the extensive testing and regulatory approval process required to demonstrate safety and efficacy.