Legal Basis - United States
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During the decade of the 1990s, pharmaceutical regulation in the United States was dominated by a deter-mined focus to develop a more timely and efficient drug approval process.
Legal Basis - United
States
INTRODUCTION
During
the decade of the 1990s, pharmaceutical regulation in the United States was
dominated by a deter-mined focus to develop a more timely and efficient drug
approval process. This emphasis was advanced by an usual confluence of interest
by Congress, patient groups and the Food and Drug Administration (FDA).
By
contrast, the initial years of the twenty-first century have focused on drug
safety, perhaps in part a reaction to what occurred in the 1990s.
Risk-management plans, product monitoring, post-marketing surveillance and
accelerated withdrawals have become the new focus of that same confluence of
interests. Although innovative solutions are being discussed, and some will be
embraced, pharmacovig-ilance has been, and will remain, at the heart of drug
safety.
This
chapter will describe the legal basis and require-ments for pharmacovigilance
in the United States with regard to drugs and biological products. This chapter
will then review how the FDA enforces these requirements and the penalties for
non-compliance. For purposes of this chapter, pharmacovigilance means the
collection, analysis and submission to the FDA of adverse experiences and other
safety information related to drugs and biological products.
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