Re­pub­li­cans un­veil a drug price bill to ri­val the De­moc­rats — promis­ing low­er prices and more cures

Nan­cy Pelosi un­veiled the De­moc­rats’  drug pric­ing bill back in Sep­tem­ber and brought the fight straight to the in­dus­try with a pro­pos­al to em­pow­er the US gov­ern­ment to ne­go­ti­ate prices for se­lect drugs. Re­pub­li­cans, who de­cried the bill reeks of heavy-hand­ed gov­ern­ment in­ter­ven­tion which will sti­fle in­no­va­tion, now have a coun­ter­pro­pos­al they claim will re­sult in cheap­er drugs and in­cen­tivize R&D — fur­ther cloud­ing the prospects of a bi­par­ti­san com­pro­mise that could land on Don­ald Trump’s desk.

“On­ly one of these bills has the po­ten­tial to be­come law. While Speak­er Pelosi’s par­ti­san plan is dead on ar­rival in the Sen­ate and won’t be signed by Pres­i­dent Trump, H.R. 19 could be on Pres­i­dent Trump’s desk to­day,” said Re­pub­li­can Whip Steve Scalise in a state­ment on Mon­day. And in an ac­knowl­edg­ment that the Re­pub­li­can ef­fort would need Pelosi’s sign-off to reach a vote — a high­ly un­like­ly event — Scalise con­tin­ued, “Speak­er Pelosi must come to her sens­es. I am call­ing on her to bring H.R. 19 to the House floor for a vote this week. Amer­i­cans need a bi­par­ti­san so­lu­tion to pre­scrip­tion drug prices, not an­oth­er doomed pro­pos­al from the De­moc­rats.”

Re­pub­li­cans and De­moc­rats both ar­gue drug prices in the Unit­ed States are too high — the in­dus­try holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self — but so far no­body can agree on just how to make the US health care sys­tem great again.

The 350-page Re­pub­li­can bill, HR19, pro­pos­es cre­at­ing the role of a ‘chief phar­ma­ceu­ti­cal ne­go­tia­tor’ at the Of­fice of the Unit­ed States Trade Rep­re­sen­ta­tive to ad­vo­cate on be­half of Amer­i­can pa­tients in trade agree­ments with re­spect to pre­scrip­tion drug prices.

In ad­di­tion, the bill seeks to lim­it an­nu­al out-of-pock­et costs for Medicare ben­e­fi­cia­ries at $3,100; caps the cost of in­sulin for se­niors in the Medicare Part D pro­gram; re­quires in­sur­ance com­pa­nies to make in­for­ma­tion about drug prices trans­par­ent at doc­tor’s of­fices so pa­tients are ap­prised of the po­ten­tial costs be­fore a pre­scrip­tion is writ­ten; and ‘stream­lines’ the reg­u­la­tion of over-the-counter prod­ucts.

Some of the pro­pos­als in HR19 al­so mir­ror poli­cies ad­vo­cat­ed by bi­par­ti­san leg­is­la­tion cur­rent­ly un­der con­sid­er­a­tion in the Sen­ate, in­clud­ing the CRE­ATES act which is de­signed to en­sure gener­ic drug­mak­ers can ac­cess brand­ed drugs to de­vel­op copy­cats, and pro­hibits “pay-for-de­lay” deals, where man­u­fac­tur­ers of brand­ed drugs main­tain their mo­nop­o­lies by of­fer­ing gener­ic com­pa­nies re­wards for de­lay­ing the launch of knock­off prod­ucts. 

The De­moc­rats’ drug pric­ing bill — HR 3, which is set to face a vote this week — could com­pel man­u­fac­tur­ers to com­ply with the prices set by the HHS, or face grave penal­ties and teth­ers the price of the some of the na­tion’s most ex­pen­sive drugs to an in­ter­na­tion­al price in­dex. Un­sur­pris­ing­ly, the bill — which promis­es to cut fed­er­al spend­ing by $345 bil­lion be­tween 2023 and 2029 — elicit­ed the ire of the in­dus­try that has so far thrived by tak­ing a lais­sez-faire ap­proach to pric­ing. Var­i­ous analy­ses have sug­gest­ed the bill, which is un­like­ly to be signed in­to law, could re­sult in be­tween 8 to 100 few­er drugs from reach­ing the mar­ket over the next decade.

A raft of Re­pub­li­can law­mak­ers is­sued state­ments sup­port­ing HR19 on Mon­day, sug­gest­ing not on­ly is HR19 su­pe­ri­or to HR3, but is far more like­ly to be signed in­to law.

“This (bill) con­tains mea­sures with bi­par­ti­san sup­port in the House and Sen­ate, can be­come law, and de­serves a vote. Mean­while, Speak­er Pelosi’s par­ti­san drug pric­ing scheme is not on­ly bad pol­i­cy, it’s nev­er go­ing to be­come law,” said the ar­chi­tects of HR19, Kevin Brady, the se­nior Re­pub­li­can on the pow­er­ful Ways and Means Com­mit­tee, along with Greg Walden (R-OR) and Vir­ginia Foxx (R-NC).

That may well be the case — the White House last week is­sued a scathing re­view of HR3, ac­cus­ing the Pelosi bill of fa­vor­ing short-term sav­ings over the “long-term cost of Amer­i­can pa­tients los­ing ac­cess to new life­sav­ing treat­ments.” But with De­moc­rats firm­ly in charge of the House of Rep­re­sen­ta­tives, HR19 faces a sim­i­lar­ly quixot­ic road to Trump’s desk, with ar­ti­cles of im­peach­ment threat­en­ing to over­shad­ow the po­lit­i­cal cal­en­dar.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.