In the hot seat

Modern Healthcare - - The Week In Healthcare - Mau­reen McKinney

AS­tudy ques­tions FDA’s fast-track process sear­ing anal­y­sis of the Food and Drug Ad­min­is­tra­tion’s med­i­cal-de­vice ap­proval process has drawn wide­spread at­ten­tion as well as a quick re­sponse from in­dus­try groups and the gov­ern­ment. Us­ing five years of FDA data, re­searchers ex­am­ined all high-risk med­i­cal de­vice re­calls to de­ter­mine what level of ap­proval process had been used for clear­ance. Ac­cord­ing to the study, which ap­peared on­line Feb. 14 in the Ar­chives of In­ter­nal Medicine, 71% of the 113 high-risk re­calls that took place from 2005 to 2009 had gone through the agency’s ex­pe­dited re­view process, known as 510(k), while only 19% had gone through the more strin­gent pre­mar­ket ap­proval process in­volv­ing clin­i­cal tri­als.

The study was pub­lished a week af­ter the FDA took a new step to ease the ap­proval process for med­i­cal de­vices. The ini­tia­tive, called the In­no­va­tion Path­way, would speed the clear­ance process for cer­tain de­vices, a move the FDA says will spur de­vel­op­ment and help pa­tients get the care they need.

Those pri­or­i­ties were the sub­ject of a Feb. 17 House sub­com­mit­tee hear­ing fo­cused on the im­pact of med­i­cal de­vice reg­u­la­tion on the econ­omy and on pa­tients, an event at­tended by au­thors of the study.

“I have noth­ing against in­no­va­tion,” said lead au­thor Diana Zuck­er­man, pres­i­dent of the not-for-profit Na­tional Re­search Cen­ter for Women & Fam­i­lies. “But we hear from pa­tients who chose a top hos­pi­tal and a great doc­tor and ended up with a de­vice that has never been tested.”

Cre­ated in 1976, when the FDA was given reg­u­la­tory au­thor­ity over med­i­cal de­vices, the 510(k) pro­gram was con­ceived as a way to pro­vide a faster, eas­ier path to ap­proval for de­vices that were sim­i­lar to oth­ers al­ready on the mar­ket.

Zuck­er­man says the orig­i­nal in­tent of the 510(k) des­ig­na­tion has been stretched far be­yond what it was orig­i­nally in­tended to ad­dress.

“The idea made sense then, but the un­der­stand­ing was that the pro­vi­sion would fade away be­cause de­vices would be less and less sim­i­lar to each other,” Zuck­er­man said. “But it went in the op­po­site direc­tion. In­stead of mak­ing sure high-risk de­vices were held to a higher stan­dard, soon prac­ti­cally noth­ing was be­ing held to that higher stan­dard.”

Nearly a third of the re­calls dur­ing the five-year pe­riod were car­dio­vas­cu­lar de­vices and 23 of those had been cleared through the 510(k) process, the study found. Also, 13 of those 510(k) de­vices—many of which were ex­ter­nal car­diac de­fib­ril­la­tors used to re­sus­ci­tate pa­tients in dis­tress—were des­ig­nated as class III de­vices, a clas­si­fi­ca­tion that man­dates clear­ance through the more rig­or­ous pre­mar­ket ap­proval process, Zuck­er­man said.

“High-risk re­calls are de­fined by the FDA as hav­ing the po­ten­tial to cause death or se­ri­ous in­jury,” she said. “Since the de­vices that go through 510(k) process are sup­posed to be low or mod­er­ate risk, there shouldn’t be any high-risk re­calls in that group.”

Not so fast, said of­fi­cials from the Ad­vanced Med­i­cal Tech­nol­ogy As­so­ci­a­tion, or Ad­vaMed, a med­i­cal de­vice in­dus­try group. They called the pa­per “fun­da­men­tally flawed,” ar­gu­ing the FDA has an ex­cel­lent record of safety. They also said the re­view process needs to be shorter— not longer—to sup­port in­no­va­tion and com­pet­i­tive­ness.

In a state­ment, Stephen Ubl, Ad­vaMed’s pres­i­dent and CEO, said Zuck­er­man’s re­search con­tained faulty anal­y­sis. He con­trasted it with three pre­vi­ous stud­ies, all of which used the same data set and found the 510(k) process to be safe.

Zuck­er­man re­sponded by point­ing to pre­vi­ous stud­ies’ au­thors ties to in­dus­try and by not­ing that her study and the oth­ers con­tained sim­i­lar analy­ses.

“The bot­tom line is that these three stud­ies all agree that only a small per­cent­age of de­vices cleared through the 510(k) process are re­called,” she said. “We agree with that. But we dis­agree with any con­clu­sions by Ad­vaMed or in­dus­try con­sul­tants that this means the 510(k) process shouldn’t be im­proved.”

One of main flaws in Zuck­er­man’s study, ac­cord­ing to David Nexon, Ad­vaMed’s se­nior ex­ec­u­tive vice pres­i­dent, is that it equates a se­ri­ous re­call with a high-risk de­vice.

“One re­called prod­uct was a teething ring, and there was a ster­il­iza­tion is­sue with one of the lots,” Nexon said. “You want to strive for zero events, but surely no one would think a teething ring should be sub­ject to a clin­i­cal trial.”

Ex­pand­ing the pre­mar­ket ap­proval process would have a dev­as­tat­ing ef­fect on in­no­va­tion, Nexon coun­tered, be­cause that process takes much more time and money.

If a prod­uct re­quires pre­mar­ket ap­proval, it should get it, he said. But if sim­i­lar prod­ucts have been shown to work safely, 510(k) is the way to go.

The FDA also fired back at Zuck­er­man’s anal­y­sis in its own state­ment, say­ing the 80 re­calls, while trou­bling, still rep­re­sented a very small per­cent­age of the more than 19,000 de­vices cleared through the 510(k) process be­tween 2005 and 2009. In ad­di­tion, the agency said, 13 of those 80 de­vices are al­ready be­ing con­sid­ered for re­clas­si­fi­ca­tion.

The FDA also high­lighted its re­cent ex­ter­nal de­fib­ril­la­tor ini­tia­tive, an ef­fort the agency said will in­volve con­sid­er­a­tion for re­clas­si­fi­ca­tion.

Of­fi­cials said the num­ber of re­called 510(k) cases was a prod­uct of prob­a­bil­ity.

“More than 90% of the de­vices (that re­quire pre­mar­ket re­view) are cleared via the 510(k) path­way,” ac­cord­ing to the FDA. “It’s not sur­pris­ing that the ma­jor­ity of de­vices are 510(k).”

The agency has taken some steps to ad­dress crit­i­cism of its ex­pe­dited re­view process. In Au­gust 2010, the FDA’s 510(k) Work­ing Group re­leased a pre­lim­i­nary re­port out­lin­ing sug­gested changes such as in­creased use of clin­i­cal tri­als.

But when the FDA re­leased its fi­nal, 25-item ac­tion plan in Jan­uary, the agency had es­chewed many of the pa­tient-safety-driven changes in fa­vor of in­dus­try-fa­vored changes such as more stream­lined re­view, Zuck­er­man said.

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