Lob­by­ing groups hun­grily eye fast-mov­ing FDA over­haul bill

Modern Healthcare - - NEWS - By Dar­ius Tahir

WASH­ING­TON—Why is the na­tion’s cap­i­tal sud­denly ob­sessed with bio­med­i­cal in­no­va­tion?

And why is the fruit of that ob­ses­sion, the 21st Cen­tury Cures Act, mov­ing like a greased pig through the usu­ally dead­locked Congress—even as some ex­perts warn it could un­der­mine the Food and Drug Ad­min­is­tra­tion’s abil­ity to pro­tect the public from un­proven and po­ten­tially un­safe new drugs and med­i­cal de­vices?

Last week, the House En­ergy and Com­merce Health Sub­com­mit­tee unan­i­mously ap­proved the markedup bill, send­ing it to the full com­mit­tee, which is sched­uled to con­sider it this week.

“This is a prod­uct de­serv­ing of the com­mit­tee’s sup­port,” said Rep. Frank Pal­lone (D-N.J.), who led Demo­cratic op­po­si­tion to the bill only a few months ago.

En­ergy and Com­merce Chair­man Fred Up­ton (R-Mich.) says he wants to pass the bill later this year.

But key sen­a­tors say they are work­ing on their own bill, which won’t be ready un­til at least the fall. There is no agree­ment yet on how to pay for the leg­is­la­tion’s costs or on whether to boost FDA fund­ing to help the agency han­dle its new obligations. There also are di­vi­sions over whether to grant drug­mak­ers longer mar­ket ex­clu­siv­ity for drugs treat­ing rare dis­eases.

The sweep­ing bill would over­haul fed­eral reg­u­la­tion of pre­scrip­tion drugs and med­i­cal de­vices. It also would pro­vide sig­nif­i­cantly more fund­ing to the Na­tional In­sti­tutes of Health, a move that brought Democrats on­board.

The over­haul bill would give the NIH $10 bil­lion in ad­di­tional manda­tory fund­ing over five years, as well as yearly in­creases, hik­ing the agency’s bud­get by $8 bil­lion by 2018 over cur­rent con­gres­sional ap­pro­pri­a­tions.

Ob­servers say nearly ev­ery sec­tor of the health­care in­dus­try has got­ten in­volved in lob­by­ing the bill.

Ac­cord­ing to the Se­nate’s lob­by­ing data­base, the num­ber of groups list­ing the 21st Cen­tury Cures Act as a lob­by­ing is­sue grew from 62 in the sec­ond quar­ter of last year to 222 in the first quar­ter of this year.

“It be­came a Christ­mas tree,” said Billy Wynne, of Thorn Run Part­ners, who has lob­bied the bill. “Many peo­ple see it as the moon­shot op­por­tu­nity for lots of stuff,” an­other lob­by­ist said.

Con­sumer ad­vo­cacy group Public Cit­i­zen called the NIH fund­ing a horse trade “pro­vid­ing perks to the phar­ma­ceu­ti­cal and med­i­cal-de­vice in­dus­tries to ap­prove med­i­ca­tions and de­vices faster based on weaker ev­i­dence.”

The feed­ing frenzy has at­tracted groups such as the Nat­u­ral Prod­ucts As­so­ci­a­tion, which lob­bies on di­etary sup­ple­ment is­sues. Its CEO, Daniel Fab­ri­cant, said the group hopes to gain cov­er­age for its mem­bers’ prod­ucts un­der tax-shel­tered health-sav­ings ac­counts and flex­i­ble-spend­ing ac­counts.

What has given the bill legs is the en­thu­si­as­tic sup­port of groups rep­re­sent­ing pa­tients with par­tic­u­lar dis­eases.

There’s a per­cep­tion that bio­med­i­cal in­no­va­tion is mov­ing too slowly, said Gre­gory Daniel, head of the Brook­ings In­sti­tu­tion’s phar­ma­ceu­ti­cal and med­i­cal-de­vice pol­icy group. “We’re mak­ing a lot of bench­top, pre­clin­i­cal break­through dis­cov­er­ies,” he said. “But we don’t see a lot of break­throughs trans­lat­ing into ther­a­pies.”

Un­der the bill, the FDA would be re­quired to strengthen its con­sid­er­a­tion of “real-world ev­i­dence” about the ef­fi­cacy of drugs.

Man­u­fac­tur­ers would be able to ex­pand a drug’s in­di­ca­tions based on ob­ser­va­tional data or reg­istries in­di­cat­ing how it per­forms in the field. The FDA also would be re­quired to de­velop more sur­ro­gate end­points to al­low shorter clin­i­cal tri­als.

For the de­vice in­dus­try, a “break­through de­vice” pro­gram would pro­vide a faster path to mar­ket for de­vices that might sub­stan­tially raise the stan­dard of care.

Dr. Mar­garet Ham­burg, who stepped down as FDA com­mis­sioner in March, has called the bill’s ap­proach mis­guided. She cau­tioned that plac­ing ad­di­tional re­quire­ments on the FDA will over­stretch the agency’s staff. Pal­lone and other Democrats have com­plained that the bill lacks ad­di­tional fund­ing for the FDA.

But some mem­bers of Congress ar­gue that more reg­u­la­tory flex­i­bil­ity is needed. Sen. Richard Burr (R-N.C.) said that for too many pa­tients, their treat­ment choices are be­tween “noth­ing and noth­ing.”

The Se­nate will de­velop its own bill that “col­lapses” the FDA’s prod­uct re­view times and the CMS’ time to ap­prove pay­ment for prod­ucts, Burr added.

Pal­lone ex­pressed con­cern about pro­posed longer mar­ket ex­clu­siv­ity in­cen­tives for drug­mak­ers, but noted that those pro­vi­sions were limited. Drug­mak­ers would get six ad­di­tional months of ex­clu­siv­ity for a drug with a new in­di­ca­tion for treat­ing a rare dis­ease. But, Pal­lone said, “I do not be­lieve com­pa­nies need more pro­tec­tion from com­pe­ti­tion to in­vest in the devel­op­ment of novel and in­no­va­tive drugs.” Other Democrats warn that longer ex­clu­siv­ity could boost health­care costs.

Some ex­perts ques­tion the need for re­vamp­ing the FDA ap­proval process. Ameet Sarpat­wari, a re­search fel­low at Brigham and Women’s Hos­pi­tal in Bos­ton, said the FDA has al­ready sped up its ap­provals, and now acts more quickly than Euro­pean reg­u­la­tory agen­cies.

“This is a prod­uct de­serv­ing of the com­mit­tee’s sup­port.” Rep. Frank Pal­lone (D-N.J.),

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