Orphan revise continues to move

WASHINGTON - The House Energy and Commerce Committee reported out Orphan Drug legislation (HR 4160) that includes "safe harbor" provisions guaranteeing seven years of market exclusivity for orphan drugs with revenues below a threshold.

The House bill is similar to a version pending in the Senate. All orphan drugs would be granted an initial four-year exclusivity period under both versions, with an additional three years granted to drugs deemed to have limited commercial potential...