Must-pass user fee deals: Bio­phar­ma com­pa­nies fund more than 80% of FDA's re­view staff, CDER head tells Con­gress

Every five years, the FDA and bio­phar­ma in­dus­tries ne­go­ti­ate an agree­ment ex­plain­ing how much the com­pa­nies will need to pay in so-called user fee funds, as well as what goals the FDA has to meet in its prod­uct re­views.

But even af­ter those agree­ments have been hashed out, Con­gress still has to au­tho­rize the user fee agree­ments some­time be­fore the cur­rent agree­ments ex­pire in Sep­tem­ber.

The House En­er­gy & Com­merce sub­com­mit­tee on health held a hear­ing on the re-au­tho­riza­tions Thurs­day, and rep­re­sen­ta­tives on both sides of the aisle ex­pressed agree­ment on the im­por­tance of the time­ly reau­tho­riza­tion of these user fees.

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