Question

MedWatch reports help the FDA to:

A. monitor drug safety
B. shut down companies who make defective drugs
C. punish health care providers who administer defective medications
D. keep medication costs down

Answer 1

MedWatch reports help the FDA to monitor drug safety by providing a system for ongoing post-approval surveillance of medical products. While protecting consumers, extended regulation can also delay drug availability and increase costs, posing challenges for patients and companies.

Step-by-step explanation:

MedWatch reports help the FDA to monitor drug safety. The purpose of MedWatch, the FDA Safety Information and Adverse Event Reporting Program, is to enhance the agency's ability to protect the public from health hazards associated with the use of medical products. Reports submitted to MedWatch allow the FDA to ensure ongoing surveillance of products post-approval and take action if any safety concerns arise. Strict medical regulations by the FDA can mean that drug companies may need to conduct extensive testing, including postmarketing or Phase IV trials, as a condition of approval. While these regulations protect consumers from unsafe drugs, they may also lead to increased costs and delays in the availability of new drugs. The "losers" in this system can include patients who may miss out on potentially beneficial treatments while they are under prolonged review, as well as pharmaceutical companies who face financial and logistical challenges.