Sen­a­tor Wyden prods Trump/Pfiz­er for de­tails, call­ing drug pric­ing stunt 'long on the­atrics, short on re­lief'

Sen­a­tor Ron Wyden (D-Ore­gon) on Wednes­day sought more de­tails from Pres­i­dent Don­ald Trump’s HHS Sec­re­tary and Pfiz­er on the com­pa­ny’s de­ci­sion to de­lay price in­creas­es.

Ron Wyden

In a let­ter to Pfiz­er, Wyden said, “Rolling back pre­vi­ous­ly an­nounced price in­creas­es based on a con­ver­sa­tion with the Pres­i­dent il­lus­trates how ar­bi­trary drug man­u­fac­tur­ers’ de­ci­sions to in­crease prices [are].”

Ac­cord­ing to mul­ti­ple re­ports, Pfiz­er raised the prices of about 100 prod­ucts as of Ju­ly 1, but on Tues­day said those hikes would be de­layed un­til Trump’s drug price blue­print comes in­to force — rais­ing ques­tions about what would be im­ple­ment­ed that would cause Pfiz­er to make an about face on the hikes.

At a Pew Re­search event Tues­day, HHS’ deputy as­sis­tant sec­re­tary for plan­ning and eval­u­a­tion John O’Brien de­clined to com­ment on what could be im­ple­ment­ed or what such a time­line might look like for the drug pric­ing blue­print to come in­to force.

Wyden, how­ev­er, wants to know what the ad­min­is­tra­tion agreed to in ex­change for Pfiz­er’s de­ci­sion to de­lay the price in­creas­es, and he al­so wants the date by which Pfiz­er could re­turn to the price in­creas­es.

And in a let­ter to HHS Sec­re­tary Alex Azar, Wyden ques­tioned the lo­gis­tics of what Pfiz­er an­nounced.

“Like many pro­nounce­ments com­ing out of the Ad­min­is­tra­tion, the Pres­i­dent’s agree­ment with Pfiz­er is long on the­atrics and short on re­al and sus­tain­able re­lief for pa­tients be­ing mugged at the phar­ma­cy counter,” Wyden wrote to Azar.

Pfiz­er di­rect­ed us to its com­ment from Tues­day evening.

New Bill

Mean­while, Mass­a­chu­setts sen­a­tor Eliz­a­beth War­ren and sev­er­al oth­er Sen­ate De­moc­rats in­tro­duced a bill on Wednes­day to cap pre­scrip­tion drug co­pays.

The bill would cap pre­scrip­tion drug co­pays at $250 per month for in­di­vid­u­als and $500 per month for fam­i­lies. The caps would ap­ply to both group health plans and in­di­vid­ual mar­ket plans.


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. 

Author

Zachary Brennan

managing editor, RAPS

Brent Saunders [Getty Photos]

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Novavax site in Gaithersburg, MD. Novavax

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With an $18 mil­lion pay­ment, Paragon is tak­ing over two No­vavax sites in Gaithers­burg, MD, in­clud­ing more than 100 of the em­ploy­ees al­ready work­ing there. That’s in ad­di­tion to a sig­nif­i­cant re­duc­tion in op­er­at­ing costs, says the com­pa­ny, as No­vavax shifts to re­ly on Paragon for GMP ma­te­ri­als in clin­i­cal tri­als and, even­tu­al­ly, com­mer­cial sup­ply of their prod­ucts.

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Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

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As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

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This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

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An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Novotech CEO Dr. John Moller

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Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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