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AAM White Paper: Hatch-Waxman turns 40

The organization noted that the 1984 law has enabled trillions of dollars in savings, but the industry is at risk.
Sandra Levy
Senior Editor

The Association for Accessible Medicines released a report touting the lasting benefits the generic drug industry has provided to patients, employers and taxpayers in the 40 years since the enactment of Hatch-Waxman, the landmark Drug Price Competition and Patent Restoration Act of 1984, but also the unprecedented challenges facing the industry calling into question the viability of sustainable competition from low-cost medicines.

AAM noted that 2024 marks the 40th anniversary of Hatch-Waxman, which created a pathway for the introduction of lower-cost generic drugs. 

The results have yielded savings successes over the last several decades: according to AAM’s most recent annual savings report, in the last 10 years alone, the use of generic drugs saved patients and the U.S. healthcare system almost $3 trillion dollars. But this track record of success—and the resulting increase in patient access to care—is currently at risk, the organization said.

[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]

“Since the introduction of this law, we have all seen incredible savings,” said David Gaugh, AAM’s interim president and CEO. “But even as we celebrate the success of 40 years of Hatch-Waxman, those savings, the increased patient access, and a model of generic adoption that leads the world, are at risk. It is incumbent upon us as leaders of this industry to come together with policymakers and other key stakeholders to safeguard and stabilize not only future savings, but future care to America’s patients.”

The new report, “Hatch-Waxman at 40: Is it over the hill (or is The Hill over Hatch-Waxman?),” details the unprecedented challenges facing the generic and biosimilar industries today, including unchecked price deflation, fewer new generics and slower market penetration for new generics, slower than expected biosimilar adoption and drug shortages. The report seeks to educate policymakers on the threats to future generic and biosimilar savings, the root causes generating these threats. It suggests legislative and regulatory action that can be taken by policymakers in Congress, the White House and state governments to preserve and enhance generic and biosimilar competition and sustainability.

The report was released as generic and biosimilar industry leaders, key stakeholders and policymakers gathered in Tampa for AAM’s annual conference, ACCESS!2024, to consider the business, breakthroughs and politics that shape the industry—and in particular, the economic risk to its long-term sustainability.

[Read more: Sufficiently similar: What the FDA approval of the first interchangeable biosimilar product means for pharmacists]

The report can be found here.

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