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by refurb 2243 days ago
The generic drug industry in the US is pretty unique. Thanks to the Waxman-Hatch generic drug bill in 1984, it went from really hard to get a generic drug approved in the US (you had to start from scratch) to really easy (just prove your drug is the same and use the branded drugs data for approval).

As a result, the generic drug industry in the US is very competitive. When a blockbuster drug like Liptior goes generic, you have up to a dozen companies vying to be the first generic approved because that gets you 180 days of exclusivity (you're the only generic, you're cheaper, everyone switches to you). Typically the first generic is priced around 90% of the brand name price (most of it profit), but once other generic companies get approval (after 180 days), the price drop to 5-10% of the branded drug price. This is typically very close to the cost of manufacturing. There are also "generic substitution" laws in most states that require pharmacists to fill prescriptions with the generic. So once the patent runs out, the branded drug loses sales very fast.

As a result, the US usually has lower generic drug prices than the EU or Canada.[1] And generic drugs tend to get approval very quickly after the patent expires in the US.

However, on the flip side, because the market is so competitive, margins are razor thin. If you want to understand the generic drug market, read the book "The First Question" by Andrew Bodnar. He was convicted by the DOJ for anti-competitive practices as a VP at BMS and wrote the book as a part of his sentencing (book is on the public record). The quote that stuck with me was from Barry Sherman of Apotex (massive Canadian generic drug company). It was something along the lines of "I make zero profit off my drugs. All my profit comes from winning settlements from pharma companies".

As a result of the razor thin margins, weird things start to happen. The first is price fixing, as per this article. Nobody wants to compete on price in generic markets (though that's the only differentiator between identical drugs!) because their margins already suck. Allegedly, these companies colluded to not drop prices.

The other thing that happens is companies just say "screw it" and drop out of the market. Why not? The profit margin is near zero. This is especially true with companies selling sterile fill product (i.e. injectables). It's really freakin hard and expensive to run a sterile fill plant, so when something goes wrong, companies often just shut down the line.

What happens? Drug shortages. Prices rises.

Then what happens? Some small company realizes everyone else dropped out of the market. So they quietly get their generic approved and jack the price as high as they can. You'll see a drug that was $0.10 per tablet go to $10 per tablet. Then this attracts other competitors (or sometimes it doesn't), prices drop and the cycle starts again.

[1] Can't find exact study, but here's an FDA study comparing generic drug prices between US and Canada: https://www.fda.gov/drugs/resources-you-drugs/study-us-gener...

6 comments

> If you want to understand the generic drug market, read the book "The First Question" by Andrew Bodnar. He was convicted by the DOJ for anti-competitive practices as a VP at BMS and wrote the book as a part of his sentencing (book is on the public record).

Was he literally sentenced to write a book (among other things, I'd have to assume)? If so, I have so many questions. Was this part of a plea deal, or did a judge decide it on their own? Is this a common thing? Has this judge done that before? If someone is sentenced to write a book, how is the timeline set for it? What happens to the profits from sales? Who pays for the editing/publishing/etc.?

The judge made it a part of the sentencing, plus 2 year probation. The judge was hoping his story could serve as a warning to other potential white-collar criminals (Bodnar claims he's innocent in the book, so not quite the warning the judge was hoping for).

The book was in the court records, but seems to have been pulled as I think Bodnar is trying to sell it now.

"When former pharmaceutical executive Andrew G. Bodnar pleaded guilty to white-collar crime in 2009, the judge didn't throw the book at him—he ordered him to write one.

Reflect upon "the criminal behavior in this case so that others similarly situated may be guided in avoiding such behavior," said the judgment from U.S. District Judge Ricardo M. Urbina in Washington. And make it 75,000 words.

The finished book, written during Dr. Bodnar's two-year probation, has been submitted into the court record."[1]

[1]https://www.wsj.com/articles/SB10001424052702303877604577382...

> As a result, the US usually has lower generic drug prices than the EU or Canada

Doing a quick over the internet comparison, comparing with actual visits to different countries: the "simpler" generics seem to be cheaper in the US (as in, getting hundreds of ibuprofen or acetaminophen capsules for a couple of dollars) where things like allergy medication or more specialized drugs are more expensive.

So the "average" might be cheaper (weighted by what?) but the distribution is certainly more long-tailed in the US

Did you look at the study I referenced?

Compared to Canada, 6 of the 7 most prescribed generic drugs are cheaper in the US.

Well the generic market only works when pay for delay and other morally bankrupt acts don't happen: https://www.ftc.gov/news-events/media-resources/mergers-comp...

and it basically doesn't work with biologics since biosimilars are far more difficult to make.

I never understood why pay for delay deals are bad.

It’s basically splitting the difference between two possible scenarios:

Scenario 1: patent is valid, generic drug doesn’t launch for 2 years

Scenario 2: patent is invalid and generic drug can launch immediately

The only reason you see pay for delay deals is when neither scenario is certain. Otherwise, why do a deal?

So they could only be called a “delay” if the patent is invalid. But if the patent was 100% invalid, the generic company wouldn’t negotiate a deal.

Most of the time, pay for “delay” deals get the generic drug on market sooner.

Do you have a link to "The First Question" by Andrew Bodnar? Can't find a source online.
Looks like I wasn't fast enough -- email is in profile if you are so inclined!
Emailed it!
> All my profit comes from winning settlements from pharma companies".

I followed the Canadian generics market in the press in the 80s and 90s. It was awesome, like the Wild West days - "what are they up to this week?"

Sherman and Shulman (Quincy TV show basd on him?) were like mini-Trumps.

That plus the Toronto calculus textbook author who needed a commercial architect ("no straight lines, please") to build his $24 million mansion, Integral House, with its own world-class concert hall. It was Sarek's house in Star Trek: Discovery.

Canadians might be polite, but have just as much business drama.

https://en.wikipedia.org/wiki/Apotex

https://en.wikipedia.org/wiki/Morton_Shulman

https://en.wikipedia.org/wiki/Integral_House

Not to mention the unsolved murder of Barry Sherman and his wife!
Yeah, I read a brief news report on that.

Kind of baffled. I'm familiar with Toronto, and I don't have any likely explanations for that kind of thing there unless it was a suicide pact without a note (they were in their mid-70s), or a badly failed kidnapping attempt.

Sherman was the #12 richest Canadian, so pretty high on the totem pole. I used to see the former #1 billionaire owner of Hudson's Bay (founded 1670!), Ken Thomson, around the main store. He displayed part of his Group of Seven collection publicly on one floor (that group was funded by the Massey-Harris fortune.)

https://en.wikipedia.org/wiki/Kenneth_Thomson,_2nd_Baron_Tho...

https://en.wikipedia.org/wiki/Group_of_Seven_(artists)

You forget where the generic drug manufacturer (intentionally) sells tainted/ineffective drugs.

https://bergermontague.com/whistleblower-lawsuit-against-ran...