Donald Trump. Manuel Balce Ceneta, AP

Ex­ec­u­tive or­der un­der con­struc­tion to peg US drug prices to low­est prices abroad, Trump says

As he mounts his re-elec­tion bid for 2020, pres­i­dent Don­ald Trump un­veiled plans that an ex­ec­u­tive or­der is be­ing pre­pared to im­ple­ment a “fa­vored na­tions clause” to re­duce drug prices in the Unit­ed States, in con­ver­sa­tion with re­porters on the south lawn of the White House on Fri­day.

“We’re work­ing on a fa­vored na­tions clause, where we pay what­ev­er the low­est na­tion’s price is,” Trump said. “Why should oth­er na­tions — like Cana­da — why should oth­er na­tions pay less than us?”

Trump has long lam­bast­ed the phar­ma­ceu­ti­cal in­dus­try for its pric­ing poli­cies. Af­ter cap­tur­ing the pres­i­den­cy, Trump pro­claimed drug­mak­ers were “get­ting away with mur­der.” His ad­min­is­tra­tion has since un­veiled a string of pro­pos­als to tem­per pric­ing, in­clud­ing one last year en­gi­neered to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries. Whether this plan is the one he re­ferred to on Fri­day is un­clear.

The plan, de­signed to save Medicare more than $17 bil­lion over five years, was re­vealed in late Oc­to­ber ahead of a con­tentious mid-term bat­tle. The HHS out­lined an “in­ter­na­tion­al pric­ing in­dex (IPI)” in which prices for drugs uti­lized by Medicare — the world’s largest drug pur­chas­er — would be bench­marked against oth­er na­tions, in­stead of the way drugs are cur­rent­ly priced: by cal­cu­lat­ing the av­er­age sales price and adding 6% for the providers who man­age the drug sup­ply. Es­sen­tial­ly, in­stead of al­low­ing cheap­er drugs to be im­port­ed in­to the Unit­ed States, Trump’s ba­sic plan is to hold on to the drugs and im­port their prices.

Alex Azar HHS

This is a pi­lot pro­gram, how­ev­er, and is not be­ing primed for ex­e­cu­tion via an ex­ec­u­tive or­der. How­ev­er, to no­body’s sur­prise, the pro­pos­al elicit­ed the ire of the bio­phar­ma lob­by, and drug­mak­ers ar­gued that a num­ber of these na­tions do not ac­cept new med­i­cines due to their pric­ing poli­cies, of­ten re­strict­ing ac­cess or de­clin­ing to adopt them al­to­geth­er. An­oth­er is­sue is many drug­mak­ers aren’t par­tic­u­lar­ly forth­com­ing about the prices they set­tle on for their drugs fol­low­ing ne­go­ti­a­tions with for­eign gov­ern­ments.

A pro­pos­al re­quir­ing drug­mak­ers to di­vulge list prices in tele­vi­sion ads is set to go in­to ef­fect in the com­ing month, but many of the Trump ad­min­is­tra­tion’s oth­er drug price pro­pos­als are still be­ing ironed out.

On Ju­ly 1, HHS sec­re­tary and for­mer Eli Lil­ly ex­ec­u­tive Alex Azar sug­gest­ed the ad­min­is­tra­tion had set records by sav­ing pa­tients $26 bil­lion in gener­ic drug costs just the first year and a half of the pres­i­dent’s term. “We have al­so pro­posed that back­door re­bates in Medicare Part D, which amount­ed to $29 bil­lion last year, be de­liv­ered di­rect­ly as dis­counts to pa­tients at the phar­ma­cy counter — as soon as Jan. 1, 2020,” he wrote.

On Sat­ur­day, Trump de­clared he had gar­nered suc­cess in dri­ving down drug prices:

But the claim was read­i­ly dis­put­ed. Poli­ti­fact, owned by the non­prof­it Poyn­ter In­sti­tute for Me­dia Stud­ies, de­clared the claim “most­ly false,” cit­ing da­ta from the fed­er­al gov­ern­ment’s own data­base as well as an analy­sis pub­lished by the As­so­ci­at­ed Press in Sep­tem­ber that in­di­cat­ed that in the first nine months of 2018, there were 96 price in­creas­es for every price cut — al­though the rate of hikes is slow­ing.

Pres­i­den­tial hope­ful Bernie Sanders al­so chimed in:

Da­ta sug­gest that the Unit­ed States spends near­ly twice as much as 10 high-in­come coun­tries on health care — dri­ven by the high cost of la­bor and goods, in­clud­ing phar­ma­ceu­ti­cals and de­vices — but ac­tu­al­ly per­form worse on a num­ber of pop­u­la­tion health out­comes.

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 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.

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%.

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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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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