West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

What law established the ANDA and the 505(b)(2) application (paper NDA) for generic drug approval, and established the Orange Book?

1. Durham-Humphrey Amendment of 1951

2. Food, Drug, and Cosmetic Act of 1938

3. Hatch-Waxman Act (Price Competition and Patent Act) of 1984

4. Kefauver Harris Amendment of 1962

The correct answer is: Durham-Humphrey Amendment of 1951

The correct answer is rooted in the significant legislative changes introduced by the Hatch-Waxman Act of 1984. This law was pivotal in the development of the Abbreviated New Drug Application (ANDA) and the 505(b)(2) application process, which streamlined the approval of generic drugs and certain new drugs that may not require full clinical data. Additionally, it established the Orange Book, officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations, which is a critical resource for pharmacists, healthcare providers, and manufacturers by providing information about drug products and their therapeutic equivalence. The other laws mentioned in the choices played essential roles in the history of drug regulation, but they do not cover the establishment of the ANDA or the Orange Book. For instance, the Durham-Humphrey Amendment of 1951 focused more on the prescription versus over-the-counter drug classification. The Food, Drug, and Cosmetic Act of 1938 was foundational in ensuring drug safety and efficacy but predated the current processes for generic drug approval. The Kefauver Harris Amendment of 1962 addressed drug efficacy and advertising but did not create the specific frameworks for generic drug applications that were established by the Hatch-Waxman Act.