GOP tax re­form bill would re­peal or­phan drug re­search cred­its

Re­pub­li­cans on Thurs­day rolled out their new tax re­form bill, which among oth­er pro­vi­sions to low­er tax­es for Amer­i­cans and busi­ness­es, pro­pos­es to re­peal a pro­vi­sion that might cause the bio­phar­ma in­dus­try some con­cern.

Un­der the House bill’s Sub­ti­tle E, sec­tion 3401 would re­peal what amounts to half of the qual­i­fied clin­i­cal re­search costs for des­ig­nat­ed or­phan drug prod­ucts.


Un­der the Or­phan Drug Act of 1983, Con­gress sought to in­cen­tivize the de­vel­op­ment of drugs to treat rare dis­eases by of­fer­ing drug­mak­ers tax cred­its, fee waivers and a sev­en-year pe­ri­od of mar­ket­ing ex­clu­siv­i­ty for an ap­proved or­phan in­di­ca­tion. To qual­i­fy for the des­ig­na­tion, a prod­uct must be in­tend­ed to treat a dis­ease that af­fects few­er than 200,000 peo­ple in the US, or more than 200,000 if the drug­mak­er can show that it is not ex­pect­ed to re­coup its costs to de­vel­op and mar­ket the drug.

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