The FDA Modernization Act contained several flaws, which led to the passage of the Best Pharmaceuticals for Children Act in 2002. What was the major flaw in the Modernization Act?
1. Profits for studying off-patent drugs were higher.
2. Congress controlled the choice of drugs that the pharmaceutical companies were allowed to study.
3. Drugs were chosen for research based on their potential value for children.
4. Drugs were chosen for research based on their financial benefits to the pharmaceutical companies.
Correct Answer: 4
Rationale 1: There were higher profits for studying on-patent, not off-patent, drugs.
Rationale 2: Congress did not choose the drugs to be researched; that decision was left to the pharmaceutical companies.
Rationale 3: Most of the drugs that were studied were chosen because of financial benefits, not for their potential value to pediatric drug research.
Rationale 4: Most of the drugs studied were in adult drug classes. The main rationale for the pharmaceutical companies' choice of drugs for the studies was financial.
Global Rationale: Most of the drugs studied were in adult drug classes. The main rationale for the pharmaceutical companies' choice of drugs for the studies was financial. There were higher profits for studying on-patent, not off-patent, drugs. Congress did not choose the drugs to be researched; that decision was left to the pharmaceutical companies. Most of the drugs that were studied were chosen because of financial benefits, not for their potential value to pediatric drug research.
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