Think tank: Let EMA-approved drugs onto U.S. market

Tools

Over the last two years the EMA and the FDA have approved a total of 39 new drugs. But 11 of those drugs are only available in Europe, where regulators also scored significantly faster approval times, shaving 97 days off the FDA average. And those stats spurred a think tank called the Pacific Research Institute to suggest that the U.S. would be far better off if it allows pharma companies the right to go ahead and start marketing drugs here once they get an approval over there.

"Clearly, Congress's grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans' timely access to new medicines," the institute says. The think tank argues it would like to get some healthy regulatory competition in play and probably save lives to boot. The Pacific Research Institute also thinks that Rep. Diane Watson's proposal to make experimental meds available to very sick patients with no other options is a tonic solution, notes The Hill.

It's a long shot at best, though, that this idea will ever get any kind of serious consideration. Lawmakers have shown little appetite for getting the FDA to actually hustle on approvals. Europe's reputation for faster, more aggressive regulatory action is likely to remain unchallenged, with the FDA's regulatory "monopoly" likely to continue indefinitely.

- read the report from the Pacific Research Institute
- here's the story from The Hill

Related Articles:
Feds reviewing new R&D incentives for rare diseases
FDA's chief scientist: time to build 'science of the future'
WSJ: FDA mapping new, faster path for cocktail drugs

Filed Under