Lawmakers’ Letter to Department of Commerce Misunderstands the NIST March-In ‘Framework’ and Comments

“Five of the eight NIST ‘scenarios’ did not address drugs or pharmaceuticals. As such, it is critically important to take all technologies into account in considering the effects of the Framework on commerce and innovation.”

NISTLast Wednesday, May 29, Senator Elizabeth Warren (D-MA) and Representative Lloyd Doggett (D-TX) jointly called on the Secretary and Under Secretary of the U.S. Department of Commerce to expedite the finalization of a federal proposal aimed at enabling the government to acquire “taxpayer-funded” patents and license them to competitors, which would theoretically result in cheaper products and services. The congress members argued that the proposed “framework” would play a pivotal role in mitigating the exorbitant costs associated with prescription drugs.

The federal proposal, titled “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights,” was published by the National Institute of Standards and Technology (NIST) for public comments on December 8, 2023. The proposed Framework is an analysis intended to operate within the parameters of the “march-in” provisions of the 1980 Bayh-Dole Act, which define the circumstances under which the government should mandate a license of a federally-funded patent to another party. The Framework proposes taking into account – for the first time in the history of the Act – the pricing of commercial goods and services resulting from the invention, and related cost considerations. About 52,000 comments were submitted.

In their May 29 letter, the lawmakers asserted that 85% of the public comments, about 43,000, favored the outlined Framework ([t]housands of Americans, … have stated loudly and clearly that they support the administration’s proposed framework”). (An example of the 10 quotes included in the letter recites, e.g., “I support the use of march-in authority to lower prescription drug prices.”)  The authors emphasized that such widespread support signifies a strong endorsement for the Framework, intended to ensure affordable drugs.

Mass Replication Doesn’t Signal Widespread Support

I transmitted a responsive letter to the Secretary of Commerce on May 31. In it I pointed out that my research on the submitted comments reflected that about 86% were replicates, either computer generated or the product of mass mailing form letters.

In addition, the authors’ search algorithm (defined in footnote 4) was directed solely to results supporting lower prescription drug pricing, just as is every example they quote, and it looks like the same search I performed to establish the outrageous number of replicates and presumption of mass-mailing or computer generation. The NIST Framework is intended to be applied by funding agencies much more broadly, to every technology supported by federal funding – five of the eight NIST “scenarios” did not address drugs or pharmaceuticals. As such, it is critically important to take all technologies into account in considering the effects of the Framework on commerce and innovation.

Further, not a single quoted comment identifies the proposed Framework analysis as a source of the benefit – they all simply want the government to mandate lower drug prices.

Moreover, whoever provided the language of the replicate submissions did not incorporate an understanding that the Framework is distinct and different from the march-in right itself, and the submitters only request or demand “march-in rights” or “march-in authority” (check out the replicate language). Nobody asserts that prescription drugs aren’t often expensive, which reduces affordability, but the quoted comments are specifically not “in favor of” the Framework at all.

Where’s the Evidence?

Regarding the conclusion of the lawmakers’ letter, they fail to mention that there is no evidence that the application of the Framework would lower drug pricing. When this exact same provision was first proposed in 2021, there was general agreement, including by the sitting President, that it would not lower drug prices. No evidence has come to light that contradicts this position.

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Join the Discussion

4 comments so far. Add my comment.

  • [Avatar for xtian]
    June 10, 2024 10:54 am

    Those in the investment community will actively seek to avoid any pharma/biotech where patents were a result of NIH finding (thereby falling within Bayh-Dole), and by consequence, the pharma/biotechs will actively avoid university research funded by NIH grants.

    This mean’s less sponsored research agreements for Universities – less money – less commercialization of the research funded by NIH grants. The exact opposite of why Bayh-Dole was enacted.

  • [Avatar for Charles E. Miller, Association of Amicus Counsel]
    Charles E. Miller, Association of Amicus Counsel
    June 8, 2024 04:20 pm

    The author has done a public service by exposing a tactic being used by some officials aimed at reaching the goal of leading the nation down the slippery slope toward government price controls, not just in federally (taxpayer) – funded pharmaceutical inventions, not just in federally-funded inventions generally (as if those weren’t bad enough), but also ultimately in the pricing of goods and services across-the-board, all in the name of ‘consumer protection.’

  • [Avatar for Moocow]
    June 7, 2024 01:18 pm

    On further inspection of NIST’s docket, it looks like almost all of the mass e-mailed duplicate submissions were received between late December 2023 and early February 2024, but were not posted until much later. For weeks, NIST apparently held on to these tens of thousands of submissions without posting any. Then, beginning around February 26, NIST started to post a trickle of these repetitive mass comments per day. And then apparently some decision was made to just publish them all by the tens of thousands on March 2, 4, and 6 in a huge docket dump.
    So in other words, it looks like NIST had over 40,000 mass-mailed duplicate comments in its in-box for 1-2 months without posting them. This would be in keeping with a normal policy of holding back mass-generated repetitive comments. Then, at the very end of the comment period, these mass comments (which had been received 1-2 months earlier) were all posted to the docket at once.
    Why would NIST at first NOT release these comments for weeks and months, but then reverse course and just post them all in a big bolus at the end? At some point a decision must have been made to deviate from normal policy and allow this docket to be swamped with mass e-mails “supporting” the framework.

  • [Avatar for Pro Say]
    Pro Say
    June 6, 2024 08:09 pm

    The Socialists Warren and Doggett need to tell the residents of their respective states that at least 10’s of 1,000’s of them will needlessly die in the years to come when the new life-saving medicines which would have otherwise become available to them . . . don’t.

    Also meaning it would be a great time to invest in cemeteries.

    Because they’re going to need them.

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