Under the FDA Act of 1988, what is expected to be reported to the FDA?

The correct answer is B, as the FDA Act of 1988 established guidelines for the surveillance of drug safety and efficacy. This legislation mandated reporting of all adverse drug reactions (ADRs) and outcomes associated with medications. The purpose of this requirement is to ensure that the FDA can monitor the safety profile of drugs once they are on the market, facilitating timely action if any significant safety concerns arise. The collection and analysis of ADR reports help the FDA assess the ongoing risks versus the benefits of drugs, allowing for informed regulatory decisions regarding labeling, warnings, and, if necessary, the withdrawal of a drug from the market.

Reporting only successful treatment outcomes or new medications would not provide a complete picture of a drug's safety and effectiveness. Similarly, while drug promotions and advertisements are regulated, they are not part of the adverse event reporting requirement established by the 1988 FDA Act. Therefore, the comprehensive approach of reporting all adverse drug reactions ensures patient safety and enhances post-market surveillance of pharmaceuticals.