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.
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.