Ned Sharpless. NCI

Sharp­less out­lines FDA’s key pri­or­i­ties for ad­vanc­ing pub­lic health

Four months in­to his tenure, Act­ing FDA Com­mis­sion­er Ned Sharp­less sent an email to FDA staff on Tues­day out­lin­ing four main pri­or­i­ty ar­eas: as­sur­ing pub­lic health through emerg­ing tech­nolo­gies, in­vest­ing in the FDA’s next gen­er­a­tion ex­pert work­force and in­fra­struc­ture, mod­ern­iz­ing frame­works and pro­mot­ing and pro­tect­ing con­sumer and pa­tient safe­ty.

On the emerg­ing tech­nolo­gies front, Sharp­less dis­cussed how the FDA is try­ing to stay ahead of the curve while en­cour­ag­ing in­dus­try to adopt less cost­ly and more re­li­able ad­vanced man­u­fac­tur­ing plat­forms.

“We see the promise of tech­nolo­gies like 3D-print­ed de­vices, cell-cul­tured food, cell-based ther­a­peu­tics, and in­ten­tion­al ge­nom­ic al­ter­ations to an­i­mals and plants to de­liv­er enor­mous ben­e­fits to pub­lic health. As these fas­ci­nat­ing tech­nolo­gies are de­vel­oped, how­ev­er, the FDA will al­so need to aug­ment its ex­per­tise in these ar­eas to af­ford op­ti­mal re­view and reg­u­la­tion of prod­ucts de­rived from cut­ting-edge tech­nol­o­gy,” he wrote.

Sharp­less al­so de­clared hir­ing as an “im­me­di­ate pri­or­i­ty,” as oth­er of­fi­cials have lament­ed the gaps in the FDA’s work­force.

“We will be de­ploy­ing the 21st Cen­tu­ry Cures hir­ing au­thor­i­ty at much greater scale. Sim­ply put, we need to re­cruit, de­vel­op, and re­tain world- class peo­ple, and will be an­nounc­ing more spe­cif­ic plans in these ar­eas soon,” he wrote.

On mod­ern­iz­ing frame­works, Sharp­less touched on the FDA’s work to speed gener­ic drugs and biosim­i­lars to mar­ket to low­er drug prices and not­ed work to try to help in­dus­try with “the most ex­pen­sive part of drug dis­cov­ery and de­vel­op­ment,” which is the clin­i­cal test­ing.

“To ex­pe­dite de­vel­op­ment of ef­fec­tive ther­a­peu­tics and di­ag­nos­tics, we will con­tin­ue to pro­mote the use of in­no­v­a­tive clin­i­cal tri­al de­signs such as plat­form tri­als, bas­ket stud­ies, adap­tive tri­als, and prag­mat­ic ran­dom­ized con­trolled tri­als that are more ef­fi­cient and will low­er costs of run­ning tri­als,” he wrote.

Re­al-world ev­i­dence, a top­ic dis­cussed last week at an FDA event, will al­so help with pre- and post­mar­ket ad­verse event de­tec­tion and ef­fi­ca­cy analy­ses for clin­i­cal sit­u­a­tions where ran­dom­ized clin­i­cal tri­als may not be fea­si­ble.

“En­hanced use of re­al-world ev­i­dence for reg­u­la­to­ry de­ci­sion mak­ing will im­prove the gen­er­al­iz­abil­i­ty of ev­i­dence to pa­tient pop­u­la­tions that may be ex­clud­ed from tra­di­tion­al clin­i­cal tri­als,” he added.

As far as pa­tient safe­ty, Sharp­less re­it­er­at­ed the FDA’s in­ter­est in strength­en­ing post-mar­ket sur­veil­lance.

“For in­stance, nov­el ma­chine learn­ing al­go­rithms can al­low us to pri­or­i­tize in­ter­na­tion­al mail in­spec­tions to bet­ter de­tect il­lic­it opi­oid ship­ments; blockchain can help us track and trace food out­breaks with greater speed; and aug­ment­ed track and trace tech­nolo­gies can help us im­prove the safe­ty of drugs, de­vices, and vet­eri­nary prod­ucts,” he wrote.

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.


Zachary Brennan

managing editor, RAPS

Brian Kaspar. AveXis via Twitter

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

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