PharmaTimes | Industry News | World News | US patients “should have EU-approved drugs”: "If, during a 12-month period in 2008 and 2009, the US government had allowed American patients to use new medicines that were approved by the European Medicines Agency (EMA) but not yet by the Food and Drug Administration (FDA), American patients would have had faster access to 17 new medicines out of the entire set of 39, according to the report, published this week by the Pacific Research Institute (PRI), a free-market public policy think tank.
During the 12-month review period, the EMA and the FDA approved a total of 39 new medicines. 15 were approved only by the FDA, 11 were approved only by the EMA and 13 were approved by both regulators. In five of the 13 cases where the FDA and EMA both approved the medicine, the EMA was the first to approve, and it issued those approvals 552 days faster than the FDA, on average. Even if all 13 medicines approved by the FDA and the EMA, the EMA approved those 97 days faster, on average, says report author John Graham.
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