Waxman's orphan proposal

WASHINGTON - Rep. Henry Waxman, D-Calif., has proposed changing the compromise Orphan Drug legislation to guarantee seven years of market exclusivity for drugs that do not exceed a cumulative sales amount determined by the secretary of Health and Human Services.

Under the original compromise to revise the law, all orphan drugs would receive at least four years of market exclusivity. Manufacturers could apply for an additional three years for drugs with demonstrated "limited commercial potential." Under the Waxman proposal, if sales fall below a defined threshold, the three-year extension would be automatic. ...