As­traZeneca is break­ing ground on a multi­bil­lion-dol­lar API fa­cil­i­ty in Vir­ginia, mak­ing it the lat­est com­pa­ny to start build­ing af­ter Pres­i­dent Don­ald Trump threat­ened 100% tar­iffs on drug­mak­ers not start­ing con­struc­tion in the US.

The orig­i­nal val­ue of the fa­cil­i­ty was $4 bil­lion, but this will in­crease as of Thurs­day, a com­pa­ny spokesper­son told End­points News. The build is part of As­traZeneca’s $50 bil­lion pledge to the US, which it an­nounced in Ju­ly.

Late last month, Trump warned in a so­cial me­dia post that start­ing Oct. 1, com­pa­nies would face a 100% tar­iff on brand­ed phar­ma prod­ucts un­less they are build­ing man­u­fac­tur­ing plants in the US. Yet, on Oct. 1, the White House con­firmed to End­points that the levies will be de­layed as they are still in prepa­ra­tion stages.

Lawyers are field­ing in­creas­ing in­quiries from bio­phar­ma com­pa­nies on Pres­i­dent Don­ald Trump’s 100% phar­ma tar­iffs, but many are un­sure how to ad­vise their clients with gap­ing holes in the ad­min­is­tra­tion's an­nounce­ments.

“There's a lot of chat­ter be­hind the scenes and at­tempts to un­der­stand and get clar­i­ty on how the next it­er­a­tion spells out,” Lynn Mehler, phar­ma reg­u­la­to­ry lawyer at Lon­don-head­quar­tered firm Hogan Lovells, told End­points News.

Trump on Sept. 25 an­nounced via so­cial me­dia that bio­phar­ma com­pa­nies not start­ing con­struc­tion projects in the US by Oct.1 would face 100% tar­iffs on brand­ed drugs. But on Oct. 1, a White House of­fi­cial con­firmed to End­points these levies would be de­layed, as they are still be­ing pre­pared.

The UK is re­port­ed­ly pre­pared to pay up to 25% more for drugs, as bio­phar­ma com­pa­nies urge the gov­ern­ment to spend more on med­i­cines and Pres­i­dent Don­ald Trump pres­sures drug­mak­ers for low­er prices in the US.

The UK’s Na­tion­al In­sti­tute for Health and Care Ex­cel­lence (NICE) — its cost-ef­fec­tive­ness watch­dog — weighs whether to rec­om­mend a new drug to the NHS, tak­ing in­to ac­count what’s called a qual­i­ty-ad­just­ed life year (QALY). If a drug is be­low the QALY thresh­old, NICE will rec­om­mend the drug to the NHS.

The UK has a new pro­pos­al that in­cludes rais­ing that thresh­old by as much as 25%, ac­cord­ing to a Wednes­day Politi­co re­port cit­ing two un­named in­dus­try sources. Cur­rent­ly, a QALY’s up­per lim­it is set at £30,000 a year.

The FDA has re­vealed a new pi­lot pro­gram, dubbed the ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA), which will en­cour­age drug­mak­ers to use do­mes­tic sup­plies of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents for gener­ic drugs.

The new pro­gram will speed up the re­view process for gener­ic drugs for drug­mak­ers who man­u­fac­ture prod­ucts in the US, ac­cord­ing to the FDA's Fri­day press re­lease. Gener­ic drugs make up about 92% of US re­tail and mail phar­ma­cy pre­scrip­tions, ac­cord­ing to a Brook­ings In­sti­tute re­port from March.

Com­pa­nies will be el­i­gi­ble for the pi­lot pro­gram if they are ex­clu­sive­ly us­ing US-based API sources, and if they con­duct any bioe­quiv­a­lence test­ing in the US.

“Over-re­liance on for­eign drug man­u­fac­tur­ing and test­ing cre­ates risks both to na­tion­al se­cu­ri­ty and pa­tient ac­cess, and un­der­mines in­vest­ments in US re­search, man­u­fac­tur­ing and pro­duc­tion,” CDER di­rec­tor George Tid­marsh said in the an­nounce­ment.

Eli Lil­ly is in­vest­ing $1 bil­lion over the next “sev­er­al years” in­to its "con­tract man­u­fac­tur­ing" foot­print in In­dia, a spokesper­son con­firmed to End­points News. 

The In­di­anapo­lis-head­quar­tered com­pa­ny did­n't give any de­tails on ex­act­ly where the in­vest­ment will be made, apart from an es­tab­lish­ing a new man­u­fac­tur­ing and qual­i­ty hub in Hy­der­abad, ac­cord­ing to the Mon­day re­lease. Re­cruit­ment at this fa­cil­i­ty will be­gin im­me­di­ate­ly, with roles open for chemists and en­gi­neers, among oth­ers, the re­lease said.

"To­day in In­dia, Lil­ly an­nounced plans to in­vest more than $1 bil­lion over the next sev­er­al years in­to new con­tract man­u­fac­tur­ing in In­dia," the spokesper­son told End­points. Lil­ly did not re­spond to End­points' re­quest for com­ment on how many sites will be built, where they will be lo­cat­ed and what prod­ucts they will man­u­fac­ture.

UK-head­quar­tered cell ther­a­py man­u­fac­tur­er My­tos is launch­ing its first CD­MO fa­cil­i­ty in the coun­try, with plans to es­tab­lish an­oth­er fa­cil­i­ty else­where in the next four years.

“What's great about au­to­mat­ed man­u­fac­tur&