Cit­i­zen pe­ti­tions: FDA re­vis­es guid­ance to block drug­mak­ers from abus­ing the sys­tem

The FDA on Tues­day is­sued a re­vised draft guid­ance de­signed to al­low for the FDA to re­ject 505(q) pe­ti­tions if the agency de­ter­mines the pri­ma­ry pur­pose of the pe­ti­tion is to de­lay the ap­proval of an ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA).

“We be­lieve this will pro­vide an ad­di­tion­al de­ter­rent to pur­su­ing these tac­tics,” the FDA said.

The new ap­proach to re­view­ing pe­ti­tions would al­so help the FDA fo­cus its re­sources on ad­dress­ing pe­ti­tions that are most like­ly to present an ob­sta­cle to the avail­abil­i­ty of gener­ic drugs.

“Once an ap­pli­ca­tion is sub­mit­ted, the FDA has a goal date of mak­ing an ap­proval de­ci­sion on that ap­pli­ca­tion with­in 10 months, or, for some pri­or­i­ty ap­pli­ca­tions, with­in eight months. If a cit­i­zen pe­ti­tion is re­ceived while a prod­uct ap­pli­ca­tion is al­ready un­der re­view, and if the goal date for that re­view falls with­in the next 150 days, the draft guid­ance states that the FDA would ex­pect to re­spond to that pe­ti­tion with­in 150 days,” the FDA said.

Un­der the sec­tion, “How Does FDA De­ter­mine if a Pe­ti­tion Would De­lay Ap­proval of an AN­DA, 505(b)(2) Ap­pli­ca­tion, or 351(k) Ap­pli­ca­tion,” the FDA ex­plains is­sues that could im­pli­cate the pub­lic health in­clude, for ex­am­ple, “(1) whether a pro­posed gener­ic drug prod­uct is bioe­quiv­a­lent to the ref­er­ence list­ed drug or (2) whether an in­di­ca­tion can be safe­ly omit­ted from the la­bel­ing be­cause that in­di­ca­tion is pro­tect­ed by a patent.”

To fur­ther dis­suade com­pa­nies from im­prop­er­ly us­ing these pe­ti­tions, the FDA al­so said it in­tends to high­light in its an­nu­al re­port to Con­gress the de­ter­mi­na­tions of pe­ti­tions that are judged to have been sub­mit­ted to de­lay an ap­proval. The guid­ance al­so out­lines the FDA’s in­ten­tion to re­fer these mat­ters to the Fed­er­al Trade Com­mis­sion.

Oth­er ques­tions an­swered in the guid­ance in­clude, “How Does FDA De­ter­mine if Sec­tion 505(q) Ap­plies to a Par­tic­u­lar Pe­ti­tion?” and “What Is the Re­la­tion­ship Be­tween the Re­view of Pe­ti­tions Un­der Sec­tion 505(q) and the Re­view of AN­DAs, 505(b)(2) Ap­pli­ca­tions, and 351(k) Ap­pli­ca­tions for Which the Agency Has Not Yet Made a Fi­nal De­ci­sion on Ap­prov­abil­i­ty?” and “What Con­sid­er­a­tions May Sug­gest That a Pe­ti­tion Was Sub­mit­ted for the Pri­ma­ry Pur­pose of De­lay­ing Ap­proval of an Ap­pli­ca­tion?”

This 17-page guid­ance, up­dat­ing a pre­vi­ous ver­sion from 2014, al­so de­scribes how FDA in­ter­prets the pro­vi­sions of sec­tion 505(q) re­quir­ing that (1) a pe­ti­tion in­clude a cer­ti­fi­ca­tion and (2) sup­ple­men­tal in­for­ma­tion or com­ments to a pe­ti­tion in­clude a ver­i­fi­ca­tion.

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

John Hood [file photo]

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