FDA Leglislation Tackles Safety Issues - Biotech manufacturers face higher user fees plus more testing and data disclosure to prevent unsafe drug use - BioPharm International

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FDA Leglislation Tackles Safety Issues
Biotech manufacturers face higher user fees plus more testing and data disclosure to prevent unsafe drug use


BioPharm International
Volume 21, Issue 9

EXPANDING INFORMATION

A prime initiative for reducing drug safety problems is to modernize FDA's electronic information systems. User fees have supported improvements in the agency's IT infrastructure for new drug review and oversight; now PDUFA IV will provide added funds to establish an all-electronic regulatory submission and review environment over the next five years. The envisioned system will allow manufacturers to send in applications electronically with automated cross-links to previously submitted data, while FDA reviewers will be able to retrieve all relevant submissions and data and tools for searching and analyzing them. The goal is a system that can handle two-way transmission of regulatory correspondence.

A modern IT system also would improve FDA's current adverse event reporting system (AERS) for collecting and analyzing such reports from manufacturers, health professionals, and patients. In addition, Congress supports FDA efforts to build a more robust active surveillance system instead of relying on spontaneous adverse event reports to identify emerging safety problems. Additional resources will permit FDA to contract with government health programs and private health plans to access population-based epidemiological data on millions of patients to expand postmarketing drug surveillance. More collaboration with government and academic organizations and with the Centers for Education and Research on Therapeutics (CERTS) will enable FDA to learn more about how a treatment works in real-world postmarket circumstances, including the extent and outcomes of off-label drug uses.

PDUFA funds also will expand FDA staffing of epidemiologists, safety evaluators, and programmers who are able to use such IT resources. New research in this area should provide a better understanding of the role of epidemiologic analysis and use of databases in evaluating medical product safety.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,


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