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Report slams US FDA's drug safety reform efforts
World Report
Report slams US FDA’s drug safety reform efforts A leaked report, which claims that the US Food and Drug Administration’s efforts to improve its computer system for tracking adverse effects of approved drugs have been seriously mismanaged, has triggered a Congressional investigation. Nellie Bristol reports. A report, sections of which had been leaked to the press, has triggered a Congressional investigation into the US Food and Drug Administration’s (FDA) efforts to reform its post-market drug surveillance system. The report describes an independent analysis by the Breckenridge Institute, based in Colorado, that concludes that the FDA’s efforts to improve its computer system for tracking adverse effects of approved drugs have been seriously mismanaged. As a result, the introduction of a new system will be delayed up to 5 years and cost US$25 million more than necessary, the report contends. The mismanagement is “frustrating and undermining” postmarket safety evaluators at the FDA “because they lack some of the basic tools they need to perform their jobs, eg a computing system that meets their requirements”, the report says.
Reuters
The printed journal includes an image merely for illustration
Senator Charles Grassley has asked the FDA Commissioner to release the full report
1072
Senate Finance Committee Chairman Max Baucus and ranking Republican Charles Grassley have asked FDA Commissioner Andrew C von Eschenbach to release the full report and to brief the Committee on its findings. The lawmakers also instructed the Inspector General, a government watchdog, to review the report. Investigators with a House of Representatives committee will also be considering the analysis, staff said. “We all rely on the FDA for drug safety, and this report raises some troubling questions about how wisely the FDA spends money and how well they’re protecting us”, Baucus said. The FDA’s difficulties in replacing its outdated and dysfunctional Adverse Event Reporting System (AERS) are caused mainly by management shortfalls, the Breckenridge Institute finds. In particular, the report cites problems with the FDA’s Center for Drug Evaluation and Research (CDER), the section responsible for the reform. “CDER’s culture can be characterised as one in which managers at all organisational levels fail to move from the awareness of organisational problems, to the kind of action that will produce positive change”, the report says. Breckenridge Institute researchers said delay of the new system, originally expected in 2005, results from consideration of an unnecessary mid-course shift in project design. The plan looked at expanding the system into an FDA-wide mechanism that would also track medical devices. The move, they say, is impeding availability of a more effective AERS. “This forces safety evaluators…to work with the dysfunction[al] AERS I system for yet another period of time, thus undermining their ability to
effectively carry out FDA’s mission of post-marketing surveillance and drug safety.” The report says the agency should have replaced AERS quickly and then used it as the foundation for an expanded system. An FDA spokeswoman would not comment on the report. The Senators say the report has to be taken seriously in light of other independent reviews that reached similar conclusions. For example, the Institute of Medicine (IOM), an independent research organisation, also criticised CDER’s culture in a September, 2006, report Drug Safety in the US, calling it “not optimally functional”. In explaining the need for post-approval drug tracking, the IOM report notes, “FDA approval does not represent a lifetime guarantee of safety and efficacy and what is newest is not always the best.” Drug mechanisms are complex, it says, and cannot always be predicted prior to approval. “ But epidemiologist Brian Strom, from the University of Pennsylvania School of Medicine, says allotting more resources to revamp AERS misses the boat in terms of developing an effective post-marketing drug surveillance mechanism. AERS, he says, consists mainly of a collection of anecdotes reported by drug manufacturers. He says that data are haphazard and enormously flawed. The system identifies only a tiny fraction of adverse reactions, he adds. Although AERS is essential for raising questions about drugs, it does not provide sufficient data to answer them, Strom argues. He recommends the agency instead devote resources to formal post-marketing studies.
Nellie Bristol www.thelancet.com Vol 369 March 31, 2007
Report slams US FDA’s drug safety reform efforts A leaked report, which claims that the US Food and Drug Administration’s efforts to improve its computer system for tracking adverse effects of approved drugs have been seriously mismanaged, has triggered a Congressional investigation. Nellie Bristol reports. A report, sections of which had been leaked to the press, has triggered a Congressional investigation into the US Food and Drug Administration’s (FDA) efforts to reform its post-market drug surveillance system. The report describes an independent analysis by the Breckenridge Institute, based in Colorado, that concludes that the FDA’s efforts to improve its computer system for tracking adverse effects of approved drugs have been seriously mismanaged. As a result, the introduction of a new system will be delayed up to 5 years and cost US$25 million more than necessary, the report contends. The mismanagement is “frustrating and undermining” postmarket safety evaluators at the FDA “because they lack some of the basic tools they need to perform their jobs, eg a computing system that meets their requirements”, the report says.
Reuters
The printed journal includes an image merely for illustration
Senator Charles Grassley has asked the FDA Commissioner to release the full report
1072
Senate Finance Committee Chairman Max Baucus and ranking Republican Charles Grassley have asked FDA Commissioner Andrew C von Eschenbach to release the full report and to brief the Committee on its findings. The lawmakers also instructed the Inspector General, a government watchdog, to review the report. Investigators with a House of Representatives committee will also be considering the analysis, staff said. “We all rely on the FDA for drug safety, and this report raises some troubling questions about how wisely the FDA spends money and how well they’re protecting us”, Baucus said. The FDA’s difficulties in replacing its outdated and dysfunctional Adverse Event Reporting System (AERS) are caused mainly by management shortfalls, the Breckenridge Institute finds. In particular, the report cites problems with the FDA’s Center for Drug Evaluation and Research (CDER), the section responsible for the reform. “CDER’s culture can be characterised as one in which managers at all organisational levels fail to move from the awareness of organisational problems, to the kind of action that will produce positive change”, the report says. Breckenridge Institute researchers said delay of the new system, originally expected in 2005, results from consideration of an unnecessary mid-course shift in project design. The plan looked at expanding the system into an FDA-wide mechanism that would also track medical devices. The move, they say, is impeding availability of a more effective AERS. “This forces safety evaluators…to work with the dysfunction[al] AERS I system for yet another period of time, thus undermining their ability to
effectively carry out FDA’s mission of post-marketing surveillance and drug safety.” The report says the agency should have replaced AERS quickly and then used it as the foundation for an expanded system. An FDA spokeswoman would not comment on the report. The Senators say the report has to be taken seriously in light of other independent reviews that reached similar conclusions. For example, the Institute of Medicine (IOM), an independent research organisation, also criticised CDER’s culture in a September, 2006, report Drug Safety in the US, calling it “not optimally functional”. In explaining the need for post-approval drug tracking, the IOM report notes, “FDA approval does not represent a lifetime guarantee of safety and efficacy and what is newest is not always the best.” Drug mechanisms are complex, it says, and cannot always be predicted prior to approval. “ But epidemiologist Brian Strom, from the University of Pennsylvania School of Medicine, says allotting more resources to revamp AERS misses the boat in terms of developing an effective post-marketing drug surveillance mechanism. AERS, he says, consists mainly of a collection of anecdotes reported by drug manufacturers. He says that data are haphazard and enormously flawed. The system identifies only a tiny fraction of adverse reactions, he adds. Although AERS is essential for raising questions about drugs, it does not provide sufficient data to answer them, Strom argues. He recommends the agency instead devote resources to formal post-marketing studies.
Nellie Bristol www.thelancet.com Vol 369 March 31, 2007