FDA over­haul bill moves ahead af­ter fund­ing deal

Modern Healthcare - - NEWS - By Steven Ross John­son

Sweep­ing leg­is­la­tion to over­haul the na­tion’s drug and de­vice ap­proval process and boost med­i­cal re­search fund­ing raced ahead last week in the House of Rep­re­sen­ta­tives.

The House En­ergy and Com­merce Com­mit­tee voted unan­i­mously Thurs­day to move the 21st Cen­tury Cures Act to the full House for con­sid­er­a­tion af­ter law­mak­ers reached agree­ment on pay-fors for its es­ti­mated $13 bil­lion cost over 10 years. “Ev­ery sin­gle mem­ber here on both sides of the aisle has some­thing in this bill,” said com­mit­tee chair­man Fred Up­ton (R-Mich.).

The bill would pro­vide more than $10 bil­lion over five years to the Na­tional In­sti­tutes of Health, as well as $550 mil­lion in added funds to the Food and Drug Ad­min­is­tra­tion to help it han­dle the re­vised ap­proval process.

Se­nate lead­ers plan to craft their own bio­med­i­cal in­no­va­tions bill, though they say it won’t be ready un­til the fall at the ear­li­est.

Law­mak­ers were wor­ried about po­ten­tial cuts to Medi­care and Med­i­caid to off­set the bill’s costs. In­stead, law­mak­ers agreed to fund the bill from the sale of crude oil from the Strate­gic Petroleum Re­serve, as well as from lim­it­ing Med­i­caid rates for some durable med­i­cal equip­ment to Medi­care rates.

The deal also would al­ter the tim­ing of rein­sur­ance pay­ments to Medi­care Part D pre­scrip­tion drug plans to re­duce ac­crued in­ter­est. Amer­ica’s Health In­sur­ance Plans op­poses that pro­vi­sion.

A con­gres­sional aide said on back­ground that a de­tailed es­ti­mate of how much money each pay-for would gen­er­ate will come in a few weeks.

Sup­port­ers say the Cures Act would speed life-sav­ing in­no­va­tions in drugs and de­vices. Crit­ics ar­gue that the bill would heighten the risk for pa­tient harm by loos­en­ing ap­proval stan­dards and that it could in­crease health­care spend­ing for prod­ucts of mar­ginal value.

A key pro­vi­sion would al­low the FDA to grant mar­ket ap­proval for a drug based on early stage testing for safety and ef­fec­tive­ness.

De­vice­mak­ers would be able to ap­ply for a “break­through des­ig­na­tion” path­way for prod­ucts that treat con­di­tions where no al­ter­na­tive ex­ists or that sig­nif­i­cantly im­prove on ex­ist­ing ther­a­pies.

The FDA also would be re­quired to es­tab­lish a process for the use of sur­ro­gate mark­ers in clin­i­cal tri­als, cut­ting the time needed for get­ting re­sults from drug tri­als.

A con­tro­ver­sial pro­posal to lengthen mar­ket ex­clu­siv­ity for some new med­i­ca­tions was sig­nif­i­cantly scaled back. In ad­di­tion, lan­guage to tighten con­trols over the 340B pro­gram giv­ing hos­pi­tals serv­ing low-in­come and unin­sured pa­tients a dis­count on drugs was re­moved.

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