The FDA Modernization Act contained several flaws, which led to ...

[abarnes]

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.

Question 2

In 1997, the Food and Drug Administration Modernization Act was passed. What was the rationale for this legislation?
 
  1. To prove that all adult medications are safe for children
  2. To improve testing and labeling of pediatric drugs
  3. To encourage the production of more pediatric drugs
  4. To generate higher profits for pharmaceutical companies marketing pediatric drugs

[rleezy04]

Answer to Question 1

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.

Answer to Question 2

Correct Answer: 2
Rationale 1: This was not the purpose of the legislation.
Rationale 2: The Food and Drug Administration Modernization Act was passed to improve testing and labeling of pediatric drugs.
Rationale 3: This was not the purpose of the legislation.
Rationale 4: There was a financial incentive for the research, but not for this purpose.
Global Rationale: The Food and Drug Administration Modernization Act was passed to improve testing and labeling of pediatric drugs. There was a financial incentive for the research, but not for this purpose.