Over­seas dfrug and de­vice ap­provals

For new drugs and de­vices, a faster track to mar­ket of­ten found in Europe

Modern Healthcare - - Front Page - Jaimy Lee

Del­cath Sys­tems, a spe­cialty phar­ma­ceu­ti­cal and med­i­cal de­vice com­pany, won ap­proval for its tar­geted chemo­ther­apy de­liv­ery sys­tem in Europe this year. While Del­cath Pres­i­dent and CEO Ea­monn Hobbs says he ex­pects the chemosat­u­ra­tion sys­tem to re­ceive U.S. Food and Drug Ad­min­is­tra­tion ap­proval in mid-2012, the com­pany plans to move for­ward with plans to set up man­u­fac­tur­ing in a yet-to-be-dis­closed Euro­pean coun­try.

By hir­ing and in­stalling man­u­fac­tur­ing fa­cil­i­ties in Europe, New York-based Del­cath also is lay­ing the ground­work for the sys­tem to be avail­able in some grow­ing and emerg­ing mar­kets, Hobbs says. The sys­tem was ap­proved in Europe to treat tu­mors in the liver.

“We are go­ing to start man­u­fac­tur­ing in Europe in or­der to ac­cess emerg­ing mar­kets based on Euro­pean ap­proval,” Hobbs says. “Al­though we’re quite hopeful we’ll get (FDA) ap­proval next year, it’s never a guar­an­tee.”

Del­cath’s story is em­blem­atic of what ad­vo­cates of the phar­ma­ceu­ti­cal and med­i­cal de­vice in­dus­try say is the re­sult of an in­creas­ingly un­pre­dictable and slower ap­proval mar­ket in the U.S.

“I’ve never seen a more dif­fi­cult reg­u­la­tory en­vi­ron­ment to bring new in­no­va­tive tech­nolo­gies, both drug and de­vice, to pa­tients in the United States,” Hobbs says. “The risk pro­file of Europe is far more at­trac­tive be­cause the reg­u­la­tory process is far more pre­dictable.”

Sev­eral stud­ies pub­lished this year have ad­dressed shifts in the U.S. reg­u­la­tory en­vi­ron­ment, and specif­i­cally how U.S. ap­proval rates for drugs and med­i­cal de­vices, as com­pared with those in the Euro­pean Union, are far­ing.

The reg­u­la­tory process for the drug and de­vice mar­ket in Europe is struc­tured dif­fer­ently than the U.S. sys­tem. While the FDA has over­sight for drugs and de­vices in the U.S. mar­ket, the Euro­pean Medicines Agency is re­spon­si­ble for drug ap­provals, and de­vice com­pa­nies are re­quired to re­ceive CE Mark ap­proval, a stan­dard re­quire­ment for com­pa­nies in sev­eral in­dus­tries to mar­ket prod­ucts in 27 coun­tries in Europe.

Other dif­fer­ences in­clude the fact that re­im­burse­ment for drugs and de­vices is han­dled coun­try by coun­try. The de­vice mar­ket in Europe is over­seen by the Med­i­cal De­vices Direc­tive, the In-Vitro Di­ag­nos­tic Direc­tive and the Ac­tive Im­plantable Med­i­cal De­vice Direc­tive.

A re­port re­leased in Fe­bru­ary by the Cal­i­for­nia Health­care In­sti­tute, a pub­lic pol­icy or­ga­ni­za­tion based in La Jolla, and the Bos­ton Con­sult­ing Group found that from 2004 to 2006, new drugs were ap­proved first in the U.S. by an av­er­age of about seven months. By 2007, new drugs were ap­proved two months faster in the EU com­pared with the U.S.

The re­port also showed that high-risk med­i­cal de­vices, which go through a more strin­gent pre­mar­ket ap­proval process, are be­ing ap­proved al­most four years ear­lier in Europe as com­pared with the process in the U.S.

“The agency-in­dus­try part­ner­ship is strained by un­ex­plained reg­u­la­tory de­lays, by a lack of clear stan­dards for what clin­i­cal data are nec­es­sary for prod­uct ap­proval, and by a bu­reau­cracy whose com­mu­ni­ca­tions are nei­ther con­sis­tent nor pre­dictable,” wrote the au­thors about the process in the U.S. “The flight of med­i­cal tech­nol­ogy prod­uct launches to EU coun­tries should be a se­ri­ous cause for concern for pol­i­cy­mak­ers and pa­tient ad­vo­cates alike.”

Yet, three ed­i­tors at peer-re­viewed med­i­cal jour­nals and FDA of­fi­cials ar­gued that re­cent in­dus­try-funded re­ports, in­clud­ing the CHI re­port and an­other study con­ducted by re­searchers at Stan­ford Univer­sity, are flawed.

They found “ma­jor prob­lems” with both stud­ies, in­clud­ing the method­olo­gies, and ques­tioned whether the re­ports should serve as the ba­sis for pol­icy changes to the med­i­cal de­vice ap­proval process, ac­cord­ing to a House En­ergy and Com­merce Over­sight and In­ves­ti­ga­tions Sub­com­mit­tee memo re­leased ear­lier this month.

Be­com­ing risk-averse?

David Gol­la­her, pres­i­dent and CEO of the Cal­i­for­nia Health­care In­sti­tute, says the FDA’s shift to be­come more risk-averse, along with the re­cent eco­nomic chal­lenges and slow­down in the U.S. mar­kets, have cre­ated an en­vi­ron­ment that makes it in­creas­ingly dif­fi­cult for com­pa­nies to pur­sue FDA ap­proval.

“These fac­tors have come to­gether to change the busi­ness con­di­tions for med­i­cal de­vice com­pa­nies,” he says. “There’s been an over­all shift in the agency to be­come more and more con­ser­va­tive with re­spect to the ap­provals and that has slowed down the process dra­mat­i­cally.”

A Bos­ton Con­sult­ing Group re­port stated that some “high-pro­file de­vice re­calls” have led to an in­creased fo­cus on the ap­proval process in the U.S. Gol­la­her says the FDA has be­come more fo­cused on the di­rect risk of prod­ucts and of­ten re­quires more clin­i­cal data now.

As a re­sult, com­pa­nies are de­vel­op­ing strate­gies to launch their prod­ucts in Europe

Del­cath Sys­tems re­ceived reg­u­la­tory ap­proval in Europe

this year for its He­patic Che­mosat De­liv­ery Sys­tem, a

chemo­ther­apy sys­tem used to treat tu­mors in the liver.

The com­pany re­cently re­sub­mit­ted its ap­pli­ca­tion to the FDA and hopes to re­ceive ap­proval

in 2012.

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