House panel advances bills targeting rare disease, priority review vouchers

WASH­ING­TON — Law­mak­ers ad­vanced the reau­tho­riza­tion of an FDA pro­gram de­signed to stim­u­late the de­vel­op­ment of treat­ments for pe­di­atric rare dis­eases, de­spite some op­po­si­tion from De­mo­c­rat law­mak­ers.

Dur­ing the markup held on Thurs­day by the House En­er­gy and Com­merce Sub­com­mit­tee on Health, law­mak­ers de­bat­ed the reau­tho­riza­tion of the rare pe­di­atric vouch­er pro­gram, which em­pow­ers the FDA to dole out vouch­ers to spon­sors of pe­di­atric rare dis­ease drugs. Drug­mak­ers can ei­ther use the vouch­er for a sub­se­quent ap­pli­ca­tion or sell it to an­oth­er drug de­vel­op­er, with many fetch­ing about $100 mil­lion.

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