RAPS News: Europe provides a monthly snapshot of important news and developments that impact the healthcare product regulatory environment, with a particular emphasis on Europe.
Pharmaceutical Technology
The European Medicines Agency (EMA) performed a study indicating that statistical techniques using EMA's EudraVigilance database of adverse drug reaction reports can be employed to identify drug safety issues "significantly earlier" compared with routine pharmacovigilance. EMA used a statistical signal-detection method in the EudraVigilance database and learned that safety issues could be detected earlier in more than half of cases where a clinically important adverse drug-reaction report was found, versus routine pharmacovigilance. An EMA press statement says the study "provides direct evidence for a strong additive role of EudraVigilance signal-detection methods." In addition, EMA says the study underscores the value of well-established pharmacovigilance systems such as active surveillance or periodic safety-update reporting, and reaches the conclusion that "a combination of routine pharmacovigilance and statistical signal detection provides the optimal safety monitoring with earlier detection and better management of safety issues." EMA currently utilizes the practice to fortify signal detection for centrally authorized medicines with the goal of spotting new or changing safety issues with medicines earlier than previously.
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PharmaTimes
The European Medicines Agency's refusal to allow researchers to access trial documents relating to two anti-obesity drugs is an example of maladministration, according to the European Ombudsman. In his second decision against EMA in two months, Ombudsman Nikiforos Diamandouros called on EMA to give researchers access to the clinical study reports and trial protocols relating to orlistat, from Roche's Xenical and GlaxoSmithKline's over-the-counter product Alli, and rimonabant, from Sanofi-Aventis' now-withdrawn Acomplia. The case goes back to 2009, when researchers at the Nordic Cochrane Centre for research and information asked EMA for access to the documents, arguing that access was essential for independent analysis. EMA refused the request on the grounds that granting access would undermine the commercial interests of the drug's manufacturers. The researchers countered that it was unlikely that clinical study reports would contain anything that could undermine commercial interests, and asked the agency to explain why it believed commercial interests of the drug should override the welfare of patients. The Ombudsman concluded that the documents at issue did not contain information on the composition of either orlistat or rimonabant, or any other commercially confidential information, and that disclosure would not undermine commercial interests. Diamandouros says EMA has not provided sufficient reasons to refuse access to the requested documents, and that its failure to do so amounts to maladministration.
Wall Street Journal
The head of the European Medicines Agency (EMA) says that Europe's financial difficulties will most likely result in cuts to EMA's budget, and as a result the agency will probably have to increase fees for pharmaceutical companies. EMA has already received about 80 percent of its 217-million-euro budget from companies that pay fees to have their products reviewed for marketing approval, while the remaining 20 percent comes from the European Commission (EC). There are some signs that the EC may cut its contributions to EMA by about 10 million euros. EMA head Thomas Lonngren says in conversations with drug companies he has already "alluded" to the possibility that fees could rise. Lonngren states that he does not feel that increased industry funding will hurt EMA's independence, though he did say that budget cuts may force the agency to delay some investments, including improvements to its information-technology systems. Lonngren warns that the financial crises may have resulted in a rise in poorly prepared applications from drug companies, and that companies may have rushed applications because they were short on money or wanted to increase share prices or sell to larger companies. "I think it's quite unethical when companies make these shortcuts because they are exposing patients to unnecessary clinical trials," says Lonngren. "And they are occupying a lot of valuable resources here at the regulator that we could use in a better way."
PharmExec.com
European pharmaceutical companies have been critics of England's National Institute for Health and Clinical Excellence (NICE), fearing that NICE's judge-and-jury character confers an unacceptable level of unchallenged authority on the guidance it issues about what constitutes value for money spent. Now, Thomas Lonngren, the executive director of the European Medicines Agency (EMA), is voicing his concern over bodies like NICE. Lonngren says the EU ideal of a single market for pharmaceuticals has been "broken" by the sort of health technology assessments typified by NICE, and that patient access is being impeded by what he sees as new product approval mechanisms based on cost-effectiveness. Lonngren says his agency will be unable to fulfill its responsibilities for patient safety if other authorities are encouraging the use of a product in areas where no risk-benefit evaluation has been made. Industry representatives are supporting Lonngren's message. As an example, Lonngren points to UK health officials urging NICE to conduct an evaluation of off-label usage of Avastin in age-related macular degeneration.
European Medicines Agency
The European Medicines Agency (EMA) has signed a cooperation agreement with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). The new arrangement between the two agencies furthers cooperation and boosts exchange of information and expertise on psychoactive substances. The EMCDDA will report on an ad hoc basis to EMA on any misuse of medicinal products detected through its networks, complementing information gathered through the EU pharmacovigilance system. EMA will, in turn, be able to provide ad hoc reports to the EMCDDA on the misuse of authorized medicinal products.
