South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which act enhanced pediatric drug research requirements?

1. Drug Enforcement Administration Act

2. FDA Modernization Act

3. Drug Price Competition and Patent Term Restoration Act

4. Pediatric Research Equity Act

The correct answer is: FDA Modernization Act

The correct answer, which is the Pediatric Research Equity Act, specifically addresses the requirements for pediatric drug research. This act was designed to ensure that medications are studied in children and that their safety and efficacy are adequately evaluated before approval for pediatric use. It mandates that certain applications for new drugs include data on the safety and effectiveness of the drug in pediatric populations, thereby enhancing the focus on pediatric drug research and improving treatment options for children. The other acts mentioned focus on different aspects of drug regulation and market access: for instance, the FDA Modernization Act streamlined the drug approval process and encouraged the development of new drugs but did not specifically target pediatric research. The Drug Enforcement Administration Act is primarily concerned with controlled substances, while the Drug Price Competition and Patent Term Restoration Act is focused on the balance between patent protection for brand-name drugs and the introduction of generic drugs. Thus, these options do not enhance pediatric drug research specifically like the Pediatric Research Equity Act does.