White House dou­bles down on call to fund FDA en­tire­ly with in­dus­try fees

WASH­ING­TON, DC — Fol­low­ing the House of Rep­re­sen­ta­tives’ pas­sage of the bill to reau­tho­rize FDA user fees on Wednes­day, the White House dou­bled down on its ear­li­er call to amend the agree­ments so that FDA is en­tire­ly fund­ed by med­ical prod­ucts in­dus­tries.

“The Ad­min­is­tra­tion urges the Con­gress to pro­vide for 100 per­cent user fee fund­ing with­in the reau­tho­rized pro­grams,” the White House said in a state­ment. “In an era of re­newed fis­cal re­straint, in­dus­tries that ben­e­fit di­rect­ly from FDA’s work should pay for it.”

In May, Pres­i­dent Don­ald Trump re­leased his bud­get pro­pos­al, which was the first time the Ad­min­is­tra­tion called to elim­i­nate all ap­pro­pri­a­tions for FDA and fund the agency en­tire­ly with in­dus­try fees.

Wednes­day’s state­ment al­so says the Trump Ad­min­is­tra­tion is “con­cerned with cer­tain oth­er pro­vi­sions in the bill, such as those pro­vid­ing ad­di­tion­al mar­ket ex­clu­siv­i­ty to man­u­fac­tur­ers, which could make ex­clu­siv­i­ty un­pre­dictable and de­crease com­pe­ti­tion.”

Sec­tion 703 of the bill is cur­rent­ly the on­ly one that ad­dress­es mar­ket ex­clu­siv­i­ty, but it “pro­vides a pe­ri­od of 180-day mar­ket ex­clu­siv­i­ty to cer­tain gener­ic drug man­u­fac­tur­ers that en­ter the mar­ket where there is cur­rent­ly no block­ing patents or ex­clu­siv­i­ties, in­cen­tiviz­ing gener­ic drug man­u­fac­tur­ers to com­pete with off-patent drugs.”

In short: that sec­tion aims to in­crease com­pe­ti­tion and low­er costs by in­cen­tiviz­ing the de­vel­op­ment of new gener­ic drugs for which brand name ref­er­ence prod­ucts have a mo­nop­oly.

The Ad­min­is­tra­tion’s pre­vi­ous com­ments to de­rail the user fee agree­ments were not well re­ceived by mem­bers of Con­gress on ei­ther side of the aisle.

At both House and Sen­ate com­mit­tee hear­ings on the bill there was bi­par­ti­san agree­ment that FDA should not be en­tire­ly fund­ed by in­dus­try fees and that the agree­ments forged over the last two years be­tween in­dus­try and FDA should be what is in­clud­ed in the reau­tho­riza­tion.

But some on the Sen­ate side are still push­ing for add-ons in the eleventh hour.

Brit­tni Palke, press sec­re­tary for Sen. Ron John­son (R-WI), con­firmed to Fo­cus on Thurs­day that the sen­a­tor “plans to hold up the FDA bill un­less it con­tains Right to Try leg­is­la­tion,” which is al­so sup­port­ed by Pres­i­dent Trump.

Sec­tion-by-Sec­tion Analy­sis of House Bill

Al­so on Wednes­day, the House re­leased its full re­port on the FDA Reau­tho­riza­tion Act of 2017, of­fer­ing a break­down of what each sec­tion of the bill would do. Here’s a re­cap of some of the sec­tion sum­maries with sig­nif­i­cant changes from years past, cat­e­go­rized by the type of med­ical prod­uct.

De­vices

Sec­tion 202 adds the term “de no­vo clas­si­fi­ca­tion re­quest” to en­able new user fees to be col­lect­ed by FDA to specif­i­cal­ly re­view de no­vo med­ical de­vice clas­si­fi­ca­tion re­quests.

Sec­tion 205 es­tab­lish­es a pi­lot pro­gram, to sun­set in 2022, to pro­vide FDA with the au­thor­i­ty to au­dit and cer­ti­fy lab­o­ra­to­ries that con­duct de­vice con­for­mance test­ing to a rec­og­nized stan­dard, and al­so to with­draw the cer­ti­fi­ca­tion if nec­es­sary. FDA is re­quired to eval­u­ate the use of this scheme in at least five de­vice types, or de­vice parts that are found in mul­ti­ple de­vices, and the agency is al­so re­quired to ob­tain pub­lic in­put on the pi­lot’s de­vel­op­ment.

Sec­tion 206 reau­tho­rizes and pro­vides flex­i­bil­i­ty to bet­ter tar­get which de­vice types are most ap­pro­pri­ate for third-par­ty re­view. The sec­tion al­so re­quires a pub­lic guid­ance de­vel­op­ment process to iden­ti­fy the fac­tors to de­ter­mine which de­vices are el­i­gi­ble.

Sec­tion 207 re­quires all de­vice sub­mis­sions to be in elec­tron­ic for­mat by 1 Oc­to­ber 2021, though that date can be ex­tend­ed to as late as 1 April 2023.

Sec­tion 601 re­quires FDA to in­spect med­ical de­vice es­tab­lish­ments us­ing a risk-based in­spec­tion sched­ule.

Sec­tion 603 es­tab­lish­es stan­dards to im­prove pre­dictabil­i­ty for sched­uled (not for-cause) in­spec­tions for med­ical de­vice fa­cil­i­ties.

Sec­tion 604 clar­i­fies the process for the is­suance of for­eign ex­port cer­tifi­cates for de­vices and es­tab­lish­es a path­way by which man­u­fac­tur­ers de­nied a cer­tifi­cate can present in­for­ma­tion and work with FDA to cor­rect out­stand­ing is­sues.

Sec­tion 613 re­quires FDA to pro­mul­gate reg­u­la­tions to es­tab­lish a cat­e­go­ry of over-the-counter hear­ing aids. “In do­ing so, FDA should con­sult with rel­e­vant stake­hold­ers, in­clud­ing hear­ing aid man­u­fac­tur­ers, li­censed hear­ing pro­fes­sion­als, pa­tients, and oth­ers, dur­ing the rule­mak­ing process,” the sum­ma­ry says.

Sec­tion 614 re­quires FDA to is­sue a re­port on how the agency in­tends to en­sure the qual­i­ty, safe­ty and ef­fec­tive­ness of de­vices that have been ser­viced, as well as whether FDA’s cur­rent au­thor­i­ty is suf­fi­cient to over­see and reg­u­late ser­vic­ing or whether ad­di­tion­al au­thor­i­ty is nec­es­sary.

Sec­tion 615 cre­ates a new vol­un­tary pi­lot pro­gram for de­vice man­u­fac­tur­ers who wish to meet FDA re­port­ing or post­mar­ket study re­quire­ments us­ing ac­tive sur­veil­lance.

Sec­tion 616 clar­i­fies a process by which FDA clas­si­fies med­ical de­vice ac­ces­sories based on the in­tend­ed use of the ac­ces­so­ry.

Sec­tion 801 al­lows FDA to ap­prove an imag­ing de­vice “with the use of a con­trast agent as long as the con­trast agent is used at the same dose, in the same pa­tient pop­u­la­tion, with the same type of imag­ing tech­nol­o­gy, and does not pose any ad­di­tion­al safe­ty risk.”

Sec­tion 802 clar­i­fies that a con­trast agent for which an ap­pli­ca­tion has been ap­proved may be ap­proved for a new in­di­ca­tion or con­di­tion fol­low­ing the au­tho­riza­tion of a pre­mar­ket sub­mis­sion for an ap­plic­a­ble med­ical imag­ing de­vice for that use.

Gener­ics

Sec­tion 303 up­dates the gener­ic drug user fee struc­ture to pro­vide more pre­dictabil­i­ty for FDA and flex­i­bil­i­ty for small busi­ness­es. The sec­tion re­moves the fees for pri­or ap­proval sup­ple­ments and es­tab­lish­es a gener­ic drug ap­pli­cant pro­gram fee.

Sec­tion 701 re­quires FDA to ex­pe­dite the re­view and de­vel­op­ment of gener­ic drugs if there is not more than one ap­proved ver­sion of the drug ac­tive­ly be­ing mar­ket­ed.

Sec­tion 702 im­proves com­mu­ni­ca­tion be­tween FDA and gener­ic drug ap­pli­ca­tion spon­sors about the cat­e­gor­i­cal sta­tus of their ap­pli­ca­tions.

Sec­tion 703 pro­vides a pe­ri­od of 180-day mar­ket ex­clu­siv­i­ty to cer­tain gener­ic drug man­u­fac­tur­ers that en­ter the mar­ket where there is cur­rent­ly no block­ing patents or ex­clu­siv­i­ties, in­cen­tiviz­ing gener­ic drug man­u­fac­tur­ers to com­pete with off-patent drugs.

Sec­tion 705 di­rects the Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO) to is­sue a re­port on the rate of gener­ic drug ap­pli­ca­tions that are ap­proved on the first re­view cy­cle and re­lat­ed is­sues.

Biosim­i­lars

Sec­tion 403 es­tab­lish­es an in­de­pen­dent fee struc­ture for biosim­i­lars for the first time based on an “Ini­tial Biosim­i­lar De­vel­op­ment Fee,” an “An­nu­al Biosim­i­lar De­vel­op­ment Fee,” a “Biosim­i­lar Pro­gram Fee” for spon­sors of ap­proved biosim­i­lars and an ap­pli­ca­tion fee.

Pre­scrip­tion Drugs, Pri­or­i­ty Re­view Vouch­ers and Oth­er Pro­vi­sions

Sec­tion 504 “rais­es the penal­ties for know­ing­ly mak­ing, sell­ing or dis­pens­ing, or hold­ing for sale or dis­pens­ing, a coun­ter­feit drug to con­form with the penal­ties for il­le­gal­ly di­vert­ing drugs.”

Sec­tion 505 “ex­press­es a Sense of Con­gress that the Sec­re­tary of HHS should com­mit to en­gag­ing with Con­gress on ad­min­is­tra­tive ac­tions and leg­isla­tive changes to low­er the cost of pre­scrip­tion drugs.”

Sec­tion 605 al­lows FDA to rec­og­nize au­di­tors used by for­eign gov­ern­ments to im­prove in­ter­na­tion­al har­mo­niza­tion of in­spec­tion stan­dards and in­crease FDA ac­cess to au­dit da­ta.

Sec­tion 704 clar­i­fies the qual­i­fy­ing cri­te­ria for com­pa­nies re­ceiv­ing a ne­glect­ed trop­i­cal dis­eases pri­or­i­ty re­view vouch­er to en­sure the PRV is award­ed to spon­sors that con­duct new clin­i­cal in­ves­ti­ga­tions nec­es­sary for FDA ap­proval.

Sec­tion 902 reau­tho­rizes the crit­i­cal path pub­lic-pri­vate part­ner­ship for an ad­di­tion­al five years at cur­rent law au­tho­riza­tion lev­els.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Im­age: Daniel Schwen

Author

Zachary Brennan

managing editor, RAPS

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