A jog down mem­o­ry lane: How many times have De­moc­rats tried and failed to win drug price ne­go­ti­a­tions?

Af­ter more than a decade of failed at­tempts at pass­ing a bill to al­low Medicare to ne­go­ti­ate drug prices, De­moc­rats this au­tumn may be on the cusp of van­quish­ing their past.

Since at least 2007, var­i­ous forms of drug pric­ing leg­is­la­tion have lin­gered and seen ex­ten­sive op­po­si­tion from Re­pub­li­cans, who’ve long main­tained that ma­jor cuts to Big Phar­ma prof­its could spell the end of the next promis­ing drug be­fore it even be­gins to be de­vel­oped.

Two ma­jor things have changed be­tween 2007 and now: One, De­moc­rats on­ly need a sim­ple ma­jor­i­ty (and they have a sim­ple ma­jor­i­ty) in the Sen­ate to pass a bill, via a process known as rec­on­cil­i­a­tion. That’s a must-have, con­sid­er­ing how many Re­pub­li­cans will like­ly op­pose a bill that pro­vides the gov­ern­ment with ne­go­ti­at­ing pow­er.

The oth­er key: the amount of mon­ey at stake, in terms of not on­ly slow­ing down bio­phar­ma R&D in some ca­pac­i­ty, as PhRMA will ex­plain to any­one who will lis­ten, but on the oth­er side too: gov­ern­ment sav­ings and po­ten­tial­ly more mon­ey in pa­tients’ pock­ets.

So how much might the gov­ern­ment save with these types of ne­go­ti­a­tions? The non­par­ti­san CBO re­cent­ly es­ti­mat­ed that ne­go­ti­a­tion pro­vi­sions in House Speak­er Nan­cy Pelosi’s drug pric­ing bill (which, so far, still re­mains in the grave­yard of drug price ne­go­ti­a­tion bills), would re­duce fed­er­al spend­ing by about $450 bil­lion over the next decade.

Tak­ing a step back, and to bet­ter frame what may or may not end up be­ing an im­pact­ful au­tumn in the land of drug pric­ing, here’s what’s been in­tro­duced in re­cent years, why we’re in this cur­rent po­si­tion, and why De­moc­rats have been ea­ger to re­al­ize these po­ten­tial sav­ings, de­spite the many un­knowns around R&D pres­sure.

Mul­ti­ple, un­suc­cess­ful at­tempts

The gov­ern­ment’s in­abil­i­ty to ne­go­ti­ate drug prices be­gan with a law from al­most 20 years ago, known as the Medicare Pre­scrip­tion Drug, Im­prove­ment, and Mod­ern­iza­tion Act of 2003, which ex­press­ly for­bids gov­ern­ment drug price ne­go­ti­a­tions, stat­ing in its so-called “non­in­ter­fer­ence” clause, “the [HHS] Sec­re­tary may not in­ter­fere with the ne­go­ti­a­tions be­tween drug man­u­fac­tur­ers and phar­ma­cies and PDP spon­sors and may not re­quire a par­tic­u­lar for­mu­la­ry or in­sti­tute a price struc­ture for the re­im­burse­ment of cov­ered part D drugs.”

Ever since, al­low­ing Medicare ne­go­ti­a­tions be­tween the gov­ern­ment and bio­phar­ma com­pa­nies has been a pet project of De­moc­rats, par­tic­u­lar­ly as it might lead to these po­ten­tial­ly sig­nif­i­cant sav­ings. In ad­di­tion to fed­er­al sav­ings, De­moc­rats may be look­ing to bring down the prices of spe­cial­ty drugs, which ac­cord­ing to a 2019 Con­gres­sion­al Re­search Ser­vice re­port, are about 1% of Part D pre­scrip­tions but ac­count for more than 25% of spend­ing, which is an in­crease from 6% in 2007.

Sen. Ron Wyden (D-OR), who’s tak­ing the lead in craft­ing the De­moc­rats’ drug pric­ing pro­pos­al for this fall, pre­vi­ous­ly craft­ed a bi­par­ti­san drug pric­ing bill in 2019 with Sen. Chuck Grass­ley (R-IA) but that bill did not in­clude Medicare ne­go­ti­a­tions. Wyden has been work­ing on the is­sue since at least 2007, when he re­ceived word from the CBO that the fed­er­al gov­ern­ment can’t just use car­rots but may al­so need a stick to get low­er prices.

“Ne­go­ti­a­tion is like­ly to be ef­fec­tive on­ly if it is ac­com­pa­nied by some source of pres­sure on drug man­u­fac­tur­ers to se­cure price con­ces­sions. The au­thor­i­ty to es­tab­lish a for­mu­la­ry, set prices ad­min­is­tra­tive­ly, or take oth­er reg­u­la­to­ry ac­tions against firms fail­ing to of­fer price re­duc­tions could give the Sec­re­tary the abil­i­ty to ob­tain sig­nif­i­cant dis­counts in ne­go­ti­a­tions with drug man­u­fac­tur­ers,” the CBO said in 2007.

That same year, the House ac­tu­al­ly passed for­mer Michi­gan Rep. John Din­gell’s Medicare Pre­scrip­tion Drug Price Ne­go­ti­a­tion Act of 2007, which would’ve re­versed the ear­li­er law and al­lowed the HHS sec­re­tary to ne­go­ti­ate Part D prices with phar­ma­ceu­ti­cal man­u­fac­tur­ers, in­clud­ing on dis­counts, re­bates and oth­er price con­ces­sions. The vote was 255 to 170 in fa­vor, with 24 Re­pub­li­cans join­ing 231 De­moc­rats in ap­prov­ing the bill.

But for­mer Pres­i­dent George W. Bush threat­ened a ve­to, his HHS sec­re­tary said he wouldn’t even ne­go­ti­ate if he had the pow­er, and on the Sen­ate side, as the New York Times ex­plained, the De­moc­rats “could not muster the 60 votes need­ed to take up the leg­is­la­tion in the face of staunch op­po­si­tion from Re­pub­li­cans, who said that pri­vate in­sur­ers and their agents, known as phar­ma­cy ben­e­fit man­agers, were al­ready ne­go­ti­at­ing large dis­counts for Medicare ben­e­fi­cia­ries.”

Three years lat­er, Ver­mont De­mo­c­rat Pe­ter Welch and 61 of his peers in the House in­tro­duced the Medicare Pre­scrip­tion Drug Price Ne­go­ti­a­tion Act of 2010, with pro­ject­ed sav­ings of more than $150 bil­lion over 10 years. While the bill failed to pass, Welch has been at the fore­front of drug price ne­go­ti­a­tion bills, spon­sor­ing or co-spon­sor­ing mul­ti­ple drug price ne­go­ti­a­tion bills over the last decade.

Welch al­so worked with Reps. Lloyd Doggett and civ­il rights ad­vo­cate Eli­jah Cum­mings to in­tro­duce The Medicare Ne­go­ti­a­tion and Com­pet­i­tive Li­cens­ing Act of 2019. As House Over­sight com­mit­tee chair, Cum­mings put a lot of time and ef­fort in­to go­ing af­ter egre­gious phar­ma com­pa­nies, in­ves­ti­gat­ing mas­sive price spikes from the likes of the now-im­pris­oned Mar­tin Shkre­li in 2016 (al­though not as a re­sult of the Over­sight in­ves­ti­ga­tion), Bio­gen’s MS drug (see Tweet be­low), and the in­fa­mous Valeant Phar­ma­ceu­ti­cals back in 2015.

But the whack-a-mole ap­proach to com­bat­ing overnight drug price spikes has not re­sult­ed in sub­stan­tial sav­ings na­tion­wide.

In 2019, the same year Cum­mings died, Pelosi was able to pull to­geth­er enough votes to pass her Medicare price ne­go­ti­a­tion bill, named in hon­or of Cum­mings as the Eli­jah E. Cum­mings Low­er Drug Costs Now Act. The bill passed by a vote of 230 to 192, with an even slim­mer mar­gin than Din­gell’s bill. Again, how­ev­er, the Re­pub­li­can-con­trolled Sen­ate failed to take up Pelosi’s bill.

This year, Pelosi’s bill has been float­ed as an out­line for Sen­ate De­moc­rats’ di­rec­tion. Re­pub­li­cans al­so may be keen to build off the over­whelm­ing pub­lic sup­port for crack­ing down on drug prices. A West Health/Gallup sur­vey of more than 3,700 adults from June found near­ly all De­moc­rats (97%), In­de­pen­dents (80%), and the ma­jor­i­ty of Re­pub­li­cans (61%) sup­port em­pow­er­ing the fed­er­al gov­ern­ment to ne­go­ti­ate low­er prices of brand-name pre­scrip­tion drugs cov­ered by Medicare.

But lob­by­ing groups like PhRMA are des­per­ate­ly try­ing to re-frame the con­ver­sa­tion, buy­ing up ads to dri­ve away sup­port for any bill that in­cludes Medicare ne­go­ti­a­tions.

“They call it ne­go­ti­a­tion, but it re­al­ly means the gov­ern­ment de­cides what med­i­cines I can get,” a woman named Sue with type 1 di­a­betes said in a re­cent PhRMA ad at­tack­ing the pric­ing leg­is­la­tion.

De­moc­rats have trou­ble brew­ing among some of their own ranks too, as New Jer­sey Sen. Bob Menen­dez, whose dis­trict in­cludes bio­phar­ma com­pa­nies, said in Ju­ly that he had reser­va­tions about al­low­ing Medicare to ne­go­ti­ate. Ari­zona Sen. Kyrsten Sine­ma al­so has been show­ered with phar­ma dol­lars.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

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