Oct 2024: The real legacy of the Hatch-Waxman Act

14 Oct 2024

It is long past time for Congress to reform the Hatch-Waxman Act

Last month, the Hatch-Waxman Act turned forty years old. Depending on where you looked, this milestone was treated very differently.

In pharmaceutical industry circles, the Act was celebrated as a law that “laid the foundation for biopharmaceutical competition” and “has helped to significantly increase access and lower costs to the medications.”

Meanwhile, we at I-MAK joined academics and drug pricing experts to examine the Act’s true legacy and what it actually gave us: the highest drug prices in the world.

Forty years ago, as lawmakers were crafting the Hatch-Waxman Act, the pharmaceutical industry and its lobbyists were doing everything they could to kill the bill. When they recognized they couldn’t, they began lobbying Congress to weaken it. In the end, the industry successfully fostered several loopholes in the bill that they’ve exploited over the last forty years to extend their patent monopolies. 

Due to its many flaws and despite its intentions, the Hatch-Waxman Act has become a tool that branded drug companies routinely exploit and abuse to extend blockbuster monopolies and drive up drug prices. It is long past time for Congress to reform it.

To understand the real legacy of the Hatch-Waxman Act and why Congress needs to overhaul it, we invite you to watch and share our new video that lays out the history of how the Hatch-Waxman Act came to be and the concessions that were made.

Additionally, you can read my latest Op-Ed in STAT, co-authored with Timi Iwayemi of the Revolving Door Project, in which we break down how Hatch-Waxman has driven up drug prices and the necessary steps for course correction.

We cannot undo the harm that has been caused by the first forty years of the Hatch-Waxman Act, but we can chart a better course forward.

Onwards,
Tahir

What We’re Reading

FTC Chair Lina Khan went on 60 Minutes and explained to millions of Americans how pharmaceutical companies are abusing the patent system to keep drug prices high. In one forty-second snippet, she uses an inhaler to efficiently demonstrate what a junk patent is and just how hollow some so-called “innovations” really are.

For context on the important work Chair Khan’s FTC has been doing to clear junk patents out of the FDA’s Orange Book, watch another video we recently released, which breaks down what Orange Book abuse is, why so many branded drug companies do it, and why Congress and the FDA need to do more to stop it.

As election season comes down to the final stretch, I wrote in Law360 about how, in order to fulfill voters’ desire for lower drug prices, Vice President Harris will need to take on the pharmaceutical industry’s patent abuse.

Something Hopeful

Wayne Brough is an economist and resident senior fellow at the R-Street Institute, a think tank that prioritizes free market and limited, effective government solutions. We asked Wayne how branded drug companies’ patent abuse impacts drug prices.

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