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U.S. Department of Health and Human Services


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Initiatives Underway To Expand Postmarketing Risk Assessment

Table of Contents: Managing the Risks from Medical Product Use: Creating a Risk Management Framework

Previous Section : FDA uses a number of approaches to assess Postmarketing Risk

Expanded postmarketing assessment

To reflect the increasing importance of postmarketing surveillance and risk assessment and to take into account the increased number of approvals each year, in the fall of 1998 the Center for Drugs expanded an existing division to create a new Office of Post-Marketing Drug Risk Assessment (OPDRA). The purpose of this new office is to plan, direct, and collaborate in the conduct of epidemiological studies to explore and confirm safety signals (see subsection below on safety signals), to assess risk, and to provide oversight for the monitoring of medication errors and other drug surveillance strategies. The staff is a multidisciplinary group of risk assessors and epidemiologists. One key task will involve identifying and assessing other databases that can be accessed to expand the Agency's epidemiological surveillance and regulatory impact studies.

Improved reporting

The under-reporting of adverse events and the often poor quality of data received from users are concerns shared by FDA's medical product centers. Much of the data FDA receives do not allow a complete understanding of the problems associated with an adverse event or allow the Agency to be proactive in protecting the public. Recently, FDA undertook a feasibility study to explore the barriers to reporting adverse events associated with the use of medical devices and to investigate various methods for overcoming those barriers. The working hypothesis of the feasibility study was that organizations well trained and educated in event recognition and reporting that receive support and feedback would be more likely to report events and also submit quality reports. Results of the study support the hypothesis. As already mentioned, the Modernization Act requires FDA to explore options for designing a national surveillance system based on a representative sample of medical device user facilities.

International activities

FDA participates in numerous international initiatives, such as those sponsored by ICH, to FDA mapped its premarketing review quality control functions according to the elements of the ISO 9001:2000 framework to ensure that FDA's system contains the elements necessary to understand and meet stakeholder needs. Each of the three centers prepared a detailed inventory of those procedures and processes that meet the specific elements in the ISO system. (See the general listing of relevant ISO elements in Appendix A.)

Because of the diverse products, legal requirements, and organizational structures that were to be audited, the audit focused on the existence and application of control systems. In every center, an extensive clearance process is relied on as part of the control system.

In addition, samples of recent product approval records from FDA's Center for Drugs, Center for Biologics, and Center for Devices were reviewed for their conformance to the existing QC standard operating procedures. set global standards for medical product manufacturers to meet in the postmarketing regulatory setting. Similar initiatives are underway for medical devices through the Global Harmonization Task Force (GHTF). These initiatives are designed to reduce duplication of effort and improve the quality of data being submitted. These efforts will also improve risk assessment by decreasing data entry time and shortening the time to complete review.

Electronic safety reporting

The vast majority (90 percent) of suspected adverse events are reported by health professionals to pharmaceutical manufacturers, who in turn report the information to the FDA. The design concept for AERS incorporates the international standards (ICH) for content, structure, and transmittal of individual case safety reports. AERS also was designed to enable manufacturers to submit their reports of suspected adverse drug reactions electronically; the electronic capability is being implemented in a step-wise fashion. When fully implemented, AERS electronic access capability will help integrate reporting of postmarketing safety information worldwide and expedite detection of safety problems for marketed drugs.

In conjunction with AERS development and implementation, FDA's Center for Drugs and Center for Biologics are currently conducting a pilot program involving the electronic submission of periodic reports from pharmaceutical firms. The pilot program is designed to develop and test the necessary processes, procedures, and technical architecture to implement the electronic submission of reports. This step-by-step program will help prepare for full-scale submission of reports in electronic format. The pilot initially included three major drug firms, and submissions were limited to one reporting form. To date, 13 firms have become involved in submitting test or production data. FDA has completed the initial phase of this pilot and now plans to expand the pilot to include additional manufacturers.8

Next Section : Other Efforts being Considered to Expand FDA's Postmarketing Risk Assessment