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April 17, 2022


Thank you for writing this; very well said. Even though labeled as opinion, the New York Times piece was so inaccurate and misleading that it should not have been published.

The hard fact that the NYT ed board neglects to consider is that the patent laws of the U.S. are scarcely different than those of Canada, Europe, Japan, etc, and yet all of those countries have lower drug costs than we have. Should that not suggest that *patents* are not really the decisive factor driving our high drug costs here? The Sunday editorial rather missed the forest for the trees.

In a day and age of growing concern with DIS and MIS information, the New York Times simply




"The Times might have had a point if drug companies had taken off the market traditional insulin in vials and administered by patient injection with syringes---but a simple search shows that this is not the case."

Whole vistas of perfectly serviceable insulin varieties have been taken off the market, precisely in order to achieve the sort of evergreening that you are denying here. The URL below constitutes a complete list of commercially available insulin varieties in the U.S. Notice how there is not a single entry in there for ordinary old porcine insulin, of the sort that used to be standard of care. Indeed, not a single sort of insulin that was in use in the 1970s is still available on the U.S. market. That is because the innovator manufacturers withdraw their NDAs when the patents expire.

This is not, of course, a problem of patent law. It is a problem of FDA law. If the FDA were permitted to approve generics/biosimilars based on a *prior* NDA (instead of a *current* NDA), then we could have real generic competition in the U.S. to drive down insulin prices. There are, in other words, necessary reforms to be made---in FDA law. Fiddling around with patent law to solve this problem, however, is rather like the proverbial drunk looking for his keys under the streetlamp because that is where the light is better.


Greg: I think the reason for taking these insulins off the market is that non-human insulin has serious drawbacks longterm. When diabetics died young this wasn't an issue. But once diabetes began living longer, and human insulin came on the market, there was a change in the standard of care to avoid the immunogenicity and other issues that were accepted for porcine and other animal insulins when there was no alternative.

Also, in the 1970's "long-acting" insulins were developed by complexing them with zinc, but for the past 20 years genetically engineered versions have longer in vivo half-lives that work better. These insulins (which are provided using injectors) can also be purchased in vials and administered with syringes. That is what I was referring to; sorry if I was unclear.

Thanks for the comment.

"I think the reason for taking these insulins off the market is that non-human insulin has serious drawbacks longterm."

So does not taking your insulin for days at a time because you cannot afford it, or taking only a quarter of the necessary dose because of budget constraints. This is a bootlegger-&-baptist story. There is a noble reason for withdrawing prior art insulins from the market, and a self-interested reason. The different explanations are not mutually exclusive, and do not cancel each other out.

Mind you, I am not trying to demonize drug companies. I do not see that there is much to be gained from making policy decisions based on the halos or horns that we choose to draw behind the heads of the relevant actors.

Rather, we should simply focus on the lived reality of how FDA policy decisions affect patients. Would diabetic patients be better off with greater market competition in this space? To my mind, the answer to that question seems like a no-brainer. Even if 1970s era technology is worse than 2020 era tech, it is a darn site better than just doing without insulin altogether. We should set FDA law accordingly to achieve the better policy outcome.

Is the FDA actively BLOCKING anyone from doing the necessary steps to put in place those older technologies?

Would they for safety reasons?

As far as I can tell, the withdrawal by a first provider does not mean that a second provider is necessarily foreclosed. "IF" per Mr. DeLassus (I may not be reading his position correctly) the capability for another IS THERE "but for" the FDA itself, and that capability is ethically medically permissible, then that option should ALREADY be available, correct? If that option is NOT ethically medically permissible, then Mr. DeLassus may be asking for something that should NOT be granted.

You were expecting truth from the NYT? This is the same outfit that told us that Trump was collaborating with Russia, that buried the Hunter Biden laptop story, and whose editorial staff in the summer of 2020 threw a collective tantrum because their boss said some things they didn't like. And that's before considering the NYT's long and inglorious track record of attacking patents and innovation, which you've discussed on many occasions, as mentioned in your last paragraph. (I also wrote about this last year, here: https://www.iliplaw.com/americaisrael_patent_law/2021/09/new-york-times-gets-it-wrong-but-whats-new.html).

I'm surprised anyone still subscribes to NYT, let alone uses it for anything other than wrapping dishes before moving house, or cleaning a certain bodily orifice.

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