The Pure Food and Drug Act (PFDA) of 1906 was significant in that it gave the government the power to prohibit drug labels from claiming false therapeutic benefits

Question

However, there were still several weaknesses in the legislature of this act. Which statements most accurately describe these weaknesses?
1. This law did not require drug manufacturers to prove that the drug was effective in its claims.
2. This law did not prevent drugs from being marketed for any disease.
3. This law required all drug labels to accurately describe their contents.
4. This law required adequate testing for safety prior to marketing.
5. This law did not encourage the development of drugs for rare or unusual disorders.

Answer 1

Correct Answer: 1,2
Rationale 1: The fact that manufacturers did not have to prove efficacy was a tremendous weakness in the regulation of drugs in the early 20th century.
Rationale 2: The PFDA of 1906 did not address false therapeutic claims.
Rationale 3: Requiring drug labels to identify their contents is not a weakness of the PFDA.
Rationale 4: The PFDA did not require testing for safety prior to marketing. It was not until Congress passed the Food, Drug, and Cosmetic Act that drugs had to be tested for safety prior to marketing.
Rationale 5: The act that encouraged the research and development of drugs for rare or unusual disorders is called the Orphan Act.
Global Rationale: The weaknesses of the PFDA of 1906 include the fact that manufacturers did not have to prove efficacy in the regulation of drugs in the early 20th century and the Act did not address false therapeutic claims. Requiring drug labels to identify their contents is not a weakness of the PFDA. The PFDA did not require testing for safety prior to marketing. It was not until Congress passed the Food, Drug, and Cosmetic Act that drugs had to be tested for safety prior to marketing. The act that encouraged the research and development of drugs for rare or unusual disorders is called the Orphan Act.