Why are the FDA and USPTO Ignoring Requests for Info on I-MAK?
“The question of drug pricing raises many complicated questions, and policy must be based on a true and accurate vision of the numerous complex underlying facts…. Although patents are an easy target, they are not the problem.”
Senator Thom Tillis (R-NC) has been unsuccessfully trying to obtain information from the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO) on data being used to support drug pricing proposals for nearly two and a half years. More specifically, in a January 31, 2022 letter, Senator Tillis requested an independent assessment and analysis of the sources of data that are being relied upon by those advocating for patent-based solutions to drug pricing. Tillis requested the assessment be completed and provided no later than December 31, 2022—giving the agencies 11 months.
The December 31, 2022, deadline has long since come and gone, and according to another letter sent from Tillis to the FDA and USPTO earlier this week, it appears as if the agencies are giving Tillis’ staff the run-around.
“Numerous inquiries have been made by my staff in an attempt to determine when you would complete and provide the assessment and analysis to our offices,” Tillis wrote. “Unfortunately, neither agency has provided a firm commitment regarding a transmittal date.”
If the Data is Legit, Why No Answers?
While the FDA and USPTO are not ignoring Senator Tillis or his staff, extension after extension come and go without either agency giving any commitment as to when the assessment and analysis will be completed and ultimately provided.
Why won’t the FDA and USPTO comment on the accuracy and trustworthiness of data being used by proponents of lower drug prices? It does not take a rocket scientist to identify the many false and misleading assertions that have been made, so what is taking so long and why can’t Senator Tillis get a response to his question?
Veracity and trustworthiness in data is always an important matter when engaging in decision-making of any kind, and obviously with public policy matters, reliability of data is crucial. And an assessment of the reliability of data relied upon during the drug pricing debates is of immediate importance today because the Senate Judiciary Committee will hold a hearing next week—on Tuesday, May 21 at 10:00am—discussing the affordability and accessibility of prescription medications. It is virtually certain that at least one of the witnesses who will testify at that hearing will rely on what can only be described as false data to support their preconceived conclusions that patents are the reason for high drug prices.
I-MAK’s Accuracy Problem
It is well known that I-MAK makes false assertions, which are then parroted by witnesses and the popular press alike. I-MAK has made false and misleading claims about the number of patents that cover brand name drugs. For example, I-MAK has claimed that the Novartis drug Gleevec® is covered by 73 patents, when in fact the number of patents actually covering Gleevec is 6. I-MAK admits the source of their deception in the footnotes saying they are including expired patents, pending applications and four-dozen abandoned patent applications to arrive at the number 73. Obviously, expired patents do not cover anything, and abandoned applications could never mature into an issued patent. Yet, these facts do not prevent I-MAK from making false factual assertions the underlying data simply won’t support.
I-MAK has also argued that patents are preventing generic competition in several situations where generics were already on the market, in some cases for years. For example, as late as July of 2023, I-MAK’s website proclaimed that there was no generic alternative to Pfizer’s drug Lyrica approved by the FDA or available on the market. This false claim ignores the reality that the FDA approved multiple applications for first generics of Lyrica in July 2019. And while some may chalk this up to a of reckless mistake, I-MAK has made similarly false claims about Revlimid® and Gleevec®. I-MAK claimed patents on Revlimid® would prevent generic competition until at least 2028 despite Teva launching the first generic in 2022. I-MAK claimed patents on Gleevec® would delay generic competition until at least 2029 despite Sun Pharma launching a generic in 2016.
So much of what I-MAK says is easily proven to be false. So, why is I-MAK is making outrageously false claims? Are these claims intentionally false and made to inappropriately influence lawmakers on important matters of public policy? Why do those who blame patents for high drug prices rely on I-MAK data even after it has been repeatedly shown to be false, if not altogether fraudulent? And why won’t the FDA and USPTO state the obvious—this information is wholly unreliable and should not be used to set policy or make law.
Defending False Narratives
There is no doubt that false I-MAK data grabs headlines and hijacks the entire public policy conversation. Senator Tillis should absolutely be asking why the FDA and USPTO refuse to provide his requested assessment and analysis. Could it be because they do not want to call out false data that is influencing the drug pricing conversation? Could it be because the Biden Administration wants to push patent-busting policies across the finish line and doesn’t mind relying on misdirection and subterfuge if necessary?
Sadly, there are many false narratives circling the important conversation about drug pricing in America. The notion that the U.S. government pays for the research and innovation leading to prescription drugs is another situation where what people think they know to be true is so misleading as to be practically false.
“NIH spends $8 billion a year on R&D; that is less than we spend as one company. We spend $10 billion a year,” Corey Salsberg, Vice President and Global Head of IP Affairs for Novartis said at IPWatchdog’s Life Sciences Masters™ program in October 2023. “About 1% of the spend of the private sector is what the government spends.” Salsberg also explained that what the government funds is basic research on “a new target on a cell in a body that wasn’t know—a druggable target—not research on a drug to actually drug that target.” So, it is pure folly to say, suggest, or imply that the federal government is paying for or innovating drugs.
To Actually Lower Drug Prices, First Stop Blaming Patents
The question of drug pricing raises many complicated questions, and policy must be based on a true and accurate vision of the numerous complex underlying facts. Drugs in America cost more than the public wants to pay, but it is pure folly to address this problem while ignoring the billions of dollars collectively spent on both research and development and the FDA regulatory framework that ensures only safe and efficacious drugs reach the market. R&D is not free, and neither is an FDA process that can take years, if not a decade, to navigate.
Although patents are an easy target, they are not the problem. If patents were the problem, why would I-MAK and others produce and rely upon false data? Simply put, if truth were on the side of those blaming patents for high drug prices, there would be no need to mislead, and certainly no reason to continue to rely on dubious data even after it has been shown to be false.
Image Source: Deposit Photos
Author: roxanabalint
Image ID: 69498861
