Durbin push­es for Sen­ate vote on bill to in­clude drug prices in ads

Sen­a­tor Richard Durbin (D-IL) took to the Sen­ate floor on Wednes­day to push for a vote on a bi­par­ti­san bill that would re­quire phar­ma­ceu­ti­cal com­pa­nies to list the prices of their pre­scrip­tion drugs in di­rect-to-con­sumer (DTC) ad­ver­tise­ments.

Ac­cord­ing to Durbin, the av­er­age Amer­i­can sees nine DTC drug ads each day and the phar­ma­ceu­ti­cal in­dus­try spends more than $6 bil­lion per year on DTC ads.

Durbin and Sen­a­tor Chuck Grass­ley (R-IA) passed a sim­i­lar ver­sion of this bill unan­i­mous­ly in the Sen­ate in Au­gust 2018, but it was re­moved in an ap­pro­pri­a­tions con­fer­ence with the House of Rep­re­sen­ta­tives.
Now, how­ev­er, Grass­ley notes that the De­moc­rats con­trol the House and if the Sen­ate acts on the bill, which is al­so co-spon­sored by Sen­a­tors An­gus King (I-ME), and Lamar Alexan­der (R-TN), it could be­come law.

The lat­est push for such dis­clo­sures comes as US Dis­trict Court Judge Amit Mehta in Ju­ly ruled that the US De­part­ment of Health and Hu­man Ser­vices (HHS) lacks the au­thor­i­ty to re­quire drug­mak­ers to post list prices in phar­ma­ceu­ti­cal DTC tele­vi­sion ad­ver­tise­ments.

Pre­vi­ous­ly in June, Am­gen, Mer­ck, Eli Lil­ly and the As­so­ci­a­tion of Na­tion­al Ad­ver­tis­ers sued HHS over its pend­ing rule that would have es­tab­lished such dis­clo­sures, claim­ing that the list prices are not what pa­tients pay and that the agency does not have the au­thor­i­ty for such a rule­mak­ing.

Mean­while, a re­search let­ter in JA­MA from Sep­tem­ber, shows how states are con­tin­u­ing to push for fur­ther drug price trans­paren­cy but with lit­tle suc­cess. Of 166 drug pric­ing laws iden­ti­fied in the study, 35 laws passed in 22 states and in­clud­ed a trans­paren­cy com­po­nent, but on­ly sev­en laws passed in six states were deemed in­for­ma­tive.

“De­spite many re­cent state laws about price trans­paren­cy, we found that most of them were in­suf­fi­cient to re­veal true trans­ac­tion prices, and no state passed leg­is­la­tion that pro­vid­ed ef­fec­tive trans­paren­cy across the en­tire sup­ply chain. To en­sure drug price leg­is­la­tion is use­ful, pol­i­cy mak­ers should re­quire that re­al price in­for­ma­tion, in­clud­ing dis­counts and re­bates, is re­port­ed by all sup­ply chain par­tic­i­pants,” the au­thors from the Uni­ver­si­ty of South­ern Cal­i­for­nia wrote.

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

So­cial im­age: Richard Durbin via durbin.sen­ate.gov


Zachary Brennan

managing editor, RAPS

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.