Drug Wars: How Big Pharma Raises Prices and Keeps Generics off the Market

by Robin Feldman, Evan Frondorf

While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.

Genres: Health, Economics, Science, Nonfiction

160 pages, Hardcover

Published June 9, 2017

Reviews

[Kelly Mai]

pay for delay in 3 clean stages 1.wow 2.ow and 3.HOW did we get HeRe

is this more so a problem with the patent system itself or the PBM pay structure? like product hopping is p endemically problematic but i vote the latter is prob a redder flag thank u

[Austin Barselau · Rating 4 out of 5]

Drug Wars: How Big Pharma Raises Prices and Keeps Generics Off the Market is two law professors’ dissection of the “schemes, strategies, and tactics” drug patentees have employed to forestall generic prescription drug market entry. University of California Professors Robin Feldman and Evan Frondorf crisply describe how the 1984 Hatch-Waxman Act, the landmark policy that streamlined the process for generic entry, also rather unintentionally invited a series of under-the-table ploys by branded manufacturers to subvert product competition. The authors describe these anticompetitive maneuvers against generic manufacturers as occurring in three “generations”: first with “pay for delay” and reverse payment cash deals, secondly with non-cash “side deals” such as mutual licensing and development of so-called “authorized generics,” and thirdly with other strategies such as restricting testing sample access and blocking collaboration on shared risk strategies. The authors also explore the use of citizens petitions, which are formal protest vehicles that parties can use to dispute FDA decisions. Much of their analysis here is derived from their 2017 article published in the Stanford Technology Law Review, in which they argue that these petitions have often been weaponized by branded manufacturers when generic entry is close to occurring.

With this exposé, Feldman and Frondorf have pulled back the curtain on how these restrictive drug deals have impeded market competitiveness, stymied access to cost-effective medications, and ultimately increased costs for consumers.

[Ietrio · Rating 1 out of 5]

An emotional discourse based on a mediocre understanding of the news headlines.

[Rebecca Elson · Rating 5 out of 5]

This article originally appeared on The Magical Buffet's website on 06/28/2017.

When you read that I’m about to discuss a book called “Drug Wars” your mind probably goes straight to America’s “war” on illegal drugs, but you would be mistaken. There is a war involving prescription drugs going on right now that many of us had no idea existed. It’s one where pharmaceutical companies always win and the public always loses.

A long time ago, before the mid-80’s (I can’t believe I called that a long time ago!) people realized that very few generic drugs were coming onto the market. Wait, let me back up for those of you who aren’t constantly on meds like myself. So in the fashion world designer label Louis Vuitton sells its “Saint Michel” purse for $1,700. It’s a bag, it holds stuff. You can also find on your better handbag websites what are subtly referred to as “knock off” versions for a couple hundred dollars. It’s also a bag. It also holds stuff. That’s essentially prescription drugs and their generic versions, except in this case the FDA makes sure that the bags are made of the same primary material. A prescription drug can be hundreds of dollars, but a generic drug is nearly identical at a fraction of the price. With the state of health insurance then, and now, there is an interest in generics for public consumption.

Thus in 1984 The Drug Price Competition and Patent Term Restoration Act, often called the Hatch-Waxman Act, went into effect to stimulate a generic drug market. The Hatch-Waxman Act is a great idea. It attempts to strike a balance between capitalism and the common good. When a pharmaceutical company goes to market with a new chemical that company is given 5 years of exclusivity. It also streamlined the process for companies looking to bring a generic version to the market. Thus the originator gets 5 years of market dominance to recoup research costs, etc. while providing the eventual competition of a generic to make things easier on the consumer’s pocketbook and encourage pharmaceutical companies to get back to the drawing board to innovate and bring another new drug to market that again gets 5 years of competition free existence. Pretty elegant, right?

What no one saw coming, but let’s face it, those in the know probably did, was that pharmaceutical companies found ways to extend their periods of exclusivity, which of course makes things harder on us sickos of America. The use of lawsuits to stall generics going to market is common, and not surprising once you’re reading “Drug Wars”. What was shocking was the collusion between the manufacturers of the original drug and the companies making the generics. When these companies are in litigation they can fight it out, or settle. Oddly the settlement involves the manufacturer of the original drug paying obscene sums of money to the generic, and the generic agreeing to hold off going to market for several more years. There many ways safe and effect generic drugs are delayed from becoming available, and “Drug Wars” does an amazing job highlighting them. The authors, Robin Feldman and Even Frondorf, also make recommendations on how to fix these issues.

If you’re into intricate bureaucracies, healthcare in America, and a few laugh out loud absurdities then you need to read “Drug Wars: How Big Pharma Raises Prices and Keeps Generics Off the Market” by Robin Feldman and Even Frondorf.