Sen­ate bill to cut health costs, tar­gets FDA tweaks

The Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions (HELP) com­mit­tee on Thurs­day un­veiled a dis­cus­sion draft of a new wide-rang­ing bill to help cut health care costs.

The draft in­cludes nine sec­tions re­lat­ed to the FDA, in­clud­ing ef­forts mir­ror­ing House-passed bills re­form­ing the Or­ange Book and Pur­ple Book, as well as ini­tia­tives to in­crease gener­ic drug com­pe­ti­tion.

For­mer FDA Com­mis­sion­er Scott Got­tlieb praised the Sen­ate draft: “These mea­sures WILL low­er prices. The most tan­gi­ble set of bi­par­ti­san re­forms to emerge.”

Among the pro-com­pet­i­tive pro­vi­sions, the draft seeks to pre­vent first-to-file gener­ic drug ap­pli­cants from block­ing, be­yond the 180-day ex­clu­siv­i­ty pe­ri­od grant­ed by the FDA, the en­trance of sub­se­quent gener­ics. An­oth­er pro­vi­sion would al­so trig­ger the start of the first-to-file gener­ic drug ap­pli­cant’s 180-day ex­clu­siv­i­ty when a sub­se­quent ap­pli­cant has been ten­ta­tive­ly ap­proved and the first-to-file ap­pli­cant has not re­ceived fi­nal ap­proval with­in 30 months of sub­mit­ting its ap­pli­ca­tion.

The bill al­so tight­ens the de­f­i­n­i­tion for el­i­gi­bil­i­ty for five-year new chem­i­cal en­ti­ty (NCE) ex­clu­siv­i­ty to pre­vent ever­green­ing, clar­i­fy­ing that the ex­clu­siv­i­ty is avail­able on­ly for a drug con­tain­ing no ac­tive moi­ety that has been pre­vi­ous­ly ap­proved in the US.

Sev­er­al oth­er pro­vi­sions would al­so help biosim­i­lar man­u­fac­tur­ers.

For in­stance, the bill would pre­vent de­lays re­lat­ed to com­pli­ance with USP stan­dards by ex­clud­ing all bi­o­log­ics sub­ject to reg­u­la­tion un­der the Pub­lic Health Ser­vice Act from re­quire­ments to fol­low USP com­pen­di­al stan­dards.

The bill al­so ad­dress­es the tran­si­tion next March for cer­tain bi­o­log­ics ap­proved un­der new drug ap­pli­ca­tions, clar­i­fy­ing that such prod­ucts, in­clud­ing in­sulin prod­ucts, can­not re­ceive new, ex­tend­ed mar­ket ex­clu­siv­i­ties.

At the same time, the bill pre­serves cer­tain un­ex­pired ex­clu­siv­i­ties for bi­o­log­ics un­der­go­ing the tran­si­tion and en­sures that mar­ket­ing ap­pli­ca­tions sub­mit­ted six months pri­or to the tran­si­tion that are still un­der FDA re­view at the time of the tran­si­tion date will not have to be re­sub­mit­ted.

The bill al­so goes af­ter phar­ma­cy ben­e­fit man­agers (PBMs), pre­vent­ing them from en­gag­ing in spread pric­ing, or charg­ing a plan spon­sor, health in­sur­ance plan or pa­tient more for a drug than the PBM paid to ac­quire the drug. An­oth­er pro­vi­sion would re­quire PBMs to pass on 100% of any re­bates or dis­counts to the plan spon­sor.

Sep­a­rate­ly, the House Ways & Means Com­mit­tee float­ed a draft bill on Thurs­day to es­tab­lish an out-of-pock­et cap for Medicare ben­e­fi­cia­ries.

Dis­cus­sion Draft


First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

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