Chapter 10

At the end of the chapter, the reader will be able to:

1. Discuss the specific provisions of the Food and Drug Administration Amendments Act that address drug safety

2. Describe the scenarios under which the FDA requires postmarket studies and clinical trials to be conducted

3. Describe the various Risk Evaluation and Mitigation Strategies in place to minimize the occurrence of adverse events

4. Understand the FDA's efforts toward establishing a Postmarket Risk Identification and Analysis System

5. Discuss the potential role of health care providers in postmarket drug safety

Today, millions of people depend on medications to sustain their health. However, the consequence of this success is that many Americans are exposed to multiple prescription drugs each year (on average, more than 101), and many individuals, particularly the elderly, take more than five separate medications on a chronic basis. Because of such widespread use, an unanticipated drug safety problem can evolve into a public health risk. Until recently, the Food and Drug Administration (FDA)'s authority in regulating drug safety was mostly restricted to the pre-marketing stage of drugs. However, several concerns with postmarketing drug safety have been highlighted throughout the book, with the recall of several FDA-approved drugs. Alosetron was withdrawn and then returned to market with restrictions and a label warning. Troglitazone, propulsid, cerivastatin, rofecoxib, and valdecoxib have been withdrawn. Celecoxib and other nonselective, nonsteroidal, antiinflammatory drugs have had boxed warnings added to their labels. Additional warnings have been added to all antidepressant labels. The FDA identified the need to improve postmarket assessment of drug safety reporting and adverse drug reactions in a timely and efficient manner.

In 2005, the FDA asked the Institute of Medicine (IOM) to convene a committee to assess the U.S. drug safety system and to make recommendations to improve risk assessment, surveillance, and the safe use of drugs. As a result of the committee's work, in 2006, the IOM issued a report, The Future of Drug Safety—Promoting and Protecting the Health of the Public,2 which offered 25 recommendations. Some of these recommendations were directed to the FDA, particularly its Center for Drug Evaluation and Research (CDER). The CDER-directed recommendations proposed ways the agency could improve programs related to drug safety. Recommendations directed to governmental organizations other than the FDA discussed the development of a more robust and comprehensive system for ensuring the safe use of medical products. The remaining recommendations were directed to Congress and called for the FDA to have adequate authority to require postmarketing risk assessment and risk management programs. The IOM also recommended that Congress enact legislation to ensure compliance by pharmaceutical manufacturers for drug safety commitments by increasing the FDA's enforcement authority and tools to include fines, injunctions, and withdrawal of drug approval.3

In September 2007, Congress passed the Food and Drug Administration Amendments Act (FDA AA)4 to provide the FDA the authority and the resources to prevent, detect, and ...

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