The Roles of the FDA in Protecting the Patient
Rasmussen College

Author Note This paper is being submitted on October 18, 2015, for Trang Nygyen’s PTN1009 Foundations of pharmacy practice.

The FDA Roles in Protecting the Patient
The current role of the FDA is to protect the public health by assuring the safety, efficacy and security of human and veternariny drugs, biological products, medical devices, our national food supply, cosmetics, and products that emit radiation.(“FDA Fundamentals, 2015”)

The FDA serves as a consumer watchdog, making sure that medications are safe and effective to help improve patient’s health. All new drugs are evaluated before they can be sold to ensure they work correctly and the health benefits outweigh known risks. FDA monitors and ensures safety of drugs after approval. (“What is the FDA’s role in drug safety”, 2010-2015)

Risk Evaluation and Mitigation Strategy (REMS) is used to manage a known or potential serious risk associated with a drug or biological product. REMS are required by the FDA if determined they are necessary. REMS include Medwatch, medication guide, and black labeling.(“REMS resource center, 2015”)

Medwatch is an FDA safety information and adverse event reporting program. The FDA uses REMS by communicating safety information by releasing Medwatch safety alerts to subscribers and through the Medwatch partner program. www.fda.gov/medwatch/safety The FDA posts monthly label changes on the web and distributes them via alert. Along with box warnings, contraindications, warnings and precautions, adverse reactions and patient inserts and medication guides.

Medication guides are included in the REMS. FDA requires these for certain prescription drugs that pose serious and significant public health concern. FDA approved patient information is necessary for sale and effective use. FDA determines if one or