House OKs bill bol­ster­ing med­i­cal re­search, drug ap­provals

Kuwait Times - - HEALTH & SCIENCE -

The House eas­ily ap­proved a sweep­ing biomed­i­cal bill Wed­nes­day that would help drug and med­i­cal de­vice com­pa­nies win swifter gov­ern­ment ap­proval of their prod­ucts, boost disease re­search and drug-abuse spend­ing and re­vamp fed­eral men­tal health pro­grams.

The com­pro­mise, which en­vi­sions spend­ing $6.3 bil­lion over the next decade, was con­demned by con­sumer groups and some Democrats as a present to drug­mak­ers that promised only pal­try spend­ing in­creases for un­der­funded fed­eral pro­grams.

But their ob­jec­tions were over­whelmed by an al­liance among Repub­li­cans, many Democrats and the White House for a 996-page mea­sure that bore wins for both par­ties. The Sen­ate’s ex­pected fi­nal ap­proval next week would mark an un­com­mon episode of co­op­er­a­tion be­tween the GOP-run 114th Congress - which plans to ad­journ next week - and Pres­i­dent Barack Obama in their dwin­dling days in of­fice.

The vote was 392-26

“We are on the cusp of some­thing spe­cial, a once-in-a-gen­er­a­tion op­por­tu­nity to trans­form how we treat disease,” said Rep. Fred Up­ton, RMich., chair­man of the House En­ergy and Com­merce Com­mit­tee and an au­thor of the leg­is­la­tion.

Not ev­ery­one agreed

Rep. Rose DeLauro, D-Conn., said that while the bill con­tained “no­ble goals that I share,” its re­lax­ation of some stan­dards for fed­eral drug ap­provals was dan­ger­ous and “ne­glects the very peo­ple clin­i­cal tri­als are meant to help, that is the pa­tients.”

No. 2 Sen­ate Demo­cratic leader Richard Durbin of Illi­nois said he was “to­tally un­der­whelmed” by the bill’s ex­tra money, and said its cuts in a disease preven­tion fund cre­ated un­der Obama’s health care law to fi­nance new med­i­cal re­search dis­played “a warped sense of jus­tice.”

But Demo­cratic hopes - and lever­age - for win­ning more money and con­sumer pro­tec­tions faded with Repub­li­can Don­ald Trump’s pres­i­den­tial elec­tion tri­umph. Sen­ate Ma­jor­ity Leader Mitch McCon­nell, R-Ky., flatly said his cham­ber will send the mea­sure to Obama, and Durbin said he ex­pected Sen­ate pas­sage.

In a writ­ten state­ment, White House spokesman Josh Earnest said the bill “is not per­fect” but con­tains “ad­vances in health that far out­weigh these con­cerns.” He said the Sen­ate should ap­prove it quickly.

The bill in­cludes an ad­di­tional $4.8 bil­lion over the next 10 years for the Na­tional In­sti­tutes of Health. The med­i­cal re­search agency spends around $32 bil­lion an­nu­ally, and sup­port­ers com­plain that spend­ing cuts im­posed by Congress and ris­ing re­search costs mean its bud­get has eroded in value since the early 2000s. “A cou­ple bil­lion dol­lars doesn’t go very far in cancer re­search” over 10 years, said Lisa Ply­mate, a di­rec­tor of the lib­eral-lean­ing Na­tional Physi­cians Al­liance. Much of the NIH money would be for Obama’s pre­ci­sion medicine ini­tia­tive, aimed at tailor­ing drugs for peo­ple’s genes and life­styles, and re­search on cancer, a fo­cus of Vice Pres­i­dent Joe Bi­den, whose son Beau died of the disease in 2015.

The bill would also sharpen the fed­eral fo­cus on men­tal health ef­forts, such as cre­at­ing new posts for gov­ern­ment of­fi­cials who would co­or­di­nate such ini­tia­tives. But it has lit­tle new money for those pro­grams. “We didn’t get ev­ery­thing we needed,” said Rep. Tim Mur­phy, R-Pa., spon­sor of those pro­vi­sions. “We’ll keep push­ing that.”

The mea­sure in­cluded funds and an ac­cel­er­ated Food and Drug Ad­min­is­tra­tion ap­proval process for tech­niques aimed at re­gen­er­at­ing cells. McCon­nell has sup­ported those pro­vi­sions, but crit­ics have con­demned the treat­ments as in­ef­fec­tive.

The Food and Drug Ad­min­is­tra­tion would get $500 mil­lion to stream­line ap­proval pro­cesses for drugs and med­i­cal de­vices. States would get $1 bil­lion over the next two years for pre­vent­ing and treat­ing abuse of ad­dic­tive drugs like opi­oids, a prob­lem that is surg­ing in GOP and Demo­cratic rep­re­sented com­mu­ni­ties around the coun­try. “The No. 1 thing we can do right now is to make sure we’re ded­i­cat­ing re­sources to ex­pand ac­cess to treat­ment all across the coun­try,” Michael Bot­ti­celli, di­rec­tor of the White House’s Of­fice of Na­tional Drug Con­trol Pol­icy, said in a con­fer­ence call with re­porters.

— AP

MACKINAC IS­LAND, Michi­gan: In this Sept 19, 2015, file photo Rep. Fred Up­ton, R-Mich., is seen dur­ing a con­gres­sional panel at the 2016 Mackinac Repub­li­can Lead­er­ship Con­fer­ence.

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