As reported in Fierce Biotech, a think tank known as the Pacific Research Institute (PRI) has recommended that the US FDA should also accept drug approvals from the EU's EMA. The group notes that the EU and FDA have approved a combined 39 drugs in the past two years. However, the 11 of these are exclusively approved in the EU, and the EU is averaging more than 3 months faster than its US counterpart in spitting out approvals.
The PRI says the FDA's monopoly regulatory position for US approvals is creating inefficiency and is blocking access to new drugs for Americans. Like most conservative groups, they'd prefer (or so they say) to see some healthy regulatory competition to speed the process - which they claim would likely save lives as well.
What that says about safety and efficacy criteria, I'm not sure, but I wouldn't hold my breath for lawmakers or the FDA to relinguish any regulatory control anytime soon.
Posted by Bruce Lehr July 28th 2010.