Feldman and Frondorf have researched every generic drug approved by the FDA and whether or not that producer was sued for patent infringement by the pharmaceutical company that originally made the non-generic form of said drug. Sickening but enlightening review of this horrible practice to keep drugs priced higher, and prevent those who have illness from truly affording the medical help. Made me sick to my stomach. Good thing Pepto Bismol is over the counter.

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