Question

The parent is concerned about giving a child medication because of the lack of knowledge about the effects of drugs on children. Legislation passed in 2012 about pediatric pharmacology. Which is true about this law?

a. It forbids providers from prescribing medications unless they have been U.S. Food and Drug Administration (FDA) approved for use in children.
b. It provides federal grants to fund pediatric pharmaceutical research.
c. It requires drug manufacturers to study pediatric medication use.
d. It mandates consistent, evidence-based dosing guidelines for use in children.

Answer 1

The 2012 legislation, known as FDASIA, requires drug manufacturers to study the safety and efficacy of medications in children. It does not restrict prescribers to only FDA-approved medications for children, nor does it provide grants for research. The anonymous losers in strict medical regulations are patients who face delays in accessing potentially beneficial drugs.

Step-by-step explanation:

The legislation passed in 2012 concerning pediatric pharmacology is the Food and Drug Administration Safety and Innovation Act (FDASIA). One of the provisions of this act, specifically Section 505B, mandates that drug manufacturers study medications for their safety and efficacy in children, which is known as pediatric studies.

This law does not forbid providers from prescribing medications unless they have been FDA approved for use in children, nor does it provide federal grants to fund pediatric pharmaceutical research.

While we can clearly see the winners of the FDA's regulations, which are those protected from unsafe drugs, the more anonymous losers who do not benefit from strict medical regulations are those who may experience delays in access to potentially beneficial drugs due to the extensive and time-consuming drug approval process.