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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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