Robin Feldman

A Klaxon Call. In this exceedingly well documented scholarship, Feldman presents the case well. And what an alarming case it is. Drug manufacturers have found ways to game the system at all levels such that the existing system in the US actually *encourages* ever higher drug prices - even as patients are crying out under the strain and in many cases forgoing life saving medication due to not being able to afford it. Feldman explains the problem at all levels though four of the six chapters of the book, with the first chapter being an overall introduction to the problem and the final chapter being suggested solutions - including a range going from possibly politically palatable yet likely ineffective to very likely effective but less likely to be politically palatable. Overall a stunning work that could - and likely should - drive at least some discussions through the 2020 election cycle.… (mere)

A measure of just how perverse US pharmaceutical markets have become is the “reverse payment” in which the original manufacturer sues the maker of the new generic version for patent infringement, then settles by paying the generic maker to go away for several months before launching its version. If that is intriguing instead of revolting, Drug Wars is for you.

Feldman and Frondorf have researched all the Food and Drug Administration’s generics files going back to the turn of the century, and found a treasure trove of manipulation, waste and greed that prove why we need an FDA in the first place. That the FDA is being crippled by all these shenanigans is criminal.
To the tune of billions of dollars a year.

The name of the game is delay. Every month of delay can mean tens of millions of dollars from consumers and insurers overpaying. A year’s delay can easily mean a billion dollars’ profit. The frightening total is that 45% of Pharma revenues worldwide come from American patients. Because no other country lets them get away with this.

Some of the tactics Big Pharma uses:
-claiming its drug is so dangerous it can only be handled in and by a single named drugstore, making it unavailable generally, and specifically not to a generics firm wishing to examine it
-delaying selling a sample to a generics firm for years, until they go away
-changing one tiny aspect of the drug so the generic no longer copies it (could be the packaging or the directions). Business process patents have nothing to do with drug efficacy, but count in patent law
-filing a citizen petition questioning the methodology to measure the generic’s performance. The FDA routinely rejects them (some years 100% of them), but Big Pharma keeps filing to keep delaying
-when a drug firm removes a drug completely, the remaining generic is disqualified from most formularies because there is no alternative to it. It (ironically) defaults to brand status itself, and goes unfilled. Pharma then releases a new version, free of generic competition.

Big Pharma fills the courts with frivolous suits, loads down the FDA with nonsenses complaints (demanding tests that are already required, for example) and applications, and stalls. A finding that a drug might be dangerous may not be filed for years – until a generic appears on the scene. Bogus applications that slow down generic approvals are routinely rejected – but they serve the purpose by taking up valuable time, at taxpayer and patient expense. While Drug Wars has a worthy conclusion packed with sensible recommendations, it is clear Congress will not act on them, and that lifesaving drugs should not be left to the “free” market.

David Wineberg… (mere)