Biden wants a review of the API supply chain. Will that parlay into an effort to ‘onshore’ drug manufacturing? – Endpoints News

When for­mer Pres­i­dent Don­ald J. Trump was vot­ed out of of­fice Nov. 2, his gung-ho ef­fort to “on­shore” drug man­u­fac­tur­ing was left most­ly up in the air. Joe Biden has been most­ly mum on whether he would con­tin­ue that ef­fort, but a new ex­ec­u­tive or­der could pro­vide a clue — at least in a few months.

In an or­der signed Wednes­day, Biden de­mand­ed a 100-day gov­ern­men­tal re­view of key sup­ply chains, in­clud­ing for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) used in Amer­i­can drugs.

Biden’s ef­fort doesn’t amount to full-scale ef­fort launched un­der the Trump ad­min­is­tra­tion to in­fuse bil­lions in­to Amer­i­can-made drug man­u­fac­tur­ers, but a key note in the pres­i­dent’s pre­pared fact sheet could in­di­cate his goal. In that doc­u­ment, his team high­light­ed that 70% of US API pro­duc­ers had moved off­shore in re­cent decades — po­ten­tial­ly threat­en­ing the sup­ply of a sta­ble sup­ply chain dur­ing fu­ture pan­demics.

Since his in­au­gu­ra­tion, it’s been un­clear whether Biden would adopt the ex­plic­it na­tivist tone of Trump’s “Buy Amer­i­ca” ini­tia­tive, which cul­mi­nat­ed in an Au­gust ex­ec­u­tive or­der aim­ing to dri­ve new in­vest­ment in on­shore drug pro­duc­tion.

That game plan some­times led to a few ques­tion­able in­vest­ments, most no­tably a $765 mil­lion loan through the ad­min­is­tra­tion’s de­vel­op­ment fi­nance arm to cam­era mak­er Ko­dak. Af­ter the loan was an­nounced, ac­cu­sa­tions of in­sid­er trad­ing and an SEC in­ves­ti­ga­tion even­tu­al­ly sent that ini­tia­tive in­to a tail­spin in Au­gust.

Mean­while, the gov­ern­ment made a more di­rect in­vest­ment in the up­start Phlow Cor­po­ra­tion in May, a pre­vi­ous­ly un­known com­pa­ny that was tapped to part­ner with gener­ics mak­er Civi­ca Rx, among oth­ers, to build a Vir­ginia plant for crit­i­cal hos­pi­tal drugs. In Jan­u­ary, Civi­ca an­nounced it would dole out $124.5 mil­lion to build its first in-house man­u­fac­tur­ing op­er­a­tion in Pe­ters­burg, Vir­ginia — close to Phlow and the oth­er part­ners in the gov­ern­ment con­tract, Med­i­cines for All In­sti­tute and AM­PAC Fine Chem­i­cals.

Out­side the gov­ern­ment’s purview, oth­er big-name play­ers have stepped up in re­cent months to put their own big down pay­ments on Amer­i­can-made drugs.

In Jan­u­ary, bil­lion­aire in­vestor Mark Cuban put his name to a new com­pa­ny dubbed Mark Cuban Cost Plus Drugs, a gener­ics start­up us­ing flat-rate mar­gins at whole­sale to dri­ve down the cost of ex­pen­sive gener­ics. The goal is even­tu­al­ly to launch more than 100 drugs on­to the mar­ket by the end of this year, but the firm will start with an­tipar­a­sitic al­ben­da­zole, which it says it will of­fer at an av­er­age price per tablet of $20 com­pared with the cur­rent av­er­age of $225 MSRP. For in­sured pa­tients, that price could go “as low as a dol­lar,” the com­pa­ny said on its web­site.