First, they heard noth­ing. Then, the NIH said in Jan­u­ary that they would hear some­thing in a month.

But now, that time­line has been ex­tend­ed even fur­ther out, per­haps due to the shock­waves that NIH would send to the bio­phar­ma in­dus­try if it de­cid­ed to use so-called “march-in” rights to low­er the price of a drug that still has patents pro­tect­ing its mo­nop­oly.

The lat­est cor­re­spon­dence from the NIH’s Of­fice of the Di­rec­tor, which is re­view­ing this pe­ti­tion and has de­nied past march-in re­quests, to Robert Sachs, one of the pe­ti­tion­ers and pa­tients with prostate can­cer who are seek­ing to bring down the price of Astel­las’ ex­pen­sive prostate can­cer drug Xtan­di, shows the NIH hasn’t even re­al­ly be­gun its re­view.

Blame it on Fran­cis Collins’ re­tire­ment? Let’s take a step back to show how this process has played out so far, af­ter this ini­tial word in Feb­ru­ary that a de­ci­sion might be im­mi­nent.

Ear­li­er this month, Sachs sent the fol­low­ing email to NIH re­gard­ing his and Clare Love’s pe­ti­tion, which if ap­proved, would be the first to use these so-called “march-in” rights to al­low the gov­ern­ment to break the patents on an ex­pen­sive drug and al­low for cheap­er ver­sions. His email to the act­ing deputy di­rec­tor of NIH and shared with End­points News:

On Jan­u­ary 10 (see be­low) you wrote to let us know that the NIH Of­fice of the Di­rec­tor’s re­view of our pe­ti­tion would like­ly take about a month. Since it’s now been al­most three months since you wrote, we want­ed to ask the cur­rent sta­tus of NIH’s re­view and when we may ex­pect a de­ci­sion on our re­quest for a march-in pro­ceed­ing to be ini­ti­at­ed and a fact-find­ing hear­ing held. We know that 37 CFR 401.6  gives Astel­las 30 days to re­spond to our pe­ti­tion so as­sume this has long since oc­curred. We al­so know that the reg­u­la­tions give the agency then 60 days to ini­ti­ate a march-in pro­ceed­ing or de­cline to pur­sue march-in rights fol­low­ing re­ceipt of Astel­las’s com­ments. (NIH has not re­quest­ed any ad­di­tion­al in­for­ma­tion from pe­ti­tion­ers.) So, to ask our ques­tion more pre­cise­ly, we’d ap­pre­ci­ate be­ing in­formed of where NIH’s re­view of our pe­ti­tion is on this time­line. Please in­clude this in­quiry in the record. Thank you again, Robert.

In re­sponse, last Tues­day at 5:09 PM, the NIH Ex­ec­u­tive Sec­re­tari­at wrote via email to Sachs that the re­view has hard­ly even be­gun, de­spite telling him in Jan­u­ary that the re­view would take one month:

Dear Robert Sachs,

I am writ­ing to ac­knowl­edge your April 5 email.

NIH is care­ful­ly re­view­ing the Xtan­di march-in pe­ti­tion to de­ter­mine whether the in­for­ma­tion re­ceived might war­rant the ex­er­cise of march-in rights, per 37 CFR 401.6. Ac­cord­ing­ly, the pe­ri­ods for re­sponse ref­er­enced in your let­ter have not yet been trig­gered. We will pro­vide a com­plete re­sponse once the re­view has been com­plet­ed and a de­ter­mi­na­tion is reached. Thank you for your un­der­stand­ing.

Sin­cere­ly,

Tara A. Schwetz, Ph.D.
Act­ing Prin­ci­pal Deputy Di­rec­tor, NIH

And on Wednes­day, Sachs said he sought to clar­i­fy what these pe­ri­ods are that need to be trig­gered, as­sum­ing that Schwetz meant that NIH was still await­ing a re­sponse from Astel­las. In a re­sponse email, he wrote:

If I read your email cor­rect­ly, NIH has yet to even ask Astel­las to re­spond to the in­for­ma­tion we’ve sub­mit­ted, trig­ger­ing the 30 day re­sponse pe­ri­od pro­vid­ed in 37 CFR Sec. 401.6. (If this is in­cor­rect please let me know.) Af­ter be­ing told by you on Jan­u­ary 10 that NIH’s re­view would like­ly take about a month, this de­lay is very dis­ap­point­ing to say the least.

So why does Sachs think there’s been such a de­lay to re­spond to his pe­ti­tion, which was ini­tial­ly sub­mit­ted last No­vem­ber? “I’d on­ly be spec­u­lat­ing,” he said. Part of the rea­son, at least for past march-in de­ci­sions, is that the NIH has ba­si­cal­ly called us­ing march-in an ex­treme mea­sure.

“The ex­tra­or­di­nary rem­e­dy of march-in is not an ap­pro­pri­ate means of con­trol­ling prices of drugs,” con­clud­ed the NIH for an Ab­b­Vie drug in 2013.

But some like Sen. Eliz­a­beth War­ren (D-MA) think it’s time for an ex­tra­or­di­nary mea­sure.

War­ren sent a let­ter to HHS Sec­re­tary Xavier Be­cer­ra call­ing on him to use his ex­ec­u­tive pow­ers to low­er drug prices and she men­tions the use of “march-in” rights. That let­ter came as an­oth­er let­ter from physi­cians and lawyers at Har­vard, Co­lum­bia and Yale sent to War­ren ex­plained how, “Based on the plain text of the statute, ex­ces­sive pric­ing alone should pro­vide suf­fi­cient grounds for ex­er­cis­ing march-in rights … There are strong in­di­ca­tions that the White House agrees that this ap­proach is le­gal.”

Should the NIH de­cide to ini­ti­ate a march-in pro­ceed­ing with Xtan­di, there may al­so be a hear­ing to dis­cuss it. Astel­las did not im­me­di­ate­ly re­spond to a re­quest for com­ment on whether the com­pa­ny has had a chance to re­view the pe­ti­tion.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.