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“With large-scale computer systems presumably at work, it’s disturbing to imagine that NIST has willingly permitted submitters to ‘stuff the poll field.’”
I’ve been vital of sure Nationwide Institute of Requirements and Expertise (NIST) proposals to change the laws associated to the Bayh-Dole Act, in 2021 (Discover of Proposed Rulemaking, NPR), and particularly, the NIST “Framework” published for comments in December, 2023. My Comments submitted in February addressed quite a few authorized infirmities, starting from building evaluation to demonstrated ambiguity issues of the Request for Info/Feedback (RFI) itself.
A serious situation that has solely come to gentle after the closing of the Feedback interval on February 6, 2024, is that of the roughly 52,000 Feedback posted on NIST’s web site, about 45,200 are replicates, and that there are further submission issues, together with quite a few similar submissions by the identical particular person, and feedback submitted from no less than one overseas nation with no illustration that the submitters are American or can be topic to any future motion throughout the scope of the “Framework.”
The Comments posted on the NIST website are searchable, which makes it doable to find replicates after they’re recognized. I uncovered about 42,000 replicates of 1 Remark (in favor of the RFI), and there are about 3,200 replicates of one other (vital of the RFI).
Essentially the most broadly copied remark (in favor of the NIST proposal) is:
“I assist using march-in authority to decrease prescription drug costs.
People shouldn’t pay the very best costs on the planet for medicines that had been developed with our tax {dollars}. The ultimate tips should additionally be sure that the overwhelming majority of medicine, that are already priced at egregious ranges, will probably be included as candidates to be used of march-in rights. We want these tips to be iron-clad and convey down the exorbitant costs of pharmaceuticals!”
E.g., NIST-2023-0008-38009. There are some variants to this prototype. As of March 26, 2024, the “I assist” sentence is repeated 42,753 times; “People shouldn’t pay …” repeated 42,208 times; “The ultimate tips should additionally guarantee” … repeated 42,205 times; and “We want these tips …” repeated 42,320 times.
One other remark broadly replicated (in opposition to the NIST proposal) is:
“Maryland is a nationwide chief in biopharmaceutical innovation, main the nation within the improvement of latest remedies to deal with many power and debilitating situations. Our potential to develop and convey new medicines to market is due, partially, to the incentivization of private and non-private partnerships and the safety of robust mental property (IP) rights.
Our present IP system is the muse for brand spanking new remedies and cures. Nevertheless, the Biden administration’s just lately launched tips round using march-in; rights will decimate our native innovation ecosystem in Maryland – in addition to our nationwide potential – to develop new medicines, reply to public well being threats, and excel in biomedical innovation. March-in rights are supposed to solely be utilized in 4 particular circumstances and the Nationwide Institutes of Well being (NIH) has traditionally denied each march-in request as a result of the proper circumstances have by no means been met. Misusing march-in rights may have little to no affect on the price of medicines, and can solely maintain again vital analysis and improvement for remedies that sufferers are ready for.
Please shield our nation’s potential to deliver new remedies and cures from a analysis lab to a affected person’s medication cupboard. Weakening IP rights is a misguided try and decrease well being care prices for sufferers. Take motion to guard sufferers, private and non-private partnerships, and our nation’s main life sciences trade.”
E.g., NIST-2023-0008-6141. There might definitely be further, completely different feedback which can be replicates of which I’m not conscious.
Along with replicate feedback, I uncovered
- replicate Feedback submitted by six individuals – and once more, there could possibly be others, many others [gov ; Regulations.gov ; Regulations.gov ; Regulations.gov ; Regulations.gov ; Regulations.gov];
- 12 similar Feedback submitted below two completely different slightly-differently spelled names utilizing the identical electronic mail deal with [gov and Regulations.gov]; and in addition
- 11 Feedback purporting to be from the identical city in England (Preston), 10 of which had been the identical particular person, and none of which acknowledged a relationship with america [gov].
There isn’t any approach for me to know what number of extra replicates exist.
The NIST web site links to FAQs stating that not each remark could also be posted, together with people who mirror “duplicate/close to duplicate examples of a mass-mail marketing campaign,” so it seems that NIST has chosen to put up duplicates and close to duplicates in disregard of this prohibition.
However after all, the issue with 86% replicates of all feedback will not be that they had been posted, however the probability that NIST and the administration will think about them as in the event that they weren’t “examples of a mass-mail marketing campaign” in figuring out tips on how to deal with the “Framework.” I worry that NIST will think about that the 80% of the replicate feedback in favor of the Framework (or extra precisely, in favor of decrease drug costs) to be really consultant of 42,000 involved People (if certainly submitted by actual individuals), and the identical with the 5.8% vital of the Framework and three,200 involved People.
With large-scale computer systems presumably at work, it’s disturbing to imagine that NIST has willingly permitted submitters to “stuff the poll field.”
Picture Supply: Deposit Pictures
Writer: ashumskiy
Picture ID: 33875487
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