The FDA is once again re­turn­ing to its hot­ly-con­test­ed qual­i­ty met­rics pro­gram for phar­ma man­u­fac­tur­ers, even as com­pa­nies have ex­pressed ma­jor reser­va­tions.

The agency’s fo­cus on qual­i­ty met­rics be­gan in 2015 and con­tin­ued with a heav­i­ly re­vised draft guid­ance (fol­low­ing in­dus­try cri­tiques) on how to sub­mit met­rics da­ta, in­clud­ing qual­i­ty-re­lat­ed com­plaints. Even­tu­al­ly, the guid­ance spawned two FDA pi­lot projects in 2018.

The FDA has main­tained its fo­cus on the top­ic of these vol­un­tary qual­i­ty met­rics even as bio­phar­ma com­pa­nies have ques­tioned the val­ue and util­i­ty of the da­ta and cri­tiqued the in­creased bur­den of col­lect­ing and sub­mit­ting the da­ta.

But the FDA stress­es in a new up­date on its qual­i­ty met­rics pro­gram on Tues­day that ad­di­tion­al da­ta can help both the FDA and the sup­ply chain, which needs to have a bet­ter un­der­stand­ing of which man­u­fac­tur­ers are go­ing above and be­yond the sta­tus quo. Cur­rent GMP com­pli­ance “does not nec­es­sar­i­ly in­di­cate” whether a man­u­fac­tur­er is in­vest­ing in im­prove­ments and striv­ing for con­sis­tent con­trol over its man­u­fac­tur­ing per­for­mance and qual­i­ty, FDA said.

Michael Ganio

“The fact that they’re [FDA] con­tin­u­ing to look at this is promis­ing,” Michael Ganio, se­nior di­rec­tor at the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists, told End­points News. “And we know they rec­og­nize the im­por­tance of qual­i­ty in drugs in the sup­ply chain….it makes sense to give some sort of in­cen­tive or mea­sure­ment so pur­chasers have more in­for­ma­tion on whether they’re re­ward­ing more re­li­able prod­uct man­u­fac­tur­ers.”

FDA al­so says it’s con­sid­er­ing changes and seeks feed­back on some as­pects of its qual­i­ty met­rics re­port­ing pro­gram.

“To pro­vide flex­i­bil­i­ty to man­u­fac­tur­ers, FDA would fo­cus less on stan­dard­iza­tion of qual­i­ty met­rics and de­f­i­n­i­tions,” the agency said Tues­day. “In­stead, FDA would iden­ti­fy prac­tice ar­eas that are crit­i­cal to en­sure sus­tain­able prod­uct qual­i­ty and avail­abil­i­ty and would per­mit man­u­fac­tur­ers to se­lect a met­ric(s) from each prac­tice area that are mean­ing­ful and en­able es­tab­lish­ments to iden­ti­fy con­tin­u­al im­prove­ment op­por­tu­ni­ties.”

Rather than set met­ric de­f­i­n­i­tions on how es­tab­lish­ments cal­cu­late par­tic­u­lar met­rics, the FDA said it will al­low re­port­ing es­tab­lish­ments (i.e. API and fin­ished dose man­u­fac­tur­ers, among oth­ers) to se­lect the most ap­pro­pri­ate met­ric(s) from each prac­tice area and in­form FDA how the met­rics were cal­cu­lat­ed.

Based on feed­back from the pi­lot par­tic­i­pants, the agency said it iden­ti­fied four gen­er­al ar­eas as ap­pro­pri­ate for its met­rics pro­gram:

(1) Man­u­fac­tur­ing process per­for­mance

(2) Phar­ma­ceu­ti­cal qual­i­ty sys­tem ef­fec­tive­ness

(3) Lab­o­ra­to­ry per­for­mance

(4) Sup­ply chain ro­bust­ness

Ex­am­ples of qual­i­ty met­rics as­so­ci­at­ed with each of these ar­eas in­clude (for area num­ber 1) a met­ric on the pro­por­tion of lots man­u­fac­tured with­out the oc­cur­rence of a non-con­for­mance, (for area num­ber 2) a mea­sure of the pro­por­tion of re­cur­ring de­vi­a­tion mea­sures, (for area num­ber 3) a mea­sure that in­di­cates a lab’s abil­i­ty to ac­cu­rate­ly per­form tests, and (for area num­ber 4) a mea­sure of the ex­tent to which ship­ments are de­liv­ered to their des­ti­na­tion con­tain­ing the cor­rect quan­ti­ty and ac­cord­ing to the or­der’s sched­ule.

As far as ques­tions for in­dus­try, the FDA wants to know if stake­hold­ers agree that re­port­ing should be ag­gre­gat­ed at an es­tab­lish­ment lev­el, and whether re­port­ing at an es­tab­lish­ment lev­el would help fa­cil­i­tate the sub­mis­sion of qual­i­ty met­rics da­ta by con­tract man­u­fac­tur­ers.

The Phar­ma & Bio­phar­ma Out­sourc­ing As­so­ci­a­tion, which rep­re­sents CD­MOs, told End­points that it’s look­ing in­to this lat­est an­nounce­ment and it ap­pears as though the FDA does want to im­ple­ment qual­i­ty met­rics re­port­ing in some way, shape or form. PBOA said it’s look­ing for­ward to pro­vid­ing a de­tailed re­sponse to the dock­et.

The FDA al­so wants stake­hold­ers’ thoughts on what are the crit­i­cal com­po­nents of “a ro­bust qual­i­ty cul­ture,” and whether any of the ex­am­ples of qual­i­ty met­rics pro­posed by the FDA “would not be an ap­pro­pri­ate mea­sure.”

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

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