HHS Secretary Xavier Becerra (AP Images)

'March-in' bat­tles heat up as non­prof­its pe­ti­tion HHS on 6 drugs as ear­li­er pe­ti­tion awaits de­ci­sion

Eight non­prof­its in­clud­ing Pub­lic Cit­i­zen and PrEP4All are pe­ti­tion­ing HHS Sec­re­tary Xavier Be­cer­ra to use con­tro­ver­sial “march-in” rights to low­er the prices of 6 drugs.

The idea be­hind the let­ter is cen­tered on the Bayh-Dole Act, which al­lows fed­er­al agen­cies to march-in on a fed­er­al­ly-fund­ed in­ven­tion when a rights hold­er fails to achieve “prac­ti­cal ap­pli­ca­tion” of the in­ven­tion, mean­ing that the rights hold­er fails to make the ben­e­fits of the in­ven­tion “avail­able to the pub­lic on rea­son­able terms.”

Such a move in the realm of drug prices has nev­er oc­curred be­fore, but sev­er­al high-pro­file De­moc­rats in re­cent months have sig­naled that it’s well with­in HHS’ le­gal bounds to get cre­ative in find­ing new ways to bring down drug prices. Re­pub­li­cans and phar­ma have de­rid­ed the idea as more of a cheap trick (NIH has nev­er agreed to use march-in) that would dis­cour­age R&D, and par­tic­u­lar­ly R&D on gov­ern­ment-fund­ed prod­ucts.

This lat­est pe­ti­tion re­leased Thurs­day tar­gets price re­duc­tions for Pfiz­er’s prostate can­cer drug Xtan­di ($129,000 per year) and its Covid-19 drug Paxlovid ($530 per 5-day course) which has been in short sup­ply, Gilead’s HIV drug De­scovy ($24,000 per year) and its he­pati­tis C drug Ep­clusa ($24,000 list price even with an au­tho­rized gener­ic), as well as in­halers and in­sulin, which are no­to­ri­ous­ly ex­pen­sive and dif­fi­cult to make gener­i­cal­ly.

Pe­ter De­Fazio

The pe­ti­tion builds on an ear­li­er pe­ti­tion from sev­er­al di­ag­nosed with prostate can­cer that is seek­ing to march-in to low­er Xtan­di’s price specif­i­cal­ly. NIH said yes­ter­day that it’s still re­view­ing that pe­ti­tion, al­though it pre­vi­ous­ly said it would com­plete its re­view by last month.

“We are cur­rent­ly re­view­ing the in­for­ma­tion sub­mit­ted in the 2021 pe­ti­tion to de­ter­mine whether the ini­ti­a­tion of the march-in pro­ce­dures out­lined in 37 CFR 401.6 may be war­rant­ed,” act­ing NIH di­rec­tor Lawrence Tabak said in a let­ter dat­ed March 24 to Rep. Pe­ter De­Fazio (D-OR).

Lloyd Doggett

Ear­ly last month, De­Fazio and Rep. Lloyd Doggett (D-TX) sent a let­ter to Be­cer­ra urg­ing him to use march-in to low­er these pre­scrip­tion drug costs. And this week’s pe­ti­tion­ers not­ed that the fed­er­al gov­ern­ment’s use of the law al­low­ing march-in oc­curred re­peat­ed­ly in the 1960s to buy low-cost gener­ic drugs.

But in­dus­try and oth­ers con­tin­ue to beat the drum over the wider ram­i­fi­ca­tions of such a move.

A lit­tle more than a week ago, near­ly 100 aca­d­e­mics, life sci­ence or­ga­ni­za­tions, lawyers and oth­ers sent a let­ter to Be­cer­ra call­ing on him to re­ject the pe­ti­tion, ex­plain­ing that march-in

was nev­er in­tend­ed as a means for the gov­ern­ment to im­pose ar­bi­trary price con­trols on re­sult­ing prod­ucts, as the NIH has con­clud­ed time and again. As then NIH Di­rec­tor Elias Zer­houni not­ed in 2004 while re­ject­ing the first march in pe­ti­tion seek­ing to im­pose price con­trols on a suc­cess­ful­ly com­mer­cial­ized prod­uct: ‘… the ex­tra­or­di­nary rem­e­dy of march-in rights is not anap­pro­pri­ate means of con­trol­ling prices.’ That was cor­rect then and re­mains so to­day.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.