The fed­er­al gov­ern­ment of­fi­cial­ly shut down at mid­night, lead­ing to tens of thou­sands of fur­loughs at HHS and fur­ther com­pli­cat­ing the work of a skele­ton staff at the FDA.

De­moc­rats and Re­pub­li­cans con­tin­ue to strug­gle to come to terms on a fund­ing deal and are blam­ing one an­oth­er for the im­passe.

If a fund­ing lapse reach­es a sec­ond day, HHS said it will fur­lough more than 32,000 staff and that at the FDA, on­ly 86% — or 13,872 staff — will be re­tained. The FDA's “abil­i­ty to pro­tect and pro­mote pub­lic health and safe­ty would be sig­nif­i­cant­ly im­pact­ed, with many ac­tiv­i­ties de­layed or paused,” HHS said in its con­tin­gency plans.

George Tid­marsh, di­rec­tor of the FDA's drug cen­ter, said in a now-delet­ed so­cial me­dia post that the agency would re­con­sid­er the use of sur­ro­gate end­points that have been used to ap­prove drugs more quick­ly than the stan­dard ap­proval process.

While not­ing that "there is no doubt" that the use of sur­ro­gate end­points "has ben­e­fit­ed pa­tients by bring­ing valu­able treat­ments to pa­tients soon­er" through the FDA's ac­cel­er­at­ed ap­proval path­way, "there have been no­table fail­ures in con­fir­ma­to­ry tri­als," Tid­marsh wrote Mon­day. "We will be tak­ing a close look at the use of sur­ro­gate end­points to see where we can fur­ther ac­cel­er­ate promis­ing drugs faster while re­quir­ing com­pa­nies to per­form the tri­als nec­es­sary to con­firm ac­tu­al clin­i­cal ben­e­fit."

The White House her­ald­ed its new drug pric­ing agree­ment with Pfiz­er, say­ing it was pri­or­i­tiz­ing fair­ness for Amer­i­can con­sumers and that it would be the first of many deals struck with drug man­u­fac­tur­ers.

But the re­al im­pact of Tues­day’s an­nounce­ment may be lim­it­ed, and how peo­ple ex­pe­ri­ence it will de­pend al­most en­tire­ly on where they sit with­in the com­pli­cat­ed US health­care sys­tem and what med­i­cines they take.

A key part of Tues­day’s an­nounce­ment is a new web­site that will of­fer list-price dis­counts on a di­rect-to-con­sumer plat­form built by the gov­ern­ment, TrumpRx, that Pfiz­er said will in­clude the ma­jor­i­ty of its pri­ma­ry care treat­ments and some spe­cial­ty brand med­i­cines.

Sev­er­al drug­mak­ers an­nounced new dis­counts and di­rect-to-con­sumer of­fer­ings on Mon­day as they run up against Pres­i­dent Don­ald Trump’s dead­line for phar­ma com­pa­nies to bring their US drug prices in line with fel­low na­tions.

Ab­b­Vie, No­var­tis and Boehringer In­gel­heim each joined their peers in mak­ing price-re­lat­ed con­ces­sions tied to the pres­i­dent’s push for "most fa­vored na­tion" pric­ing. All three were among the com­pa­nies that re­ceived let­ters from Trump in late Ju­ly, de­mand­ing they do more to low­er prices by Sept. 29 af­ter he was dis­sat­is­fied with the ini­tial pace of progress fol­low­ing his ex­ec­u­tive or­der in May.

Pres­i­dent Don­ald Trump said that he'll slap a 100% tar­iff on drug­mak­er­s' prod­ucts un­less the com­pa­nies are build­ing a man­u­fac­tur­ing plant in the US.

In a Truth So­cial post on Thurs­day, Trump said that the new tar­iff would go in­to ef­fect on Oct. 1 "un­less a Com­pa­ny IS BUILD­ING their Phar­ma­ceu­ti­cal Man­u­fac­tur­ing Plant in Amer­i­ca." Trump de­fined that as "'break­ing ground' and/or 'un­der con­struc­tion.'"

Many drug­mak­ers have made pledges to in­vest bil­lions of dol­lars in new US man­u­fac­tur­ing. But it can take many months just to pick sites and get ap­provals for those projects, and years to com­plete them, and it's not clear how many of those projects have be­gun or are ready to start.

Over the last few months on Post-Hoc Live, we’ve done shows about the rapid rise of Chi­na’s biotech in­dus­try, and how some in the in­dus­try are push­ing for re­stric­tions to block or slow com­pe­ti­tion. To­day, we talked to for­mer FDA com­mis­sion­er Scott Got­tlieb about how the US needs to change if it wants to stay com­pet­i­tive.

Got­tlieb (who is now a ven­ture in­vestor and cor­po­rate board mem­ber) has a re­cent opin­ion piece ar­gu­ing that the US needs to change its ap­proach to clin­i­cal tri­als and reg­u­la­tion, and use its (maybe short-lived) tech­no­log­i­cal ad­van­tages if it wants to keep its lead in an in­dus­try it spent decades build­ing.

You can watch our con­ver­sa­tion on our YouTube livestream or lis­ten on Ap­ple Pod­casts and Spo­ti­fy.