Dems, Re­pub­li­cans split on 340B drug pric­ing pro­gram in Sen­ate hear­ing

The di­vid­ing line be­tween Sen­ate De­moc­rats and Re­pub­li­cans on the 340B drug pric­ing pro­gram was set on Thurs­day, with De­moc­rats sid­ing with the hos­pi­tals, say­ing the sav­ings from the pro­gram is des­per­ate­ly need­ed for the poor­est pop­u­la­tions, while Re­pub­li­cans took the side of drug­mak­ers, say­ing the pro­gram is be­ing abused and needs to be re­formed.

But the hear­ing al­so put the spot­light on the lack of trans­paren­cy from both the phar­ma­ceu­ti­cal and hos­pi­tal in­dus­tries, as nei­ther side could agree to some ba­sic sta­tis­tics, such as what per­cent of the to­tal drug spend in the US goes in­to the 340B pro­gram.

Lamar Alexan­der

For in­stance, the Health Re­sources & Ser­vices Ad­min­is­tra­tion, which over­sees the pro­gram, says that some­where be­tween 1% and 2% of the na­tion’s drug spend is at­trib­uted to the 340B pro­gram.

But Sen Lamar Alexan­der (R-TN) on Thurs­day ques­tioned what per­cent of what Amer­i­cans spend on pre­scrip­tion drugs is avail­able to safe­ty net hos­pi­tals and clin­ics for the pur­pos­es of 340B.

“Is it $6 bil­lion or $8 bil­lion or $14 bil­lion? If it’s 1 or 2%, well that’s just a tax on phar­ma­ceu­ti­cal com­pa­nies that we’re spend­ing for a good pur­pose, but if it’s 6% to 8%, then that’s a pret­ty big tax. I’d like to get those fig­ures,” Alexan­der said.

Lori Reil­ly

Lori Reil­ly, ex­ec­u­tive vice pres­i­dent of the lob­by­ing group PhRMA, told law­mak­ers that the to­tal spend on dis­counts by phar­ma­ceu­ti­cal com­pa­nies was $8 bil­lion in 2016, and that the to­tal 2016 spend on phar­ma­ceu­ti­cals in the US was “in the $390 bil­lion range,” though she could not con­firm an ex­act fig­ure to Alexan­der.

Sen Eliz­a­beth War­ren (D-MA), mean­while, said the size of the US drug mar­ket in 2015 was $457 bil­lion, while point­ing out that phar­ma­ceu­ti­cal com­pa­nies’ mar­gins were sig­nif­i­cant­ly high­er (she said six times as high) than hos­pi­tals’ mar­gins.

Eliz­a­beth War­ren

Pew Char­i­ta­ble Trusts, mean­while, re­cent­ly spot­light­ed the var­i­ous es­ti­mates and pro­jec­tions on drug spend­ing in the US, not­ing the dif­fer­ences among dif­fer­ent groups.

And though PhRMA’s Reil­ly said ear­li­er in the hear­ing that phar­ma­ceu­ti­cal com­pa­nies “do not want this pro­gram to dis­ap­pear,” War­ren took is­sue with PhRMA’s ar­gu­ment that the 340B rais­es drug prices.

“If 340B didn’t ex­ist, drug com­pa­nies would have an ex­tra $6 bil­lion in their pock­et, that’s less than 1% of glob­al phar­ma­ceu­ti­cal sales rev­enue,” War­ren said. “The loss that they’re kick­ing and scream­ing about is a tiny frac­tion of the many bil­lions of dol­lars they pull down every year in prof­its.”

Rep­re­sen­ta­tives of health cen­ters and hos­pi­tals, mean­while, not­ed that re­forms to low­er what drug­mak­ers spend on 340B dis­counts would hurt.

How­ev­er, re­form and more over­sight may still come.

study pub­lished in Health Af­fairs in 2014 found that 340B hos­pi­tals are ex­pand­ing their base in­to com­mu­ni­ties that tend to be af­flu­ent and well-in­sured, which runs counter to the ob­jec­tives of the pro­gram. The Al­liance for In­tegri­ty and Re­form of 340B, backed by the bio­phar­ma in­dus­try and oth­er groups, al­so re­leased a re­port that found in 2015, 61% of par­tic­i­pants spent less on char­i­ty care com­pared to both 2014 and 2013 de­spite ad­di­tion­al rev­enue re­ceived.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.