Survivors for Solutions Celebrates the 40th Anniversary of the Hatch-Waxman Act
By John “CZ” Czwartacki, Founder & Chairman
As a patient who has been lucky to have access to a variety of breakthrough treatments throughout the 30 years I’ve lived with multiple sclerosis (MS), I understand the value of medical innovation through my own experiences. In founding Survivors for Solutions, I wanted to not only advocate for efforts to protect patients in our biomedical innovation ecosystem but also celebrate existing laws and policies that have furthered this goal.
September 24 marks the 40th anniversary of one such law—the bipartisan Drug Price Competition and Patent Term Restoration Act, better known as Hatch-Waxman. This vital legislation changed the drug innovation landscape as we know it, and patients have been extremely lucky over the last four decades to reap the benefits of an improved medical innovation ecosystem supported by intellectual property rights needed to incentivize these developments. Survivors for Solutions is happy to wish Hatch-Waxman a Happy 40th Birthday as we celebrate the breakthrough treatments patients have received thanks to the law.
The Hatch-Waxman Act established vital procedures that have delivered treatments and cures to patients in need. By creating an expedited road to Food and Drug Administration (FDA) approval, a shield for generic applicants against patent infringement charges until they request FDA approval, and by extending patent terms to compensate for time spent in the approval process, the law eased the process of bringing drugs to market. Thus incentivizing investment, research, and development into new medications. The “regulatory exclusivity” granted in Hatch-Waxman, which provides a limited protection period during which an approved drug is protected from competing applications, has been particularly critical in allowing innovators to conduct the research that delivers new products to market.
The continued development of generics is paramount to patient access and health. Recent data shows that 90 percent of all prescriptions in the United States are filled with generic drugs. These types of medications are critical because they typically cost significantly less than their brand-name counterparts, meaning that patients suffering from a wide variety of conditions—including rare, chronic, and life-threatening diseases, can access treatments that were previously rare and extremely costly. In short, Hatch-Waxman revolutionized the generics process by creating a higher volume of affordable medications and making treatments available to patients across the board.
While most Americans may have never heard of it, the Hatch-Waxman Act led to the development of many drugs patients rely on today. By protecting intellectual property rights while easing the approval process to incentivize drug development, this law has been integral to the creation of the flourishing innovation ecosystem we have in the United States. Not to mention, this law was introduced by a Republican and Democrat and passed with support from both sides of the aisle—unlike the IRA, which was passed along party lines with supporters knowing this would upend nearly 40 years of bipartisan consensus and pro-innovation policy.
Moving forward, Congress must prioritize maintaining key patent protections and innovation-incentivizing provisions, as well as pushing back on policy agendas – like drug price controls—that will damage drug research and development and hurt the patients relying on the creation of new treatments. With divisive rhetoric and policy agendas in this contentious election year, the Hatch-Waxman Act’s anniversary serves as a key reminder of the solid foundation in which our development pipeline is rooted and how far we have come.