Ma­jor dereg­u­la­tion? FDA with­draws sev­er­al rules and reg­u­la­tions re­lat­ed to med­ical prod­ucts

Al­most a year ago, Pres­i­dent Don­ald Trump told phar­ma­ceu­ti­cal ex­ec­u­tives that his ad­min­is­tra­tion would cut 75% to 80% of FDA reg­u­la­tions, “at a lev­el no one has ever seen be­fore.”

Since those com­ments last Jan­u­ary, the FDA has with­drawn the most rule­mak­ings of any De­part­ment of Health and Hu­man Ser­vices agency, though on­ly a hand­ful are re­lat­ed to med­ical prod­ucts (the oth­ers are to­bac­co re­lat­ed) and it’s un­clear how the with­draw­al of these pro­pos­als and reg­u­la­tions so far in 2017 will im­pact pa­tient safe­ty or in­dus­try bur­dens.

new re­port from the non­prof­it Pub­lic Cit­i­zen, re­leased this week, dis­cuss­es not on­ly the reg­u­la­tions with­drawn in 2017 but how this ad­min­is­tra­tion “has done a lot to slow down or stop on­go­ing rule­mak­ings.”

For in­stance, ac­cord­ing to HHS’ reg­u­la­to­ry agen­da pub­lished in Au­gust, the fi­nal­iza­tion of a rule on drug la­bels, “to re­flect cer­tain types of new­ly ac­quired in­for­ma­tion in ad­vance of FDA’s re­view of such changes,” has been pushed back in­def­i­nite­ly, the fi­nal­iza­tion of a rule re­lat­ed to ac­cept­ing cer­tain clin­i­cal da­ta to bring new med­ical de­vices to mar­ket has been de­layed to next month and the fi­nal­iza­tion of an FDA rule on post­mar­ket­ing safe­ty re­quire­ments has been pushed back to Oc­to­ber 2018.

And since Trump took of­fice, with­drawals of rule­mak­ings and reg­u­la­tions re­lat­ed to med­ical prod­ucts oc­curred last April and June and in­clude one on pa­tient la­bel­ing, “to help pa­tients use their pre­scrip­tion drug prod­ucts safe­ly and ef­fec­tive­ly”; an­oth­er on clin­i­cal tri­als that would have up­dat­ed the in­ves­ti­ga­tion­al new drug (IND) ap­pli­ca­tion reg­u­la­tions to “bet­ter pro­tect the rights, safe­ty, and wel­fare of sub­jects and help en­sure the in­tegri­ty of clin­i­cal tri­al da­ta”; a third on up­dat­ing and har­mo­niz­ing cur­rent good man­u­fac­tur­ing prac­tice (cGMP) reg­u­la­tions for fin­ished phar­ma­ceu­ti­cals; a fourth to re­vise reg­u­la­tions for cGMP with re­gard to com­po­nents used in man­u­fac­tur­ing fin­ished phar­ma­ceu­ti­cals; and a fifth that would have reg­u­lat­ed the for­mat and con­tent of re­ports in­tend­ed to demon­strate sub­stan­tial equiv­a­lence.

But on the top­ic of whether 75% to 80% of FDA reg­u­la­tions will be cut mov­ing for­ward, a White House spokesman re­ferred Fo­cus to FDA, which re­ferred Fo­cus to this blog post from An­na Abram, FDA’s deputy com­mis­sion­er, on con­sid­er­a­tions the agency takes in de­ter­min­ing which rule­mak­ings to with­draw.

The post high­lights com­ments sought by FDA on which rule­mak­ings could be mod­i­fied, re­pealed or re­placed, to re­duce the bur­den on in­dus­try while al­low­ing FDA to con­tin­ue its pub­lic health mis­sion, though ear­li­er this month, FDA Com­mis­sion­er Scott Got­tlieb said a lot of FDA’s reg­u­la­tions are de-reg­u­la­to­ry in na­ture so they do not need to be cut.

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

Brent Saunders [Getty Photos]

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

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