Joe Biden on the North Lawn of the White House, April 27, 2020 (Evan Vucci/AP Images)

Opin­ion: Mean­ing­ful drug pric­ing re­forms are head­ed nowhere fast

Pres­i­dent Biden is tak­ing a page out of for­mer Pres­i­dent Trump’s drug pric­ing play­book: of­fer big promis­es around tough ne­go­ti­a­tions with drug­mak­ers, but fail to of­fer a vi­able path for get­ting it done.

Warn­ing signs that drug pric­ing would no longer be a pri­or­i­ty for the pres­i­dent’s mar­quee leg­is­la­tion came over the past week from the Wash­ing­ton Post and Wall Street Jour­nal. To the cha­grin of House Speak­er Nan­cy Pelosi (D-CA) and oth­er De­moc­rats, Pres­i­dent Biden’s mas­sive, $1.8 tril­lion so­cial safe­ty net plan to help Amer­i­can fam­i­lies, de­tails of which were un­veiled Wednes­day morn­ing, does not in­clude a ma­jor push to cur­tail drug prices.

Al­though Biden is sup­posed to of­fer more specifics in his speech to Con­gress tonight, in­clud­ing a de­mand for leg­is­la­tion on price ne­go­ti­a­tions this year, stand­alone leg­is­la­tion on ne­go­ti­a­tions is not like­ly to make head­way in the dead­locked Sen­ate, es­pe­cial­ly if it needs 60 votes for pas­sage.

Biden whiffed on an op­por­tu­ni­ty to spell out what he wants in writ­ing.

“Pres­i­dent Biden has a plan to build on the Af­ford­able Care Act and low­er pre­scrip­tion drug costs for every­one by let­ting Medicare ne­go­ti­ate prices,” the White House said Wednes­day. That was the on­ly men­tion of drug prices in the White House fact sheet on the safe­ty net over­haul.

Se­nior Biden of­fi­cials tried to down­play this gap­ing hole where Biden should ex­plain what he wants on drug prices, telling re­porters on a call on Tues­day evening that Biden “has been very, very clear that he re­mains ful­ly com­mit­ted to ne­go­ti­a­tions to re­duce pre­scrip­tion drug prices — that, you will hear him re­it­er­ate as a very top pri­or­i­ty and some­thing he deems ur­gent.”

But the broad­er nar­ra­tive is that drug pric­ing as a pri­or­i­ty is slip­ping, and no one knows why ex­act­ly, con­sid­er­ing the sup­port from House and Sen­ate De­moc­rats and even some Re­pub­li­cans. Per­haps the phar­ma­ceu­ti­cal lob­by has al­ready got­ten to Biden? Per­haps the Biden team doesn’t want to pun­ish drug­mak­ers af­ter how quick­ly they were able to de­vel­op Covid vac­cines?

What­ev­er the rea­son, those as­sur­ances from se­nior staffers mean very lit­tle as the House and Sen­ate re­main di­vid­ed on how to pur­sue drug prices. House De­moc­rats last week rein­tro­duced their land­mark (or dead in the wa­ter, de­pend­ing on which par­ty you lis­ten to) drug pric­ing bill, HR 3, which passed along par­ty lines in the House in De­cem­ber 2019 but was nev­er con­sid­ered by the Sen­ate.

At­tempts to re­vive that bill and oth­ers will be­gin in earnest next week at a House En­er­gy & Com­merce Com­mit­tee hear­ing. But if drug pric­ing leg­is­la­tion is re­al­ly go­ing to make head­way, the Sen­ate will need to weigh in.

Some Sen­ate Re­pub­li­cans have al­ready raised red flags about gov­ern­ment price ne­go­ti­a­tions (even as the US is the on­ly coun­try in the world to not ne­go­ti­ate) and fo­cused their plans in­stead on low­er­ing out-of-pock­et costs.

How the leg­is­la­tion makes it across the fin­ish line re­mains murky, but the need for such leg­is­la­tion is as clear as ever.

A new GAO analy­sis on Wednes­day found that for 20 brand-name drugs in 2020, es­ti­mat­ed US prices paid at the re­tail lev­el by con­sumers and oth­er pay­ers (such as in­sur­ers) were more than two to four times high­er than prices in Aus­tralia, Cana­da and France.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.