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.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

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