Europe also needs agency for postmarketing surveillance
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《英国医生杂志》
EDITOR—With respect to the withdrawal of rofecoxib (Vioxx), several months of debate on drug safety have focused on US policy, but very little has been said about the European situation.1 Some fundamental questions remain to be answered. For example, why did the manufacturer, and not the regulatory agencies, withdraw rofecoxib?
Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) had concluded, before this decision, that this product—and the other drugs belonging to the cyclo-oxygenase 2 inhibitor class—were essentially safe, and all that was needed was a few changes to the summary of the product characteristics, a document that is seldom read by prescribing doctors. This had happened before, for cerivastatin and other drugs, raising doubts about the regulatory agencies' efficiency in reaching decisions about benefit-risk ratios.
The American government has already decided to create an agency separate from the FDA, the Drug Safety Oversight Board, to monitor the toxicity of drugs after they have entered the market. In Europe, the European Commission has not reacted, probably because the EMEA reports to the Directorate General for Enterprise and Industry.
Several reasons exist to support the establishment of national and European agencies, not only to keep an eye on spontaneous reports from prescribers but also to take an active part in searching for drug induced toxicity. In Europe this agency should report to the Directorate General for Health and Consumer Protection (SANCO) and should be independent from the EMEA.
It is essential to establish a balance of power between approvals and withdrawals of drugs or restrictions of therapeutic indications to provide adequate information to doctors and the public and help counteract the pharmaceutical companies' monopoly of information.
Silvio Garattini, director
Istituto di Ricerche Farmacologiche "Mario Negri," Via Eritrea, 62, I-20157 Milan garattini@marionegri.it
Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) had concluded, before this decision, that this product—and the other drugs belonging to the cyclo-oxygenase 2 inhibitor class—were essentially safe, and all that was needed was a few changes to the summary of the product characteristics, a document that is seldom read by prescribing doctors. This had happened before, for cerivastatin and other drugs, raising doubts about the regulatory agencies' efficiency in reaching decisions about benefit-risk ratios.
The American government has already decided to create an agency separate from the FDA, the Drug Safety Oversight Board, to monitor the toxicity of drugs after they have entered the market. In Europe, the European Commission has not reacted, probably because the EMEA reports to the Directorate General for Enterprise and Industry.
Several reasons exist to support the establishment of national and European agencies, not only to keep an eye on spontaneous reports from prescribers but also to take an active part in searching for drug induced toxicity. In Europe this agency should report to the Directorate General for Health and Consumer Protection (SANCO) and should be independent from the EMEA.
It is essential to establish a balance of power between approvals and withdrawals of drugs or restrictions of therapeutic indications to provide adequate information to doctors and the public and help counteract the pharmaceutical companies' monopoly of information.
Silvio Garattini, director
Istituto di Ricerche Farmacologiche "Mario Negri," Via Eritrea, 62, I-20157 Milan garattini@marionegri.it