Massive Replication of Comments Submitted to NIST March-In Rights RFI Should Cause Concern

I have been critical of certain National Institute of Standards and Technology (NIST) proposals to alter the regulations related to the Bayh-Dole Act, in 2021 (Notice of Proposed Rulemaking, NPR), and specifically, the NIST “Framework” published for comments in December, 2023. My Comments submitted in February addressed numerous legal infirmities, ranging from construction analysis to demonstrated ambiguity problems of the Request for Information/Comments (RFI) itself.

A major issue that has only come to light after the closing of the Comments period on February 6, 2024, is that of the approximately 52,000 Comments posted on NIST’s website, about 45,200 are replicates, and that there are additional submission problems, including numerous identical submissions by the same person, and comments submitted from at least one foreign country with no representation that the submitters are American or would be subject to any future action within the scope of the “Framework.”

The Comments posted on the NIST website are searchable, which makes it possible to discover replicates after they are identified.  I uncovered about 42,000 replicates of one Comment (in favor of the RFI), and there are about 3,200 replicates of another (critical of the RFI).

The most widely copied comment (in favor of the NIST proposal) is:

“I support the use of march-in authority to lower prescription drug prices.

Americans shouldn’t pay the highest prices in the world for medicines that were developed with our tax dollars. The final guidelines must also ensure that the vast majority of drugs, which are already priced at egregious levels, will be included as candidates for use of march-in rights. We need these guidelines to be iron-clad and bring down the exorbitant prices of prescription drugs!”

E.g., NIST-2023-0008-38009. There are some variants to this prototype. As of March 26, 2024, the “I support” sentence is repeated 42,753 times; “Americans shouldn’t pay …” repeated  42,208 times; “The final guidelines must also ensure” … repeated 42,205 times; and “We need these guidelines …” repeated 42,320 times.

Another comment widely replicated (against the NIST proposal) is:

“Maryland is a national leader in biopharmaceutical innovation, leading the country in the development of new treatments to treat many chronic and debilitating conditions. Our ability to develop and bring new medications to market is due, in part, to the incentivization of public and private partnerships and the protection of strong intellectual property (IP) rights.

Our current IP system is the foundation for new treatments and cures. However, the Biden administration’s recently released guidelines around the use of march-in; rights will decimate our local innovation ecosystem in Maryland – as well as our national ability – to develop new medications, respond to public health threats, and excel in biomedical innovation. March-in rights are intended to only be used in four specific circumstances and the National Institutes of Health (NIH) has historically denied every march-in request because the correct circumstances have never been met. Misusing march-in rights will have little to no impact on the cost of medicines, and will only hold back critical research and development for treatments that patients are waiting for.

Please protect our nation’s ability to bring new treatments and cures from a research lab to a patient’s medicine cabinet. Weakening IP rights is a misguided attempt to lower health care costs for patients. Take action to protect patients, public and private partnerships, and our nation’s leading life sciences industry.”

E.g., NIST-2023-0008-6141. There could certainly be additional, different comments that are replicates of which I am not aware.

In addition to replicate comments, I uncovered

• replicate Comments submitted by six persons – and again, there could be others, many others [gov ; Regulations.gov ; Regulations.gov ; Regulations.gov ; Regulations.gov ; Regulations.gov];
• 12 identical Comments submitted under two different slightly-differently spelled names using the same email address [gov and Regulations.gov]; and also
• 11 Comments purporting to be from the same town in England (Preston), 10 of which were the same person, and none of which stated a relationship with the United States [gov].

There is no way for me to know how many more replicates exist.

The NIST website links to FAQs stating that not every comment may be posted, including those that reflect “duplicate/near duplicate examples of a mass-mail campaign,” so it appears that NIST has chosen to post duplicates and near duplicates in disregard of this prohibition.

But of course, the problem with 86% replicates of all comments is not that they were posted, but the likelihood that NIST and the administration will consider them as if they were not “examples of a mass-mail campaign” in determining how to address the “Framework.” I fear that NIST will consider that the 80% of the replicate comments in favor of the Framework (or more accurately, in favor of lower drug prices) to be truly representative of 42,000 concerned Americans (if indeed submitted by real persons), and the same with the 5.8% critical of the Framework and 3,200 concerned Americans.

With large-scale computers presumably at work, it is disturbing to believe that NIST has willingly permitted submitters to “stuff the ballot box.”

Image Source: Deposit Photos
Author: ashumskiy
Image ID: 33875487