Question

which legislation established standards for testing drug toxicity and monitoring labeling of drugs?

kefauver-harris act of 1962
comprehensive drug abuse prevention and control act of 1970
orphan drug act of 1983
federal food drug and cosmetic act of 1938

Explanation:

Identify the core question

The question asks which legislation established standards for testing drug toxicity and monitoring labeling of drugs.

Analyze the historical context of the options

• Kefauver-Harris Act of 1962: Passed in response to the thalidomide tragedy, this amendment to the Federal Food, Drug, and Cosmetic Act required drug manufacturers to prove both safety and effectiveness before marketing. It established strict standards for testing drug toxicity and monitoring drug labeling and advertising.
• Comprehensive Drug Abuse Prevention and Control Act of 1970: This act established the DEA schedules for controlled substances to regulate drugs with abuse potential.
• Orphan Drug Act of 1983: This act provided financial incentives for developing drugs to treat rare diseases.
• Federal Food Drug and Cosmetic Act of 1938: This act required drugs to be proven safe before marketing, but did not establish the specific rigorous efficacy and toxicity testing standards introduced in 1962.

Match the legislation to the prompt

The Kefauver-Harris Act of 1962 specifically mandated safety, efficacy, and toxicity testing standards, alongside strict regulation of drug labeling and advertising.

Answer:

• Kefauver-Harris Act of 1962 (Correct answer)
• Comprehensive Drug Abuse Prevention and Control Act of 1970
• Orphan Drug Act of 1983
• Federal Food Drug and Cosmetic Act of 1938