FDA to roll out mod­ern­iza­tion plan in push for da­ta in­ter­op­er­abil­i­ty

Amy Aber­nethy FDA

An ac­tion plan will be rolled out in the com­ing months to de­fine the FDA’s ap­proach to mod­ern­iz­ing its tech­nol­o­gy in­fra­struc­ture and frame­work, FDA Prin­ci­pal Deputy Com­mis­sion­er Amy Aber­nethy said dur­ing a Thurs­day keynote at the Of­fice of the Na­tion­al Co­or­di­na­tor for Health In­for­ma­tion Tech­nol­o­gy’s (ONC) 3rd in­ter­op­er­abil­i­ty fo­rum.

FDA mod­ern­iza­tion ef­forts have been un­der­way in re­cent years, with the re­or­ga­ni­za­tions of the Cen­ter for De­vices and Ra­di­o­log­i­cal Health and the Cen­ter for Drug Eval­u­a­tion and Re­search. The plan that the FDA in­tends to roll out soon is a cross-cen­ter ap­proach.

Aber­nethy said that the FDA’s plan con­tains an agency-wide ob­jec­tive—ad­vanc­ing in­ter­op­er­abil­i­ty to in­form reg­u­la­to­ry de­ci­sion-mak­ing in re­al-time. This, in turn, is in­tend­ed to ex­pe­dite de­ter­mi­na­tions on sub­mis­sions and im­prove reg­u­la­to­ry over­sight to in­crease pa­tient ac­cess to med­ical prod­ucts deemed to be safe and ef­fec­tive at a faster pace, as well as to en­able ear­li­er prod­uct in­ter­ven­tions in the post-mar­ket set­ting.

Crit­i­cal­ly eval­u­at­ing in­ter­op­er­a­ble tech­nolo­gies, match­ing the best so­lu­tions to the char­ac­ter­is­tics of a pa­tient at the point of care and en­sur­ing that da­ta are “avail­able, re­li­able and well-char­ac­ter­ized” are the next steps in the jour­ney to­ward in­ter­op­er­abil­i­ty, said Aber­nethy. As such, the fo­cus of the plan is cen­tered on mod­ern­iz­ing the FDA’s tech in­fra­struc­ture and frame­work and pro­mot­ing in­ter­op­er­abil­i­ty use cas­es.

Aber­nethy not­ed the agency’s vi­sion for in­ter­op­er­abil­i­ty with­in the con­text of re­al-world ev­i­dence. This seeks to make use of ap­pli­ca­tion pro­gram­ming in­ter­faces to cre­ate ef­fi­cien­cies around reg­u­la­to­ry re­view process­es and track med­ical prod­ucts through­out their life­cy­cle by lever­ag­ing da­ta sources like elec­tron­ic health records (EHRs) to cre­ate a to­tal­i­ty of ev­i­dence that bet­ter in­forms ben­e­fit-risk pro­files.

The agency is “tak­ing a thought­ful and proac­tive ap­proach to help ad­vance” the in­ter­op­er­abil­i­ty sto­ry part­ly via “ap­pro­pri­ate and fit to scale use of tech­nol­o­gy with­in a mod­ern­ized re­view in­fra­struc­ture,” as well as “build­ing and en­sur­ing that tech­nol­o­gy is in place at a mod­ern FDA,” said Aber­nethy. “We are build­ing a dy­nam­ic reg­u­la­to­ry en­vi­ron­ment across the en­tire cy­cle of prod­uct de­vel­op­ment to help us meet the pace of med­ical in­no­va­tion.”

As part of the work to up­date how the agency in­ter­faces with the stake­hold­er com­mu­ni­ty, the plan will look to bet­ter en­gage with the tech com­mu­ni­ty. “We need to de­fine the in­ter­faces so that there is a core un­der­stand­ing” of how in­for­ma­tion can be passed in­to FDA “as ef­fi­cient­ly as pos­si­ble,” she added.

Aber­nethy al­so point­ed to “a world where FDA and ONC are work­ing to­geth­er as sis­ter agen­cies to pro­vide an ac­tu­al roadmap” of how da­ta sets can be gen­er­at­ed as well as pres­sure test­ing “what hap­pens when a da­ta el­e­ment tra­vers­es from the EHR all the way through the process in­to clin­i­cal re­search.” She not­ed the po­ten­tial of an en­vi­sioned project she calls “the life of a da­ta el­e­ment,” to chart a path that helps the FDA iden­ti­fy ar­eas where it should pro­vide guid­ance to spon­sors and EHR ven­dors.

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

So­cial im­age: Amy Aber­nethy, World Med­ical In­no­va­tion Fo­rum via Youtube


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Doug Throckmorton speaks via video conference to the Senate Finance Committee, June 2, 2020 (Andrew Caballero-Reynolds, AP Images)

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