Scoop: NIH re­sets the clock on Xtan­di 'march-in' pe­ti­tion re­quest from pa­tients with prostate can­cer

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.


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.

Illustration: Assistant Editor Kathy Wong for Endpoints News

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