Stephen Hahn (AP Images)

Hahn tes­ti­fies on Covid-19 re­sponse, says FDA on tar­get to hit user fee goals

FDA com­mis­sion­er Stephen Hahn on Tues­day tes­ti­fied be­fore the House En­er­gy and Com­merce Com­mit­tee on his agency’s re­sponse to the coro­n­avirus dis­ease (Covid-19) pan­dem­ic.

User fee goals, pol­i­cy re­view

De­spite an “in­cred­i­ble surge in vol­ume” of ap­pli­ca­tions and con­straints on the agency’s abil­i­ty to con­duct in­spec­tions, Hahn said that the FDA “has main­tained the same pace of meet­ing its goals on ap­pli­ca­tions for med­ical prod­ucts for the last six months that is has main­tained in re­cent years.”

“We are on tar­get to meet our user fee goals for drugs this year by tak­ing ac­tion on at least 90% of brand, gener­ic and biosim­i­lar drug ap­pli­ca­tions, even dur­ing the pan­dem­ic,” Hahn said.

De­spite Hahn’s as­sur­ances, the FDA has ac­knowl­edged the pos­si­bil­i­ty that it will miss some of its user fee pro­gram goals in its re­cent guid­ance on for­mal meet­ings and ap­pli­ca­tions.

Hahn al­so re­it­er­at­ed that the FDA is re­view­ing its re­sponse to the pan­dem­ic, “To iden­ti­fy and ad­dress po­ten­tial or­ga­ni­za­tion­al and pro­gram­mat­ic changes that should be im­ple­ment­ed with­out de­lay.”

“A ma­jor fo­cus of this ef­fort will be to iden­ti­fy what reg­u­la­to­ry poli­cies should be con­tin­ued and ac­cel­er­at­ed,” Hahn said, re­fer­ring to Ex­ec­u­tive Or­der 13924, which in­structs fed­er­al agen­cies to ex­tend reg­u­la­to­ry flex­i­bil­i­ties grant­ed amid the pan­dem­ic to pro­mote eco­nom­ic re­cov­ery.

Re­spond­ing to a ques­tion from Rank­ing Mem­ber Greg Walden (R-OR) on where agen­cies could use ad­di­tion­al fund­ing, Hahn said that the FDA needs to im­prove its abil­i­ty to gath­er and use re­al world ev­i­dence, es­pe­cial­ly in a rapid­ly evolv­ing pub­lic health emer­gency.

“We have learned that we need to col­lect re­al world ev­i­dence in re­al-time dur­ing an emer­gency  … to in­form de­ci­sions and how we could change them mov­ing for­ward, so your sup­port for re­al world ev­i­dence gen­er­a­tion would be in­cred­i­bly help­ful,” Hahn said.

De­vel­op­ment, ap­provals and test­ing

Hahn told mem­bers of the com­mit­tee he could not give a time­line for the ap­proval or emer­gency use au­tho­riza­tion (EUA) of a vac­cine or ad­di­tion­al ther­a­peu­tics for COVID-19, but em­pha­sized that “da­ta and sci­ence will dic­tate” when that hap­pens. He added that the FDA will use every au­thor­i­ty and reg­u­la­to­ry flex­i­bil­i­ty at its dis­pos­al to ap­prove prod­ucts once da­ta is avail­able.

On whether a vac­cine could be au­tho­rized un­der an EUA, An­tho­ny Fau­ci, di­rec­tor of the Na­tion­al In­sti­tute for Al­ler­gy and In­fec­tious Dis­eases, said he “would be very dis­ap­point­ed if we jumped to a con­clu­sion be­fore we knew that a vac­cine was tru­ly safe and tru­ly ef­fec­tive be­cause I wouldn’t want the per­pet­u­al am­bi­gu­i­ty of not know­ing whether or not it is tru­ly safe and tru­ly ef­fec­tive.”

Hahn added that the FDA is work­ing to ac­cel­er­ate the de­vel­op­ment of vac­cines by pro­vid­ing tech­ni­cal as­sis­tance on clin­i­cal tri­al de­sign and end­points to spon­sors, but said much of the ac­cel­er­a­tion will come from “tak­ing fi­nan­cial risk around the de­vel­op­ment process … not cut­ting cor­ners with re­spect to the as­sess­ment of safe­ty and ef­fec­tive­ness.”

As for an EUA or ap­proval for a vac­cine, “I can­not pre­judge when that will hap­pen,” Hahn said.

Lat­er in the hear­ing, Rep. Deb­bie Din­gell (D-MI) asked Hahn to com­mit to re­ceiv­ing da­ta from Phase III stud­ies be­fore ap­prov­ing a vac­cine for COVID-19, cit­ing con­cerns over safe­ty if tri­als are rushed or un­der­pow­ered.

“We are work­ing on, right now, guid­ance for spon­sors and de­vel­op­ers of vac­cines to ex­act­ly ad­dress the ques­tion that you’re ask­ing,” Hahn said, and as­sured Din­gell that the FDA would wait for the da­ta it needs to make a de­ter­mi­na­tion about safe­ty and ef­fi­ca­cy.

Sim­i­lar­ly, Hahn said he can­not es­ti­mate when the agency might is­sue EUAs for ad­di­tion­al ther­a­peu­tics, af­ter its EUAs for hy­drox­y­chloro­quine/chloro­quine and remde­sivir.

“I an­tic­i­pate that we will re­ceive da­ta re­gard­ing sev­er­al ther­a­pies in the fu­ture, [con­va­les­cent] plas­ma be­ing one of them … po­ten­tial­ly al­so with some an­ti-in­flam­ma­to­ry agents, as well as mon­o­clon­al an­ti­bod­ies,” Hahn said.

Hahn not­ed that the FDA now has safe­ty da­ta from more than 20,000 pa­tients who re­ceived con­va­les­cent plas­ma un­der an ex­pand­ed ac­cess treat­ment pro­to­col and that the agency’s pre­lim­i­nary as­sess­ment of the ther­a­py’s ef­fi­ca­cy is “quite en­cour­ag­ing.”

In re­sponse to ques­tion­ing from Rep. An­na Es­hoo (D-CA) on re­ports of po­lit­i­cal in­ter­fer­ence in the agency’s de­ci­sion mak­ing around hy­drox­y­chloro­quine, Hahn com­mit­ted to re­port any per­ceived po­lit­i­cal pres­sure to the com­mit­tee and stat­ed, “I have not felt po­lit­i­cal pres­sure nor has the FDA to make any de­ci­sion in any spe­cif­ic di­rec­tion.”

Re­spond­ing to ques­tions about Pres­i­dent Don­ald Trump’s re­cent state­ments about di­rect­ing of­fi­cials to slow down coro­n­avirus test­ing in the US, Hahn, Fau­ci and Cen­ter for Dis­ease Con­trol and Pre­ven­tion Di­rec­tor Robert Red­field all de­nied be­ing in­struct­ed to im­pede test­ing ef­forts.

“None of us have ever been told to slow down on test­ing, that just is a fact,” Fau­ci said. Fau­ci and the oth­er ad­min­is­tra­tion of­fi­cials agreed that more test­ing is nec­es­sary to com­bat the out­break.

Red­field al­so not­ed that the CDC re­quest­ed an EUA for a com­bined Covid-19 and in­fluen­za test last week, which he said will be use­ful when the flu sea­son be­gins in the fall.

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