The Food and Drug Administration's Use of Postmarketing (Phase IV) Study Requirements: Exception to the Rule?

Volume 61

61 FOOD AND DRUG LAW JOURNAL 295-384 (2006).

Postmarketing (Phase IV) studies have evolved over the course of thirty-five years from a rare exception to a comparatively routine part of how the Food and Drug Administration and drug sponsors navigate the drug approval process. This article analyzes the exogenous influences and internal agency dynamics that together have spurred this dramatic growth. The article also considers the tenuous statutory foundation supporting the bulk of Phase IV study requirements—often nominally “requests.” The article considers some of the problems that have arisen as postmarketing commitments have become more common and concludes by proposing a scheme for curtailing this trend while ensuring that drug sponsors do in fact complete critical studies.

May 2006