Fol­low­ing up on Trump's or­ders, the FDA wants to know: which reg­u­la­tions and pa­per­work re­quire­ments need to go?

As part of work un­der two ex­ec­u­tive or­ders, FDA cen­ters on Thurs­day sought com­ments on which ex­ist­ing reg­u­la­tions and re­lat­ed pa­per­work re­quire­ments could be mod­i­fied, re­pealed or re­placed, to re­duce the bur­den on in­dus­try while al­low­ing the reg­u­la­tor to con­tin­ue its pub­lic health mis­sion while ful­fill­ing statu­to­ry oblig­a­tions.

Back in Feb­ru­ary, when Pres­i­dent Don­ald Trump first an­nounced his or­der to re­duce reg­u­la­to­ry bur­dens, sev­er­al ex­perts point­ed Fo­cus to some out­dat­ed reg­u­la­tions that could be re­moved with lit­tle im­pact on pub­lic health and the agency’s mis­sion, though there are still ques­tions as to what types of reg­u­la­tions will be tar­get­ed.

And as An­na Abram, FDA’s deputy com­mis­sion­er for pol­i­cy, plan­ning, leg­is­la­tion and analy­sis, not­ed in a blog post on Thurs­day, there’s “a lot of ground to cov­er” as FDA’s reg­u­la­tions com­prise more than 4,000 pages in the Code of Fed­er­al Reg­u­la­tions.

In gen­er­al, though, the agency says it’s look­ing for com­ment and sup­port­ing tech­ni­cal, sci­en­tif­ic, eco­nom­ic or oth­er da­ta from those sig­nif­i­cant­ly af­fect­ed by FDA reg­u­la­tions, in­clud­ing con­sumers, pa­tients and care­givers, re­searchers, health­care in­sti­tu­tions, the reg­u­lat­ed in­dus­try, trade as­so­ci­a­tions, pub­lic in­ter­est or­ga­ni­za­tions, acad­e­mia, and state, lo­cal and trib­al gov­ern­ments.

“Some reg­u­la­tions may not ad­e­quate­ly re­flect ad­vances in sci­ence, tech­nol­o­gy or changes in in­dus­try prac­tice. Oth­ers may be geared to­ward prod­ucts and prac­tices that have large­ly ceased to ex­ist,” Abram said, of­fer­ing the ex­am­ple of how the ma­nip­u­la­tion of FDA’s rules on Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies (REMS) can cre­ate ob­sta­cles to the time­ly en­try of gener­ic com­pe­ti­tion.

Fea­tured in Thurs­day’s Fed­er­al Reg­is­ter no­tices are ques­tions FDA says it is us­ing to guide its ini­tial re­view, in­clud­ing:

  • Is the reg­u­la­tion still cur­rent, or is it out­dat­ed or un­nec­es­sary in some way?
  • Have reg­u­lat­ed en­ti­ties had dif­fi­cul­ties com­ply­ing with the reg­u­la­tion?
  • Does the reg­u­la­tion im­pose re­quire­ments that are al­so pro­vid­ed for in vol­un­tary or con­sen­sus stan­dards or guid­ance by third par­ty or­ga­ni­za­tions (e.g., In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion, In­ter­na­tion­al Or­ga­ni­za­tion for Stan­dard­iza­tion, Codex Al­i­men­ta­r­ius)?
  • Does the reg­u­la­tion con­tain re­dun­dant, out­dat­ed, or un­nec­es­sary col­lec­tions of in­for­ma­tion or re­ten­tion of records, e.g., re­port­ing, record­keep­ing, or la­bel­ing re­quire­ments?
  • Could the goal of the reg­u­la­tion be achieved by less cost­ly means that would pro­vide the same lev­el of pub­lic health pro­tec­tion?
  • What fac­tors should FDA con­sid­er in se­lect­ing and pri­or­i­tiz­ing reg­u­la­tions and re­port­ing re­quire­ments for re­form?


Re­view of Ex­ist­ing Gen­er­al Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments of the Food and Drug Ad­min­is­tra­tion

Re­view of Ex­ist­ing Cen­ter for Drug Eval­u­a­tion and Re­search Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments

Re­view of Ex­ist­ing Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments

Re­view of Ex­ist­ing Cen­ter for De­vices and Ra­di­o­log­i­cal Health Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments

Im­age: Get­ty, End­points News, The White House

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 for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

Norbert Bischofberger. Kronos

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

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Until now.

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Vas Narasimhan, AP Images

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

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