Up­dat­ed: Sen­a­tors ques­tion FDA and FTC over patent and PBM re­forms

Sen­a­tors may be back in their dis­tricts gear­ing up for next month’s elec­tions, but that isn’t stop­ping them from ques­tion­ing both the FDA and Fed­er­al Trade Com­mis­sion on mat­ters re­lat­ed to patent and PBM re­forms.

In a let­ter sent Mon­day to FTC Chair Lina Khan, Sen­ate Fi­nance Chair Ron Wyden (D-OR) and Sen. Sher­rod Brown (D-OH) com­mend­ed the reg­u­la­tor’s re­cent PBM law­suit and urged the com­mis­sion to ex­am­ine “new PBM tac­tics that ap­pear to cre­ate fur­ther bar­ri­ers to com­pe­ti­tion and harm the abil­i­ty of con­sumers to ac­cess low­er cost pre­scrip­tion drugs.”

CVS Health VP David Whitrap told End­points News, “Re­gard­ing the Sen­a­tors’ ref­er­ence to the FTC’s ex­ist­ing law­suit on in­sulin pric­ing, the FTC couldn’t be more wrong. There are three drug­mak­ers that con­trol the mar­ket, and they hiked the prices of their in­sulins in lock­step by as much as 500% pri­or to 2012.”

The sen­a­tors point to how both CVS and Cigna’s Ex­press Scripts, two of the largest PBMs, now have whol­ly-owned sub­sidiaries “that pur­port to co-man­u­fac­ture cer­tain biosim­i­lars of Hu­mi­ra” but may just be “a veiled at­tempt by PBMs to con­trol ad­di­tion­al parts of the sup­ply chain.”

A spokesper­son from Cigna’s Ex­press Scripts told End­points News, “While we’d wel­come man­u­fac­tur­ers to low­er their prices, we’re mov­ing for­ward with in­no­v­a­tive strate­gies and a com­pre­hen­sive ap­proach that con­sid­ers not just the for­mu­la­ry place­ment of biosim­i­lars, but al­so each prod­uct’s clin­i­cal ef­fi­ca­cy, in­ter­change­abil­i­ty, avail­able sup­ply, dose, and con­cen­tra­tion.”

In the let­ter, the law­mak­ers said the sub­stance of those “co-man­u­fac­tur­ing” agree­ments be­tween PBMs and phar­ma­ceu­ti­cal com­pa­nies re­mains un­clear.

“Based on avail­able in­for­ma­tion, a num­ber of the ‘man­u­fac­tur­ing’ ser­vices pro­vid­ed by PBMs are mere­ly con­sult­ing ser­vices to the phar­ma­ceu­ti­cal man­u­fac­tur­ers they are part­ner­ing with (San­doz and Boehringer In­gel­heim re­spec­tive­ly),” they wrote.

Or­ange Book re­forms?

Sep­a­rate­ly, Sen. Bill Cas­sidy (R-LA), the top Re­pub­li­can on the Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee, sent a let­ter Mon­day to FDA Com­mis­sion­er Robert Califf telling him to not let the FTC en­force the terms of when patents should be list­ed in the FDA’s di­rec­to­ry of rel­e­vant patents, known as the Or­ange Book.

The FDA cur­rent­ly plays a min­is­te­r­i­al role in re­view­ing patents and does not vet their rel­e­vance. The FTC has made sev­er­al rounds of re­quests that com­pa­nies pull patents that it be­lieves shouldn’t be in the Or­ange Book.

“Let­ting FTC en­force terms of the FD­CA is an ex­tra­or­di­nary ab­di­ca­tion of au­thor­i­ty by FDA,” Cas­sidy wrote. “Rather than de­fer to FTC ac­cu­sa­tions that drug man­u­fac­tur­ers are break­ing am­bigu­ous rules, FDA should clar­i­fy the rules for brand and gener­ic man­u­fac­tur­ers alike.”

Cas­sidy ac­knowl­edges that courts, not the FDA, “ref­er­ee whether spe­cif­ic patents should be list­ed in the Or­ange Book in the con­text of patent lit­i­ga­tion,” but he ques­tions why the FDA has re­mained silent on list­ing drug-de­vice com­bo prod­uct patents, as the agency sets the rules for list­ing patents in the Or­ange Book.

“De­spite near­ly two decades of re­quests from man­u­fac­tur­ers for more clar­i­ty, FDA has still not told in­dus­try how it should list patents for drug-de­vice com­bi­na­tions,” Cas­sidy writes. “Mean­while, FTC, with FDA’s ap­par­ent en­cour­age­ment, has filled the vac­u­um left by FDA.”

Ar­ti­cle up­dat­ed with com­ment from Ex­press Scripts and CVS Health.