Pluralistic: The FTC has Big Pharma's number (23 Nov 2023)

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A scientist laboring in an apparatus-filled chemistry laboratory. His head has been replaced with a fedora-topped businessman's head, a faint sneer on his face. The flask he is peering into contains a floating orange book.

The FTC has Big Pharma's number (permalink)

The most consistent bright spot in the dark swirl of US politics is the competence of the Biden Administration's progressive enforcers: people like Rohit Chopra, Jonathan Kanter and Lina Khan, who keep demonstrating just how far a good administrator can go. Anyone can have a vision, but knowing how to execute is the difference between hot air and real change:

Take a minute to contrast Biden's administrators with Trump's: Trump's administrators had an ideological vision just as surely as Biden's do, and Trump himself had a much more pronounced and explicit ideology than Biden, whose governance style is much more about balancing the Democratic Party's blocs than bringing about a specific set of policies:

But whatever clarity of vision the Trump administration brought to DC was completely undermined by its incompetence (thankfully!). Apart from one gigantic tax break, Trump couldn't get stuff done. He couldn't deliver, because he'd lose his temper or speak out of turn:

And his administrators followed his lead. Scott Pruitt was appointed to run the EPA after a career spent suing the agency. It could have been the realization of his life's dream to dismantle environmental law in America and open the floodgates for unlimited, wildly profitable corporate pollution and pillaging. But the dream died because he kept getting embroiled in absurd scandals – like the time he sent his staffers out to drive around all night looking for a good deal on a used mattress:

Or his insistence on installing a CIA-style "Sensitive Compartmented Information Facility" (SCIF) so he could play super-spy while reading memos:

Or the time he sent his security detail to the Ritz-Carlton to demand that they supply him lots of little bottles of his favorite hand-cream:

There were other examples in the Trump administration, but Priutt is such a good case-study. He's like a guy who spent his whole life training to compete in the Olympics, and finally got a shot, only to be disqualified for ordering too much room-service in the Olympic Village. Priutt was wildly ambitious, but he was profoundly undisciplined – and wildly incompetent.

Compare that with Biden's progressive enforcers and agency heads, who showed up on the first day of work with an encyclopedic knowledge of their administrative powers, and detailed plans for using them to transform the lives of the American people for the better:

The Biden administration's competence translates into action, getting stuff done. Maybe that shouldn't surprise us, given the difference between the stories that reactionaries and progressives tell about where change comes from.

In reactionary science fiction, we enter the realm of the "Competent Man" story. Think of a Heinlein hero, who is "able to change a diaper, plan an invasion, butcher a hog, conn a ship, design a building, write a sonnet, balance accounts, build a wall, set a bone, comfort the dying, take orders, give orders, cooperate, act alone, solve equations, analyse a new problem, pitch manure, program a computer, cook a tasty meal, fight efficiently, die gallantly."

In Competent Man stories, a unitary hero steps into the breach and solves the problem – if not single-handedly, then as the leader of others, whose lesser competence is a base metal that the Competent Man hammers into a tempered blade:

Contrast this with a progressive tale, like, say, Kim Stanley Robinson's Ministry For the Future, where the Competent Man is replaced by the Competent Administration, in which people of goodwill and technical competence figure out how to join forces to create population-scale architectures of participation that allow every person to contribute their skills and perspective:

The right's whole ideology insists that the world can only be saved by Competent Men. As Corey Robin writes in The Reactionary Mind, the unifying factor that binds together conservative factions from monarchists to racists to Christian Dominionists is the belief that a few of us are born to rule, and the rest to be ruled over:

The Reaganite insistence that governments are, by their very nature, incompetent and malign ("The nine most terrifying words in the English language are, 'I’m from the government, and I’m here to help'"), means that conservatives deny the possibility of a Competent Administration.

When conservatives take office and proceed to bungle the most basic elements of administration, they're fulfilling their own campaign narrative, which starts with "We must dismantle the government because it is bad at everything." Conservatives who govern badly prove their own point, which explains a lot about the UK Tory Party's long run of governmental failure and electoral success:

There's a small mercy in the fact that so many of the most ideologically odious and extreme conservative governments are so technically incompetent in governing, and thus accomplish so little of their agendas.

But the inverse – the incredible competence of the best progressive administrators – is nothing short of a delight to witness. Here's the latest example to cross my path: the FTC has intervened in a lawsuit over generic insulin pricing, on an issue that is incredibly technically specific and also fantastically important:

The underlying case is before the FDA, and it concerns the dirty tricks that pharma giant Sanofi used to keep Mylan from making a generic version of Mylan's Lantus insulin after its patent expired.

There's an explicit bargain in patents: inventors can enlist the government to punish their rivals for copying their ideas, but in exchange, the government demands that the inventor has to describe how the invention works in a detailed patent filing, and when the patent expires, 20 years later, rivals can use the patent application as instructions for freely copying and selling the invention. In other words: you get 20 years of exclusive rights in return for facilitating your competitors' copying and selling your invention when the 20 years are up.

Pharma doesn't like this, naturally: not content with 20 years of exclusivity, they want the government to step in and punish their competitors forever. In service to that end, pharma companies have perfected a process called evergreening, where they dribble out ancillary patents after their initial filing, covering minor reformulations, delivery systems, or new uses.

Evergreening got a moment in the public eye earlier this year, with John Green's viral campaign to shame Johnson & Johnson out of using evergreening to restrict poor countries' access to TB medication:

The story of pharma is that it commands gigantic profits, but it invests those profits into medicines that save our lives. The reality is that most of the key underlying pharma research is publicly funded (by Competent Administrators who apportion funding to promising scientific inquiry). Pharma companies' most inventive genius is devoted to inventing new evergreening tactics:

That's where the FTC comes in, in this Sanofi-Mylan case. To facilitate the production of generic, off-patent drugs, the FDA maintains a database called the "Orange Book," where pharma companies are asked to enumerate all the ancillary patents associated with a product whose patent is expiring. That way, generics manufacturers who make their own version of these public domain drugs and therapeutics don't accidentally stumble over one of those later patents – say, by replicating a delivery system or special coating that is still in patent.

This is where the endless, satanic inventiveness of the pharma sector comes in. You see, US law provides for triple damages for "willful patent infringement." If you are a generics manufacturer eyeing up a drug whose patent is about to expire and you are notified that some other patents might be implicated in your plans, you must ensure that you don't accidentally infringe one of those patents, or face business-destroying statutory damages.

So pharma companies stuff the Orange Book full of irrelevant patent claims they say may be implicated in a generic manufacture program. Each of these claims has to be carefully evaluated, both by a scientific team and a legal team, because patents are deliberately obfuscated in the hopes of tricking an inattentive patent examiner into granting patents for unpatentable "inventions":

What's more, when a pharma giant notifies the FDA that it has ancillary patents that are relevant to the Orange Book, this triggers a 30-month delay before a generic can be marketed – adding 2.5 years to the 20 year patent term. That delay is sometimes enough to cause a manufacturer to abandon plans to market a generic drug – so the delay isn't 2.5 years, it's infinite.

This is a highly technical, highly consequential form of evergreening. It's obscure as hell, and requires a deep understanding of patent obfuscation, ancillary patent filings, generic pharma industry practice, and the FDA's administrative procedures.

Sanofi's Orange Book entry for Lantus insulin listed 50 related patent claims. Of these, 48 were invalidated through "inter partes" review (basically the Patent Office decided they shouldn't have allowed these claims to be included on a patent). Neither of the remaining two claims were found to be relevant to the manufacture of generic Lantus.

This is where the FTC's filing comes in: their amicus brief doesn't take a position whether Sanofi's Orange Book entries were fraudulent, but they do ask the FDA to intervene to prevent Orange Book stuffing because "improper listings can cause significant harm to competition and consumers."

This is the kind of boring, technical, important stuff that excellent administrators can do. The FTC's brief is notice to the FDA that it should amend its procedures to ban (and punish) Orange Book abuse. That will make it possible for you, a person who needs medicine, to get that medicine more cheaply and quickly. In America's pay-for-use privatized healthcare hellscape, this could be a life-or-death matter.

There's plenty of things the Biden administration is getting very, very badly wrong, but we shouldn't lose sight of how its progressive wing is making real, lasting change for the better. Competent Administrations are the true peoples' champions. They beat Competent Men every time.

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