Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
While the off-label use of medicines is appropriate for medical reasons – for example in pediatric care when no on-label treatment is available – concerns are growing that European doctors are being pushed to prescribe off-label medicines to reduce spending. Medicines used off-label are not systematically tested to the same stringent standards for the off-label indication that is required for authorized medicines. Member States promoting off-label use purely for economic reasons therefore put patients at unnecessary risk.
Furthermore, the promotion of off-label use for economic reasons undermines the innovative potential of all pharmaceutical companies in Europe and especially in France. In particular, small to medium-sized companies and those developing orphan medicinal products for rare diseases will be impacted by these developments. The French law counteracts ongoing efforts funded by Member States to boost innovation and research in Europe.
EUCOPE Secretary General Alexander Natz said: “The proposed French legislation not only conflicts with EU law and poses a significant impediment to our highly innovative members but most importantly puts patients at risk. We therefore call on the European Commission to stop national developments infringing EU law. We must adhere to the highest standards of patient safety enshrined in the EU’s regulatory framework and have to ensure that the use of medicines is driven by patients’ medical needs rather than budget considerations.”
For questions please contact email@example.com