Drug prices in ads: Sen­ate pass­es amend­ment

The Sen­ate spend­ing bill passed Thurs­day and with it an amend­ment from Sens. Richard Durbin (D-IL) and Chuck Grass­ley (R-IA) to re­quire pre­scrip­tion drug ad­ver­tise­ments to in­clude prices.

Richard Durbin

The move, part of an ef­fort to shine a light on phar­ma­ceu­ti­cal com­pa­nies’ high drug prices, pro­vides the US De­part­ment of Health and Hu­man Ser­vices (HHS) with $1 mil­lion to im­ple­ment rules re­quir­ing phar­ma­ceu­ti­cal com­pa­nies to list prices of their pre­scrip­tion drugs in di­rect-to-con­sumer (DTC) ad­ver­tise­ments.

Last year, the phar­ma­ceu­ti­cal in­dus­try spent more than $6 bil­lion in DTC ad­ver­tise­ments, and the av­er­age Amer­i­can sees nine DTC pre­scrip­tion drug ads each day, ac­cord­ing to Grass­ley. The text of the amend­ment reads: “A drug that is ad­ver­tised to con­sumers with­out the in­for­ma­tion re­quired by this sec­tion or its im­ple­ment­ing reg­u­la­tions shall be deemed to be mis­brand­ed.”

Chuck Grass­ley

Durbin, who not­ed phar­ma­ceu­ti­cal com­pa­nies were the on­ly ones op­posed to the amend­ment, said in a state­ment: “What Sen­a­tor Grass­ley and I want­ed to do is to give the Amer­i­can peo­ple more in­for­ma­tion about drug costs. More in­for­ma­tion gives trans­paren­cy to the trans­ac­tion, and will help give Amer­i­can con­sumers a break and start to slow down the sky­rock­et­ing cost of pre­scrip­tion drugs.”

But whether the prices in ads will fur­ther en­rage or con­fuse Amer­i­cans re­mains to be seen. Sim­i­lar­ly, whether com­pa­nies will de­cide to ad­ver­tise dif­fer­ent prod­ucts based on price re­mains to be seen. The spon­sors of the amend­ment have yet to say whether the ads will use list prices or re­bate-re­duced prices, but they have linked their amend­ment to a new­ly pro­posed rule­mak­ing on trans­paren­cy.

Ear­li­er this week, the Cen­ters for Medicare and Med­ic­aid Ser­vices (CMS) sent for re­view a pro­posed rule­mak­ing ti­tled “Reg­u­la­tion to Re­quire Drug Pric­ing Trans­paren­cy” — though the text of the rule­mak­ing has not been made pub­lic. CMS cur­rent­ly of­fers drug spend­ing dash­boards, with in­for­ma­tion on Medicare Part B and D pro­grams as well as Med­ic­aid.

Ear­li­er this month, CMS al­so an­nounced plans to be­gin us­ing what’s called step ther­a­py to try to low­er the spend on Part B drugs by about 20% in Medicare Ad­van­tage plans. The an­nounce­ments are be­gin­ning to add up to a wider ef­fort, in­clud­ing the FDA’s gener­ic drug ap­provals, to bring down the prices of phar­ma­ceu­ti­cals. But whether the moves ac­tu­al­ly bring down prices re­mains to be seen.

Rachel Sachs, an as­sis­tant pro­fes­sor of law at Wash­ing­ton Uni­ver­si­ty in St. Louis, told Fo­cus: “Sec­re­tary Azar has de­cried the use of po­lit­i­cal ‘gim­micks’ that wouldn’t have an ef­fect on the prob­lem, but the ad­min­is­tra­tion has not yet ex­plained pub­licly how they think in­clud­ing prices in di­rect-to-con­sumer ad­ver­tise­ments will lead to drug com­pa­nies choos­ing to low­er their prices.”


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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

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The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.