FDA has about one month of user fee funds left, Got­tlieb warns

As the House preps to take ac­tion on in­di­vid­ual ap­pro­pri­a­tions bills this week, in­clud­ing one that will fund the FDA, Com­mis­sion­er Scott Got­tlieb has fur­ther clar­i­fied what the agency has left in user fee funds, what re­view ac­tiv­i­ties will take place and how the agency is help­ing its em­ploy­ees con­duct in­spec­tions.

Due to the par­tial shut­down, the FDA can­not ac­cept new 2019 user fees, which means the agency can­not ac­cept new med­ical prod­uct ap­pli­ca­tions un­less they are user-fee-pro­gram re­lat­ed but don’t re­quire the pay­ment of a user fee, which is “a very small sub­set of ap­pli­ca­tions,” Got­tlieb not­ed.

And though the FDA will con­tin­ue to work on ex­ist­ing ap­pli­ca­tions where user fees were paid pri­or to 22 De­cem­ber 2018, FDA can on­ly use user fee car­ry­over bal­ances from FY 2018, and Got­tlieb not­ed that among the med­ical prod­uct user fee pro­grams, the one that will run out of car­ry­over bal­ance first is like­ly the Pre­scrip­tion Drug User Fee Act (PDU­FA) funds, which are used for new drug re­views. “We have about one month of fund­ing left,” Got­tlieb said.

Got­tlieb has promised to re­lease fur­ther in­for­ma­tion on the ac­count bal­ances, burn rate and ap­prox­i­mate­ly how long ac­tiv­i­ties can con­tin­ue un­der car­ry­over bal­ances, ac­cord­ing to the non­prof­it Al­liance for a Stronger FDA’s shut­down toolk­it.

On the gener­ic drug end, dur­ing the par­tial shut­down, the FDA will not ac­cept gener­ic drug sub­mis­sions that re­quire pay­ment of a fee.

Got­tlieb clar­i­fied that FDA will be able to process cer­tain sub­mis­sions for gener­ic drugs us­ing car­ry­over user fees, such as changes be­ing ef­fect­ed (CBE) and pri­or ap­proval sup­ple­ments, amend­ments, an­nu­al re­ports and ap­pli­ca­tions for positron emis­sion to­mog­ra­phy (PET) drugs. He al­so said that the agency can ac­cept drug mas­ter files (DMFs) to be ref­er­enced in gener­ic drug ap­pli­ca­tions, but that the agency won’t be able to con­duct ini­tial com­plete­ness as­sess­ments on Type II ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) DMFs if the user fee has not been paid.

“Spon­sors who haven’t paid GDU­FA fa­cil­i­ty fees for FY19 shouldn’t re­mit pay­ment dur­ing the lapse pe­ri­od be­cause FDA can­not ac­cept the fees,” he added.

And if a gener­ic drug ap­pli­ca­tion ref­er­ences, for the first time af­ter 22 De­cem­ber 2018, a Type II API DMF for which the fee has not been paid, then FDA will no­ti­fy the ap­pli­cant that the fee must be paid with­in 20 cal­en­dar days. If the fee is not paid with­in 20 cal­en­dar days of that no­tice, the FDA will not re­ceive the ap­pli­ca­tion. “At this time, FDA has not de­ter­mined what ap­proach it will take if the 20-cal­en­dar-day pe­ri­od ex­pires dur­ing the lapse pe­ri­od,” Got­tlieb said.


While prais­ing the work of FDA staff con­duct­ing crit­i­cal in­spec­tions of food and drug fa­cil­i­ties who are in an “un­paid, ex­cept­ed sta­tus,” mean­ing they’re work­ing on crit­i­cal pub­lic health func­tions with­out pay or re­im­burse­ment, Got­tlieb said the em­ploy­ees’ work has not gone un­no­ticed.

“We’ll sup­port them in any way we can in their ex­e­cu­tion of these vi­tal pub­lic health func­tions. To­ward these goals we’re adopt­ing new pro­ce­dures that’ll re­duce the like­li­hood that they ac­crue bal­ances on their gov­ern­ment trav­el cred­it cards for cost of air­fare and ho­tel/lodg­ing,” he added.

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Im­age: Scott Got­tlieb. SHUT­TER­STOCK


Zachary Brennan

managing editor, RAPS

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