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The Future of Drug Safety: Promoting and Protecting the Health of the Public
3.5: To restore appropriate balance between the FDA’s dual goalsof speeding access to innovative drugs and ensuring drug safety overthe product’s lifecycle, the committee recommends that Congressshould introduce specific safety-related performance goals in thePrescription Drug User Fee Act IV in 2007. (See Chapter 3 for suggested goals.)
Science and Expertise
FDA’s Adverse Event Reporting System (AERS) is outdated and inefficient, and although CDER has begun a technological overhaul of the system, more work is needed to improve its usefulness in postmarketing surveillance.
4.1: The committee recommends that in order to improve the generation of new safety signals and hypotheses, CDER (a) conduct asystematic, scientific review of the AERS system, (b) identify andimplement changes in key factors that could lead to a more efficientsystem, and (c) systematically implement statistical-surveillancemethods on a regular and routine basis for the automated generation of new safety signals.
In addition, CDER’s ability to test drug safety hypotheses is limited.
4.2: The committee recommends that in order to facilitate the formulation and testing of drug safety hypotheses, CDER (a) increasetheir intramural and extramural programs that access and studydata from large automated healthcare databases and (b) include inthese programs studies on drug utilization patterns and backgroundincidence rates for adverse events of interest, and (c) develop andimplement active surveillance of specific drugs and diseases asneeded in a variety of settings.
The report makes several recommendations (4.3, 4.5, 4.8, and 5.4 below) intended to help CDER develop a more structured way to determine the level of postmarketing scrutiny and data requirements, in other words, to match the evaluation of drugs with the way that they will be used in the population. Short-term preapproval trials do not provide adequate information about the balance of risks and benefits of drugs that are used by many people for many years.
Various public- and private-sector organizations possess increasingly high-quality data resources and scientific capacity, and a concerted effort is