FDA’s CDER un­veils de­tails of re­or­ga­ni­za­tion

The US Food and Drug Ad­min­is­tra­tion’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) on Thurs­day an­nounced the de­tails of a ma­jor re­or­ga­ni­za­tion, af­fect­ing near­ly one-third of CDER.

The pro­posed re­or­ga­ni­za­tion will im­pact the Of­fice of New Drugs, Of­fice of Com­pli­ance, Of­fice of Ex­ec­u­tive Pro­grams, and Of­fice of Com­mu­ni­ca­tions and has been sub­mit­ted to HHS, though still must be ap­proved by HHS and sub­mit­ted to Con­gress for con­cur­rence. The changes will be in ef­fect once ap­proval is re­ceived and the 30-day con­gres­sion­al no­ti­fi­ca­tion has lapsed, FDA said.

FDA al­so not­ed that the changes are not part of a sep­a­rate ef­fort re­lat­ed to the New Drugs Reg­u­la­to­ry pro­gram Mod­ern­iza­tion, which is a longer-term ef­fort in­clud­ing a broad­er re­or­ga­ni­za­tion of OND.

Of­fice of New Drugs (OND)

The changes an­nounced Thurs­day in­clude the cre­ation of a new Of­fice of Ther­a­peu­tic Bi­o­log­ics and Biosim­i­lars (OTBB) with­in OND, which will house pol­i­cy staff and sci­en­tif­ic re­view staff. The re­struc­tur­ing will al­so re­align staff from the OND Im­me­di­ate Of­fice to the new OTBB and will help in im­ple­ment­ing the reau­tho­rized Biosim­i­lar User Fee Act (Bs­U­FA II).

“OTBB will give biosim­i­lar and in­ter­change­able prod­uct re­view a stronger in­fra­struc­ture with re­sources to stream­line and ad­vance pol­i­cy de­vel­op­ment,” FDA said. “The in­creas­ing com­plex­i­ties and vis­i­bil­i­ty of this pro­gram re­quire a ded­i­cat­ed of­fice to ef­fi­cient­ly and ef­fec­tive­ly achieve cross-or­ga­ni­za­tion­al co­or­di­na­tion and col­lab­o­ra­tion.”

Of­fice of Com­pli­ance (OC)

The Of­fice of Un­ap­proved Drugs and La­bel­ing Com­pli­ance will house the Di­vi­sion of Com­pound­ed Drugs, for­mer­ly known as the Di­vi­sion of Pre­scrip­tion Drugs.

“This change will bet­ter re­flect our crit­i­cal work re­lat­ing to com­pound­ing pol­i­cy and over­sight, as the di­vi­sion will ab­sorb the func­tions of the for­mer Com­pound­ing and Phar­ma­cy Prac­tice Branch. It will es­tab­lish three new branch­es re­lat­ing to com­pound­ing pol­i­cy, reg­u­la­to­ry ac­tions, and op­er­a­tions – and re­align the Pre­scrip­tion Drugs Branch with a new Di­vi­sion of Un­ap­proved New Drugs, for­mer­ly the Di­vi­sion of Non-Pre­scrip­tion Drugs & Health Fraud. New branch names will bet­ter re­flect the di­vi­sion’s mis­sion and goals,” FDA said.

In ad­di­tion, the Of­fice of Man­u­fac­tur­ing Qual­i­ty (OMQ) will es­tab­lish a third drug qual­i­ty di­vi­sion with two branch­es for glob­al com­pli­ance. And the Of­fice of Drug Se­cu­ri­ty, In­tegri­ty, and Re­sponse will re­name its Di­vi­sion of Im­ports, Ex­ports, and Re­calls to the Di­vi­sion of Glob­al Drug Dis­tri­b­u­tion and Pol­i­cy to re­flect the agency’s re­spon­si­bil­i­ty in en­sur­ing the safe­ty and qual­i­ty of drug prod­ucts flow­ing in­to and out of the US.

Of­fice of Ex­ec­u­tive Pro­grams (OEP)

OEP is re­struc­tur­ing to ad­dress the grow­ing vol­ume and com­plex­i­ty of man­ag­ing CDER’s ex­ec­u­tive pro­grams.
“The OEP changes will es­tab­lish four staff groups with­in OEP’s Im­me­di­ate Of­fice fo­cus­ing on spe­cial projects, ex­ec­u­tive sec­re­tari­at mat­ters, leg­isla­tive ac­tiv­i­ties, and pro­gram man­age­ment and analy­sis – ab­sorb­ing the func­tions of the for­mer Di­vi­sion of Ex­ec­u­tive Op­er­a­tions. The re­struc­tur­ing will al­so es­tab­lish two branch­es with­in the Di­vi­sion of Ad­vi­so­ry Com­mit­tee and Con­sul­tant Man­age­ment to man­age and over­see ad­vi­so­ry com­mit­tee and con­flict of in­ter­est mat­ters,” FDA said.

Of­fice of Com­mu­ni­ca­tions (OCOMM)

OCOMM’s changes in­clude es­tab­lish­ing three branch­es with­in the ex­ist­ing Di­vi­sion of Drug In­for­ma­tion. OCOMM will al­so re­name two di­vi­sions to bet­ter re­flect their ex­pand­ed mis­sion. The Di­vi­sion of Health Com­mu­ni­ca­tions will be­come the Di­vi­sion of Pub­lic Ed­u­ca­tion and Out­reach, and the Di­vi­sion of On­line Com­mu­ni­ca­tions will be­come the Di­vi­sion of Dig­i­tal and On­line Com­mu­ni­ca­tion.

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. 


Zachary Brennan

managing editor, RAPS

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