FDA ex­plains im­pact of Covid-19 on ap­pli­ca­tions, for­mal meet­ings

The FDA on Tues­day is­sued im­me­di­ate­ly ef­fec­tive guid­ance ex­plain­ing how the coro­n­avirus dis­ease pub­lic health emer­gency is im­pact­ing the con­duct of for­mal meet­ings and its re­view of cer­tain user fee-fund­ed ap­pli­ca­tions.

The guid­ance fea­tures 11 ques­tions and an­swers on how the agency in­tends to han­dle dis­rup­tions af­fect­ing meet­ings and goals un­der its user fee pro­grams es­tab­lished by the Pre­scrip­tion Drug User Fee Act (PDU­FA), Biosim­i­lar User Fee Act (BS­U­FA) and the Gener­ic Drug User Fee Amend­ments (GDU­FA).

Drug and bi­o­log­ics

FDA says its new drug and bi­o­log­ics pro­grams at the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) and Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER) are be­ing im­pact­ed by “con­sid­er­able in­creas­es in COVID-19 re­lat­ed work,” ne­ces­si­tat­ing shifts in re­sources and staff al­lo­ca­tion.

“With many staff mem­bers work­ing on COVID-19 ac­tiv­i­ties, it is pos­si­ble that we will not be able to sus­tain our cur­rent per­for­mance lev­el in meet­ing goal dates in­def­i­nite­ly,” FDA writes.

FDA says it will fo­cus its re­sources on ap­pli­ca­tions and sub­mis­sions re­lat­ed to Covid-19 and oth­er life-threat­en­ing con­di­tions and will “work di­rect­ly with the spon­sors and ap­pli­cants re­gard­ing their pend­ing ap­pli­ca­tions.”

FDA notes that it will still aim to con­duct ini­tial in­ves­ti­ga­tion­al new drug ap­pli­ca­tion (IND) 30-day safe­ty re­views and re­spond to “oth­er im­por­tant safe­ty is­sues that may emerge dur­ing IND de­vel­op­ment.”

FDA al­so ex­plains that it will com­mu­ni­cate di­rect­ly with spon­sors or ap­pli­cants if it an­tic­i­pates miss­ing a goal date, but notes that both the “PDU­FA and BS­U­FA goal let­ters do not con­tem­plate FDA ex­tend­ing or chang­ing user fee goal dates,” ex­cept in re­sponse to sub­mis­sion that would trig­ger a clock ex­ten­sion.

For­mal meet­ings

Dur­ing the pub­lic health emer­gency, FDA says that all meet­ings with in­dus­try will be held vir­tu­al­ly, via tele­con­fer­ence or video­con­fer­ence, not­ing that it has con­vert­ed many pre­vi­ous­ly sched­uled PDU­FA and BS­U­FA meet­ings from in-per­son to vir­tu­al at the same dates and times as orig­i­nal­ly sched­uled.

FDA says it is still ac­cept­ing new meet­ing re­quests “as per usu­al prac­tice,” but notes that it may pro­vide a writ­ten re­sponse on­ly in some cir­cum­stances and may reeval­u­ate the for­mat of some pend­ing meet­ings.

For ad­vi­so­ry com­mit­tee meet­ings, FDA says it is try­ing to fig­ure out whether meet­ings can be held vir­tu­al­ly on a case-by-case ba­sis.

“FDA is con­tin­u­ing to eval­u­ate the fea­si­bil­i­ty of con­duct­ing ad­vi­so­ry com­mit­tee meet­ings vir­tu­al­ly. We be­lieve we can host ad­vi­so­ry com­mit­tee meet­ings vir­tu­al­ly with cur­rent tech­nol­o­gy,” FDA says, but adds that it will dis­cuss the op­tion di­rect­ly with spon­sors and ap­pli­cants for spe­cif­ic ap­pli­ca­tions.

Gener­ic drugs

For the time be­ing, FDA says it is con­tin­u­ing its gener­ic drug pro­gram ap­pli­ca­tion as­sess­ment ac­tiv­i­ties but says that it “may need to shift re­sources to ad­dress ur­gent pub­lic health needs,” in re­sponse to short­ages.

How­ev­er, FDA in­structs gener­ic drug ap­pli­cants to con­tact the ap­pro­pri­ate project man­ag­er for their ap­pli­ca­tion if they “ex­pe­ri­ence a missed goal date.”

FDA notes that mid-re­view cy­cle meet­ings and post-com­plete re­sponse let­ter meet­ings are typ­i­cal­ly done via tele­con­fer­ence and adds up­com­ing face-to-face pre-ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA) meet­ings are be­ing con­vert­ed to tele­con­fer­ence. FDA says it will at­tempt to no­ti­fy ap­pli­cants at least four weeks in ad­vance of a meet­ing for­mat change.

FDA al­so says that it is pri­or­i­tiz­ing the re­view of AN­DAs ac­cord­ing to its re­cent­ly re­vised man­u­al of poli­cies and pro­ce­dures, which ex­plains that the agency will pri­or­i­tize AN­DAs for drugs that are in short­age, used to ad­dress the pub­lic health emer­gency or oth­er­wise meet the fac­tors for pri­or­i­ti­za­tion based on com­pe­ti­tion. FDA fur­ther ex­plains that it will con­sid­er “whether the AN­DA is for a drug be­ing in­ves­ti­gat­ed to treat or pre­vent Covid-19, but is not la­beled for this use, or for a drug be­ing used for its la­beled use to treat or pre­vent sec­ondary con­di­tions as­so­ci­at­ed with Covid-19.

In re­cent weeks FDA has an­nounced the ap­proval of sev­er­al AN­DAs for prod­ucts in short­age or sub­ject to in­creased de­mand amid the pub­lic health emer­gency, in­clud­ing hy­drox­y­chloro­quine sul­fate tablets, cisatracuri­um be­sy­late in­jec­tion, dexmedeto­mi­dine hy­drochlo­ride, suc­cinyl­choline chlo­ride in­jec­tion and azithromycin tablets.


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