US Capitol (Arsalan Arif for Endpoints News)

Vot­ers say Con­gress needs to curb drug prices. So why do the odds look grim for ma­jor leg­is­la­tion this year?

House De­moc­rats are poised to pass sweep­ing leg­is­la­tion to low­er drug prices us­ing strate­gies Pres­i­dent Don­ald Trump has en­dorsed. A Trump aide urged the Re­pub­li­can-con­trolled Sen­ate to vote on a dif­fer­ent pack­age curb­ing drug prices that was draft­ed by a se­nior Re­pub­li­can.

But at least right now, nei­ther mea­sure ap­pears like­ly to at­tract enough bi­par­ti­san sup­port to be­come law.

Near­ly 8 in 10 Amer­i­cans say the cost of pre­scrip­tion drugs is un­rea­son­able, with vot­ers from both par­ties agree­ing that re­duc­ing the cost of pre­scrip­tion drugs should be one of Con­gress’ top pri­or­i­ties, ac­cord­ing to a poll last month by the Kaiser Fam­i­ly Foun­da­tion. (KHN is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of the foun­da­tion.)

With such broad and bi­par­ti­san sup­port, why do the odds look grim for Con­gress to pass sig­nif­i­cant drug pric­ing leg­is­la­tion this year?

Be­cause whether it’s shar­ing the cred­it for a leg­isla­tive vic­to­ry with the oth­er par­ty or run­ning afoul of the pow­er­ful drug­mak­er lob­by, nei­ther De­moc­rats nor Re­pub­li­cans are sure the ben­e­fits are worth the risks, ac­cord­ing to sev­er­al of those fa­mil­iar with the de­bate on Capi­tol Hill.

Com­pli­ca­tions From ‘Medicare For All,’ Im­peach­ment

Sen­ate Ma­jor­i­ty Leader Mitch Mc­Connell, who is a Re­pub­li­can and con­trols what leg­is­la­tion gets to the Sen­ate floor, has said he will not al­low a vote on the House De­moc­rats’ leg­is­la­tion. Among oth­er things, the bill writ­ten by House Speak­er Nan­cy Pelosi and oth­er De­mo­c­ra­t­ic lead­ers would en­able fed­er­al health of­fi­cials to ne­go­ti­ate the prices of as many as 250 of the most cost­ly drugs. Al­though Trump has en­dorsed that tac­tic, most Re­pub­li­can law­mak­ers op­pose it be­cause they are philo­soph­i­cal­ly op­posed to in­ter­fer­ing with the mar­ket.

On Fri­day, Trump’s chief do­mes­tic pol­i­cy ad­vis­er, Joe Gro­gan, said any drug pric­ing leg­is­la­tion would need bi­par­ti­san sup­port, say­ing of Pelosi’s plan: “It is not go­ing to pass in its cur­rent form.” He said the White House sup­ports the bi­par­ti­san pack­age draft­ed by Sen. Chuck Grass­ley (R-Iowa), who chairs the Fi­nance Com­mit­tee, and the com­mit­tee’s top De­mo­c­rat, Sen. Ron Wyden of Ore­gon.

But many Sen­ate Re­pub­li­cans in par­tic­u­lar are un­com­fort­able with one of the bill’s key pro­vi­sions: a re­quire­ment that drug­mak­ers not raise their prices on drugs cov­ered by Medicare faster than the rate of in­fla­tion.

Asked whether the White House sup­ports the in­fla­tion caps, Gro­gan said they were “not the ad­min­is­tra­tion’s pro­pos­al, but they are the prod­uct of a bi­par­ti­san com­pro­mise, and they are the route to a bi­par­ti­san bill, in our opin­ion.”

In a re­cent in­ter­view, Grass­ley spokesman Michael Zona dis­missed the call from oth­er Re­pub­li­cans to elim­i­nate the pro­vi­sion. “There’s no need,” he said. “The bill passed with a bi­par­ti­san two-thirds ma­jor­i­ty in com­mit­tee, and sup­port’s grow­ing for the bill every week among Re­pub­li­cans.”

While the Sen­ate Fi­nance Com­mit­tee did vote 19-9 in Ju­ly to send the Grass­ley-Wyden bill to the full Sen­ate for con­sid­er­a­tion, some Re­pub­li­cans who vot­ed to ad­vance it cau­tioned then that they may not ul­ti­mate­ly vote for the bill.

While con­sid­er­ing the bill, all but two of the com­mit­tee’s Re­pub­li­can mem­bers vot­ed to kill the pro­vi­sion to pre­vent Medicare drug prices from ris­ing faster than in­fla­tion. Grass­ley, how­ev­er, got De­mo­c­ra­t­ic sup­port and it stayed in the bill.

But it’s not clear if the bill will come to the floor. Mc­Connell is known to be un­will­ing to cor­ner Sen­ate Re­pub­li­cans with votes that could be po­lit­i­cal­ly risky dur­ing cam­paign sea­son, whether due to crit­i­cism from De­moc­rats or pres­sure from the drug in­dus­try.

In ad­di­tion, the push by some pro­gres­sive De­mo­c­ra­t­ic pres­i­den­tial can­di­dates for a gov­ern­ment-con­trolled “Medicare for All” health sys­tem has not made it more ap­peal­ing for Re­pub­li­cans to work with De­moc­rats on health care is­sues, said Kim Monk, a health care an­a­lyst and part­ner at Cap­i­tal Al­pha Part­ners who used to work for Re­pub­li­cans in the Sen­ate.

“Why would Re­pub­li­cans stick their neck out while De­moc­rats are fight­ing over Medicare for All?” she asked.

And Sen­ate Mi­nor­i­ty Leader Chuck Schumer of New York, a De­mo­c­rat, has drawn a line in­sist­ing any health care leg­is­la­tion come with pro­tec­tions for those with pre­ex­ist­ing con­di­tions. That’s a risky con­ver­sa­tion for Re­pub­li­cans, be­cause a fed­er­al ap­peals court is con­sid­er­ing a law­suit brought by Re­pub­li­can states seek­ing to throw out the en­tire Af­ford­able Care Act, which guar­an­tees those with med­ical con­di­tions can get cov­er­age.

Still, polling sug­gests that the is­sue of drug pric­ing has the pow­er to mo­ti­vate vot­ers to sup­port one par­ty or the oth­er, and that is like­ly to mo­ti­vate law­mak­ers.

There are more Sen­ate Re­pub­li­can in­cum­bents up for re­elec­tion next year than De­moc­rats, and sev­er­al are con­sid­ered vul­ner­a­ble.

Mean­while, De­moc­rats might be able to ar­gue that they sought to tack­le the is­sue of prices, but Re­pub­li­cans backed away from it.

The de­ci­sion by House De­moc­rats last month to pur­sue an im­peach­ment in­quiry against Trump has no doubt poi­soned the wa­ters be­tween the par­ties. But the prospects have not looked promis­ing any­way for a com­pre­hen­sive, bi­par­ti­san pack­age of so­lu­tions to rein in es­ca­lat­ing drug costs.

A Third Leg­isla­tive Op­tion

Ac­knowl­edg­ing their prob­lems with the Pelosi and Grass­ley-Wyden pro­pos­als, some Re­pub­li­cans are tout­ing a mod­est mea­sure that has failed to be­come law in the three years since it was in­tro­duced: the CRE­ATES (Cre­at­ing and Restor­ing Equal Ac­cess To Equiv­a­lent Sam­ples) Act.

The CRE­ATES Act does not take a di­rect ap­proach to low­er­ing prices. Nonethe­less, based on po­lit­i­cal op­po­si­tion to the larg­er pack­ages, it could be some of the on­ly drug-pric­ing leg­is­la­tion that pass­es this Con­gress. The bill would crack down on tac­tics used by brand-name drug man­u­fac­tur­ers to dis­suade gener­ic com­peti­tors, aim­ing to elim­i­nate an­ti-com­pet­i­tive be­hav­ior and al­low the free mar­ket to bring down prices.

Specif­i­cal­ly, it would em­pow­er gener­ics man­u­fac­tur­ers to sue brand-name drug­mak­ers that block them from ob­tain­ing the sam­ples need­ed to con­duct stud­ies and get Food and Drug Ad­min­is­tra­tion ap­proval of their ver­sions. It would al­so give the FDA more lee­way to ap­prove al­ter­na­tive safe­ty pro­to­cols for high-risk drugs. Cur­rent­ly gener­ic drug­mak­ers are re­quired to join with the brand-name man­u­fac­tur­ers in a shared safe­ty sys­tem for those drugs, but some brand-name com­pa­nies refuse to ne­go­ti­ate with the gener­ic com­pa­nies, thus de­lay­ing their abil­i­ty to get FDA ap­proval.

It is the rare piece of leg­is­la­tion with sup­port from the likes of pro­gres­sive Sen. Shel­don White­house (D-R.I.) and con­ser­v­a­tive Sen. Mike Lee (R-Utah).

But the bill has hit snags be­fore. The brand-name drug in­dus­try trade group, the Phar­ma­ceu­ti­cal Re­search and Man­u­fac­tur­ers of Amer­i­ca, has op­posed the CRE­ATES Act in the past. With its heavy spend­ing on lob­by­ists, ad­ver­tise­ments and cam­paign con­tri­bu­tions for law­mak­ers, it has been a pow­er­ful op­po­nent.

Op­po­si­tion soft­ened ear­li­er this year, though, when ex­ec­u­tives from sev­en of the world’s biggest drug­mak­ers told the Sen­ate Fi­nance Com­mit­tee they are in fa­vor of the bill.

“We sup­port the over­all in­tent of the CRE­ATES Act,” Hol­ly Camp­bell, a PhRMA spokes­woman, said in an email. She added that drug­mak­ers “should not with­hold sam­ples with the in­tent of de­lay­ing gener­ic or biosim­i­lar en­try.”

Fac­ing the prospect that Con­gress could fail to pass big­ger fix­es like the Pelosi or Grass­ley-Wyden plans, some say CRE­ATES could be used to off­set the cost of health care pro­grams like com­mu­ni­ty health cen­ter fund­ing that will soon ex­pire if Con­gress does not ex­tend them.

In Ju­ly, the Con­gres­sion­al Bud­get Of­fice es­ti­mat­ed that the CRE­ATES Act could save the fed­er­al gov­ern­ment $3.7 bil­lion over 10 years.

But even some of CRE­ATES’ sup­port­ers say it is not enough to low­er drug prices.

“The idea that Con­gress is go­ing to low­er pre­scrip­tion drug prices with­out re­forms to Medicare is non­sen­si­cal,” said Zona, Grass­ley’s spokesman. He added that the CRE­ATES Act, which Grass­ley orig­i­nal­ly co-spon­sored, is im­por­tant. “But it’s on­ly one piece of the puz­zle.”

House mem­bers were home in their dis­tricts last week, and when they re­turn, they ex­pect to fo­cus on pass­ing spend­ing bills be­fore a Nov. 21 dead­line to ad­vert a gov­ern­ment shut­down, be­fore vot­ing on Pelosi’s plan.

In the mean­time, some are cau­tious in their pre­dic­tions about whether Con­gress can pass sig­nif­i­cant drug pric­ing leg­is­la­tion be­fore 2020, when the elec­tion cam­paign may prompt law­mak­ers to re­treat fur­ther in­to their re­spec­tive par­ti­san cor­ners.

Chip Davis, the chief ex­ec­u­tive of the gener­ic drug­mak­ers’ As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines, said that even though there is in­creas­ing agree­ment that the gov­ern­ment needs to act to help curb drug price in­creas­es, the two par­ties are ap­proach­ing it in very dis­tinct ways.

“It re­mains to be seen,” he added, “whether those dif­fer­ences of opin­ion can be rec­on­ciled in­to a pack­age that can get enough sup­port in both cham­bers.”

This sto­ry was orig­i­nal­ly pub­lished by Kaiser Health News, a na­tion­al health pol­i­cy news ser­vice. It is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of the Hen­ry J. Kaiser Fam­i­ly Foun­da­tion which is not af­fil­i­at­ed with Kaiser Per­ma­nente. Writ­ten by Em­marie Huet­te­man: ehuet­te­

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

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The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

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— NBC News, July 3

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So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

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So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

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