Stephen Hahn, FDA commissioner (AP Images)

FDA touts ad­vanced man­u­fac­tur­ing to ad­dress Covid-19 short­falls

Anand Shah

Ad­vanced man­u­fac­tur­ing tech­niques can be em­ployed to help ad­dress some of the man­u­fac­tur­ing and sup­ply chain prob­lems the US has seen dur­ing the Covid-19 pan­dem­ic, Stephen Hahn, FDA com­mis­sion­er, and Anand Shah, FDA deputy com­mis­sion­er for med­ical and sci­en­tif­ic af­fairs, wrote in a blog post on the FDA web­site.

“The po­ten­tial pub­lic health val­ue of ad­vanced man­u­fac­tur­ing is even greater in the con­text of the on­go­ing COVID-19 pan­dem­ic, which has high­light­ed the strain on sup­ply chains and the need for adap­tive man­u­fac­tur­ing sys­tems to ac­cel­er­ate the pro­duc­tion of med­ical coun­ter­mea­sures,” Hahn and Shah wrote. “The FDA has es­tab­lished a strong reg­u­la­to­ry foun­da­tion to sup­port the up­take of ad­vanced man­u­fac­tur­ing, and COVID-19 pro­vides the unique im­pe­tus to spur fur­ther ad­vance­ment of med­ical man­u­fac­tur­ing.”

They high­light­ed key reg­u­la­tions the agency has pro­mul­gat­ed in re­cent years to sup­port ad­vanced man­u­fac­tur­ing, specif­i­cal­ly:

  • The Emerg­ing Tech­nol­o­gy Pro­gram un­der the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER), which sup­ports com­pa­nies in de­vel­op­ing process con­trol mea­sures for con­tin­u­ous man­u­fac­tur­ing of drugs be­fore sub­mis­sion.
  • The Ad­vanced Tech­nolo­gies Team un­der the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER) which sup­ports de­vel­op­ers by ad­dress­ing tech­ni­cal con­sid­er­a­tions need­ed to cre­ate gene ther­a­pies.
  • The de­vel­op­ment of “leapfrog” guid­ance doc­u­ments to share the agency’s think­ing on emerg­ing tech­nolo­gies that could be im­por­tant in pub­lic health emer­gen­cies. Such an­tic­i­pa­to­ry guid­ance sup­ports in­no­va­tors as they bring new tech­nolo­gies to health care.
  • Part­ner­ships and re­search to ex­pand knowl­edge sur­round­ing ad­vanced man­u­fac­tur­ing.

Ad­di­tion­al ef­forts have been un­der­tak­en dur­ing the cur­rent pub­lic health emer­gency, Hahn and Shah point­ed out. A mul­ti­year ef­fort be­tween CDER and the US Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA) is look­ing at how con­tin­u­ous man­u­fac­tur­ing process­es can sup­port the pro­duc­tion of med­ical coun­ter­mea­sures. Fur­ther, the FDA Of­fice of the Chief Sci­en­tist (OCS) and the Cen­ter for De­vices and Ra­di­o­log­i­cal Health (CDRH) are work­ing with the Na­tion­al In­sti­tutes of Health and the De­part­ments of Vet­er­ans Af­fairs to share in­for­ma­tion on 3D print­ing stan­dards to in­crease the stock of es­sen­tial med­ical sup­plies in­clud­ing per­son­al pro­tec­tive equip­ment and cer­tain med­ical de­vice parts.

FDA al­so is work­ing with­in the In­ter­na­tion­al Coun­cil for Har­mo­niza­tion to make sure that con­tin­u­ous man­u­fac­tur­ing guid­ances are aligned in­ter­na­tion­al­ly to sup­port in­no­va­tors, Hahn and Shah wrote.

“Be­cause pan­demics by na­ture are un­pre­dictable, our ap­proach to man­u­fac­tur­ing must be adapt­able. Ad­vanced man­u­fac­tur­ing pro­vides an ap­proach for pro­tect­ing our sup­ply chain and im­prov­ing our re­sponse ca­pac­i­ty dur­ing cri­sis sit­u­a­tions,” they con­clud­ed. “By es­tab­lish­ing the reg­u­la­to­ry foun­da­tion, the FDA has cre­at­ed a path­way for in­dus­try to con­tin­ue adopt­ing the need­ed im­prove­ments in man­u­fac­tur­ing tech­nol­o­gy for the ben­e­fit of pub­lic health.”

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