Fac­ing a deep­en­ing po­lit­i­cal cri­sis, PhRMA launch­es a ma­jor coun­ter­at­tack against its le­gion of crit­ics

Un­der the most heat­ed po­lit­i­cal at­tack the drug in­dus­try has ever faced on Capi­tol Hill, the lob­by­ing pow­er­house PhRMA is rolling out its most am­bi­tious pub­lic re­la­tions cam­paign in its his­to­ry.

Just months af­ter rais­ing dues to gen­er­ate an ex­tra $100 mil­lion for its war chest, PhRMA is re­port­ed­ly spend­ing tens of mil­lions of dol­lars on a new cam­paign aimed to win hearts and minds in the grow­ing bat­tle over drug prices. PhRMA’s cam­paign will ini­tial­ly hit hard on the sci­en­tif­ic ad­vances that are be­ing made, spot­light­ing big ad­vances in R&D to the gen­er­al pub­lic. And then they want to spon­sor more dis­cus­sions in pub­lic fo­rums while pur­su­ing their leg­isla­tive agen­da.

The cam­paign has been in the works for months now. But it comes just days af­ter Pres­i­dent Don­ald Trump went on a tirade against the in­dus­try, say­ing that drug mak­ers had been “get­ting away with mur­der” on pric­ing and vow­ing to rein in costs. Lat­er, Trump ex­plained that he planned to al­low Medicare to di­rect­ly ne­go­ti­ate drug prices for the first time, putting Big Phar­ma on no­tice that it would soon lose one of its most prized po­lit­i­cal ac­com­plish­ments.

Hillary Clin­ton had more crit­i­cisms for phar­ma dur­ing the pres­i­den­tial cam­paign, but Trump has made up on any lost ground, adopt­ing what is like­ly to be a wide­ly pop­u­lar stance on drug prices.

The most ex­plo­sive el­e­ment in drug prices, and the most po­tent po­lit­i­cal­ly, has fo­cused on com­pa­nies like Tur­ing, My­lan, Valeant and Mallinck­rodt, which all jacked the price on old meds, un­fet­tered by any laws or reg­u­la­tions that might pro­hib­it price goug­ing. But there has al­so been con­sid­er­able crit­i­cism of the in­dus­try’s wide­spread prac­tice of push­ing an­nu­al price hikes on their port­fo­lio drugs. And the price of many new drugs of­ten reach well in­to six fig­ures, adding to the gen­er­al dis­con­tent that could spawn leg­is­la­tion that would have a wide in­flu­ence on all bio­phar­ma com­pa­nies.

PhRMA CEO Stephen Ubl touched on the up­com­ing cam­paign at a pan­el dis­cus­sion I host­ed at JP Mor­gan a few weeks ago. He said:

At PhRMA and with­in the in­dus­try, we’re fo­cused on two things. First, we’re go­ing to launch a very am­bi­tious, com­pre­hen­sive, na­tion­al com­mu­ni­ca­tions and pub­lic af­fairs ef­fort. One com­po­nent will be ad­ver­tise­ments that are fo­cused on the ex­cit­ing break­throughs in sci­ence that we’ve not been, again, re­port­ing on in my view. But more im­por­tant­ly, it’s not just about ads. The ef­fort is go­ing to be putting the in­dus­try in a lead­er­ship role and con­ven­ing stake­hold­ers to talk about how we move the sys­tem from vol­ume to val­ue and what our role in that is. We need to come to the ta­ble with so­lu­tions, whether they’re FDA re­forms, bar­ri­ers to in­no­v­a­tive con­tract­ing, con­sumer-ori­ent­ed trans­paren­cy.

One of the ma­jor themes in this cam­paign is ex­pect­ed to be the ex­tra­or­di­nary cost in­volved in drug de­vel­op­ment as cheap gener­ics con­tin­ue to lim­it the amount of mon­ey spent on drugs in gen­er­al. Pfiz­er has tak­en that stance al­ready. But even with a high lev­el of bi­par­ti­san sup­port in Con­gress, ev­i­dent in the re­cent pas­sage of the 21st Cen­tu­ry Cures Act, PhRMA and phar­ma face a big and grow­ing deficit of pub­lic trust.

This new cam­paign is like­ly to elic­it com­par­isons to the “Har­ry and Louise” cam­paign that the health in­sur­ance lob­by used to help beat back threat­en­ing leg­is­la­tion. But it will come at many times the cost of that $20 mil­lion ef­fort.

Drug prices may ac­tu­al­ly on­ly ac­count for a frac­tion of the health­care dol­lar, but there’s no ques­tion it’s a high-pro­file item for the pub­lic. A few days ago The Har­ris Poll found that on­ly 9% of Amer­i­cans be­lieve that drug com­pa­nies put pa­tients ahead of prof­its.

That’s a dan­ger­ous­ly weak po­si­tion to be in.

“There are un­de­ni­able rep­u­ta­tion­al risks for phar­ma­ceu­ti­cal and health in­sur­ance com­pa­nies – more so than oth­er parts of the health care ecosys­tem,” said Wendy Sa­lomon, vice pres­i­dent of rep­u­ta­tion man­age­ment and pub­lic af­fairs at Nielsen. “Rep­u­ta­tion mat­ters to pa­tients, care providers, in­vestors, em­ploy­ees, and po­ten­tial hires. Pos­i­tive rep­u­ta­tions can pave the way in times of cri­sis, in times of tran­si­tion – and when it’s crit­i­cal to have a seat at the pol­i­cy-set­ting ta­ble.”


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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