A Breakthrough Therapies Pathway In Europe? Not Likely, Regulators Say
This article was originally published in RPM Report
Drug companies looking for a FDA-style Breakthrough Therapies pathway in Europe shouldn’t hold their breath: The current European health care reimbursement landscape, regulators say, cannot support a Breakthrough pathway. Europe is looking for other ways to shorten drug development times until the bigger-picture reimbursement question can be addressed. Is adaptive licensing the answer?
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Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?
A new FDA designation process for “breakthrough” drugs is one of the few “innovation” features of the FDA Safety & Innovation Act. It is likely to be very attractive to biotech sponsors, though its impact on actual product approvals is uncertain at best. The real “breakthrough,” though, may be in the collaborative model that led to the legislation – and that is an important message for sponsors hoping for bigger reforms ahead.