Ar­gu­ments over med­i­cal-de­vice user fee re­flects FDA’S record

De­bate over de­vice user-fee act re­flects FDA’S record

Modern Healthcare - - NEWS - Jaimy Lee

The third reau­tho­riza­tion of the med­i­cal de­vice user-fee pro­gram is serv­ing as a re­minder of the Food and Drug Ad­min­is­tra­tion’s track record on safety and ef­fi­ciency over the past five years.

In the last year alone, the de­vice in­dus­try has ar­gued that the un­pre­dictabil­ity of de­vice-re­view path­ways has slowed in­no­va­tion in the U.S.; ad­vo­cacy groups have said that the agency is not pro­tect­ing pa­tients in some in­stances; and the In­sti­tute of Medicine rec­om­mended scrap­ping the FDA’S 510(k) re­view process, an ex­pe­dited re­view path­way used by nearly 90% of the de­vice sub­mis­sions re­ceived by the FDA.

The cur­rent Med­i­cal De­vice User Fee Act, which re­quires man­u­fac­tur­ers to pay user fees to the FDA in ex­change for agreed-upon per­for­mance goals, is set to ex­pire on Sept. 30.

Rep­re­sen­ta­tives of the de­vice in­dus­try, in­clud­ing the Ad­vanced Med­i­cal Tech­nol­ogy As­so­ci­a­tion, the Med­i­cal De­vice Man­u­fac­tur­ers As­so­ci­a­tion and the Med­i­cal Imag­ing & Tech­nol­ogy Al­liance, and the FDA missed a Jan­uary dead­line to sub­mit the user-fee rec­om­men­da­tions to Congress.

When an agree­ment in prin­ci­ple was reached the fol­low­ing month, the terms in­cluded dou­bling the user fees paid by in­dus­try to $595 mil­lion over the next five years, which would re­quire the FDA to hire more than 200 full-time em­ploy­ees, in­clud­ing 140 de­vice re­view­ers, and hire a third­party or­ga­ni­za­tion to au­dit the agency’s pre­mar­ket ap­proval re­view process.

“I am pleased to be able to re­port that af­ter ex­ten­sive ne­go­ti­a­tions, the user-fee agree­ment be­tween FDA and in­dus­try has been reached and is now await­ing your ac­tion,” said David Nexon, Ad­vamed’s se­nior ex­ec­u­tive vice pres­i­dent, in his tes­ti­mony dur­ing a Se­nate com­mit­tee hear­ing last week. “We be­lieve this agree­ment has the po­ten­tial to help achieve mean­ing­ful change in FDA per­for­mance through ground­break­ing ac­count­abil­ity and trans­parency mea­sures and en­hanced FDA re­sources.”

At the same hear­ing, Sen. Mike Enzi (RWyo.) de­scribed the ne­go­ti­a­tions as “con­tentious.”

How­ever, Janet Trunzo, Ad­vamed’s ex­ec­u­tive vice pres­i­dent of tech­nol­ogy and reg­u­la­tory af­fairs and the lead ne­go­tia­tor on the user-fee agree­ment, said Enzi was likely com­par­ing the de­vice user-fee ne­go­ti­a­tions with the drug pro­gram.

“We had a lot of changes to iden­tify,” she said. “It took us longer to reach agree­ment.”

The Of­fice of Man­age­ment and Bud­get signed off on the agree­ment last month and, fol­low­ing a public com­ment pe­riod that ends in mid-april, the rec­om­men­da­tions are ex­pected to be sent to Congress.

Sev­eral law­mak­ers expressed con­cern at the hear­ing about the lay­offs that would oc­cur if Congress does not ap­prove the agree­ment.

Lin­ger­ing con­cerns about the FDA’S per­for­mance goals un­der the cur­rent user-fee pro­gram led Sen. Richard Burr (R-N.C.) to re­quest that the Gov­ern­ment Ac­count­abil­ity Of­fice look at the is­sue.

At an­other hear­ing, House law­mak­ers ques­tioned why the agency’s user fees should be dou­bled if ap­proval times have in­creased.

The GAO re­port, which was re­leased last week, found that the time it takes for the FDA to is­sue final de­ci­sions has in­creased, for both the 510(k) and the more strin­gent pre-mar­ket ap­proval re­view path­ways.

It also re­ported that the agency in­con­sis­tently met per­for­mance goals for pre-mar­ket ap­proval sub­mis­sions.

“Ques­tions have been raised as to whether FDA is suf­fi­ciently meet­ing the per­for­mance goals and whether de­vices are reach­ing the mar­ket in a timely man­ner,” the GAO wrote.

Other or­ga­ni­za­tions say the in­dus­try isn’t pay­ing enough.

The Safe Pa­tient Project, an ini­tia­tive de­vel­oped by Con­sumers Union, is call­ing for stronger over­sight of med­i­cal de­vices, as well as an in­crease in the amount of user fees that the de­vice in­dus­try has agreed to pay.

“This money is re­ally needed to keep up with the in­dus­try’s growth,” said Lisa Mcgif­fert, di­rec­tor of the Safe Pa­tient Project. “We’re con­cerned it’s not ad­e­quate to fund what FDA needs in the next five years.”

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