21st Cen­tury Cures a bi­par­ti­san bat­tle on dis­ease

The Denver Post - - OPINION - By Diana DeGette Diana DeGette rep­re­sents Colorado’s First Con­gres­sional Dis­trict to Washington D.C., where she is a se­nior mem­ber of the House En­ergy and Com­merce Com­mit­tee.

With pas­sage in the House of Rep­re­sen­ta­tives of the 21st Cen­tury Cures Act that I co-au­thored with Michi­gan Repub­li­can Rep. Fred Upton, we’re just two steps away from a ma­jor vic­tory for U.S. re­search into causes and treat­ments for dis­ease. The next few days will de­cide its fate as the U.S. Se­nate pre­pares to vote.

More than 700 groups rep­re­sent­ing pa­tients, health care providers, re­searchers and oth­ers have voiced sup­port for the bill – as has the White House, which pro­vided its en­thu­si­as­tic en­dorse­ment be­fore and just af­ter the House ap­proved it by a vote of 392 to 26.

And this very news­pa­per weighed in, too, not­ing that the mea­sure is in­tended to make fed­eral re­view of re­search more ef­fi­cient.

This is a wa­ter­shed mo­ment in this coun­try for bio­med­i­cal re­search. With this bill, we bring hope to mil­lions of pa­tients who suf­fer from can­cer, Alzheimer’s, di­a­betes and a host of other ail­ments.

Upton and I started work­ing on this mea­sure three years ago. We trav­eled the coun­try to­gether to gather in­for­ma­tion about much-needed re­forms, and we had tremen­dous par­tic­i­pa­tion in the process from pa­tients groups, med­i­cal pro­fes­sion­als, academia, and fed­eral and state health care author­i­ties. The con­sen­sus view was es­pe­cially im­por­tant as we strove to strike a bal­ance be­tween clear­ing away the hur­dles to progress and en­sur­ing safety and ef­fi­cacy of drugs and de­vices re­main our paramount stan­dard.

All of this led to our orig­i­nal bill, which passed the House in July 2015 by 344 to 77. We have worked tire­lessly in a bi­par­ti­san, bi­cam­eral way since then to im­prove and ex­pand the bill and to smooth the way to­ward pas­sage through the Se­nate and on to the pres­i­dent’s desk.

The re­sult will help over­come ob­sta­cles to med­i­cal progress — from dis­cov­ery to de­vel­op­ment to de­liv­ery — through in­vest­ing in in­no­va­tion, in­cor­po­rat­ing the pa­tient per­spec­tive and mod­ern­iz­ing clin­i­cal tri­als.

Among the key pro­vi­sions, this con­sen­sus ver­sion of the bill will:

•Pro­vide $4.8 bil­lion to the Na­tional In­sti­tutes of Health, in­clud­ing money for Vice Pres­i­dent Bi­den’s can­cer moon­shot ini­tia­tive, and in­clud­ing money for pre­ci­sion medicine and the brain ini­tia­tive.

•Al­lo­cate al­most $1 bil­lion in grants to the states, in­clud­ing Colorado, to ad­dress the ur­gent opi­oid cri­sis in this coun­try.

•Re­move the si­los at the Food and Drug Ad­min­is­tra­tion by tran­si­tion­ing it to a dis­ease-cen­tric ap­proach, and it gives $500 mil­lion so the FDA can im­ple­ment these re­forms.

•In­clude all im­por­tant mental health leg­is­la­tion that we’ve worked to shape and to pass into law for a long time.

•Cat­alyze cut­ting-edge re­search by sup­port­ing po­ten­tially trans­for­ma­tive ef­forts.

21st Cen­tury Cures will help sci­en­tists in our re­gion and through­out the United States work to­gether on re­search projects. At the mo­ment, each school has to fol­low its own set of pro­to­cols for clin­i­cal and field stud­ies, even when the schools col­lab­o­rate.

This cum­ber­some process can be stream­lined so that schools such as the Univer­sity of Colorado School of Medicine and other re­search in­sti­tu­tions can col­lab­o­rate without fol­low­ing sep­a­rate ap­proval tracks for their re­search mod­els.

All of this, done in close con­sul­ta­tion with the agen­cies that are re­spon­si­ble for the safety of med­i­cal re­search in this coun­try, will bring hope to mil­lions of Amer­i­cans.

At a time of height­ened ac­ri­mony in Washington, and in the wake of one of the most ran­corous elec­tions we’ve ever had, it’s won­der­ful that we can come to­gether to find cures that af­fect so many pa­tients and their loved ones.

Dis­ease doesn’t dis­crim­i­nate ac­cord­ing to po­lit­i­cal party. It knows noth­ing of claims and counter-claims. It re­sponds only to care­fully de­vel­oped treat­ments and cures.

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