US Activities in Risk Management of Pharmaceutical Products

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Chapter: Pharmacovigilance: US Activities in Risk Management of Pharmaceutical Products

The mission of the Food and Drug Administration (FDA) is to protect the public health by assuring the safety, efficacy and security of human drugs.


US Activities in Risk Management of Pharmaceutical Products

INTRODUCTION

The mission of the Food and Drug Administration (FDA) is to protect the public health by assuring the safety, efficacy and security of human drugs. FDA considers risk management to be a continuous process of (1) learning about and interpreting a product’s benefits and risks, (2) designing and implementing interventions to minimize a product’s risks, (3) eval-uating interventions in light of new knowledge that is acquired over time and (4) revising interventions when appropriate.

The avoidance of serious harm is the most commonly asserted justification for public health regulation (Gostin, 2000). Pharmaceutical risk management is the overall and continuing process of minimizing a drug’s risks throughout its life cycle to optimize its benefit/risk balance. Risk information emerges continuously throughout this life cycle, during both the investigation and marketing phases through both labelled and off-label uses.

This chapter will provide an overview of recent US regulatory activities in risk management and its evolving role in post-marketing surveillance of phar-maceutical products.

In May 1999, the Task Force on Risk Manage-ment issued its report to the Commissioner of FDA. Traditionally, FDA has filled several important roles in minimizing the risks associated with medical product use by establishing and enforcing product quality standards intended to prevent defective prod-ucts from reaching the market. Furthermore, this report challenged the traditional model by its care-ful analysis of the challenges faced in managing risks within the context of the broader healthcare delivery system (Figure 43.1).


FDA evaluates the safety profiles of drugs available in the United States using a variety of tools and disciplines throughout the life cycle of the drugs. Under US regulations,3 manufacturers of approved drug and biologic products are required to promptly report all adverse drug experience information obtained or otherwise received by the manu-facturer from any source, foreign or domestic, including information derived from commercial marketing experience, post-marketing epidemiologi-cal/surveillance studies, reports in the scientific liter-ature and unpublished scientific papers. FDA also accepts reports directly from healthcare providers and consumers. Currently, the agency’s adverse event database has over 3.5 million reports with increasing numbers reported annually (Figure 43.2).


This system of post-marketing surveillance report-ing [the adverse event reports system or adverse event reporting system (AERS)] and risk assessment programmes serves to identify adverse events that did not appear during the drug development process. The successful implementation of electronic submissions is a high priority for the center. Further improve-ments in this system include electronic submission of adverse drug reports that will result in more timely receipt and evaluation of adverse event reports at considerable cost savings both to FDA and to those submitting the reports. Data mining provides an important tool in facilitating signal detection of the more than three million reports in this database.

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