Hatch-Waxman Amendments Turn 40

In an interview posted on FDA.gov on Sept. 23, 2024 (1), Darby Kozak, PhD, deputy director for the Center for Drug Evaluation and Research (CDER), Office of Generic Drugs, in FDA, provided a look back at the Hatch-Waxman Amendments of the Federal Food, Drug, and Cosmetic Act, also known as the Drug Price Competition and Patent Term Restoration Act of 1984. The Hatch-Waxman Amendments established an approval pathway for generic-drug products and granted FDA authority to approve abbreviated new drug applications for generic versions of branded drugs (2).

According to Kozak, the amendments were created to increase market competition between generic-drug companies and pharmaceutical companies. “Before the Hatch-Waxman Amendments, there weren’t many generic-drug products available, given the legal and regulatory challenges generic[-drug] companies faced. Unlike today’s process, generic-drug applicants couldn’t rely on the agency's determination of safety and effectiveness of the brand-name drugs they hoped to replicate. To apply for FDA approval of a generic drug, companies had to submit a full application package, which often included conducting their own clinical trials to establish safety and effectiveness of the generic drug. Repeating those clinical trials was expensive and unnecessarily time-consuming, since the brand-name drugs were already determined to be safe and effective,” said Kozak.

The amendments resulted in a growth in the generic-drug market, according to Kozak, with generic drugs increasing from 19% of the market in 1984 to 90% in 2024. The amendments also led to the Orange Book being created, which provides information on the safety and effectiveness of approved generic drugs.

“Additionally, the Amendments provided generic-drug companies a ‘safe harbor’ from patent infringement lawsuits during their generic-drug development and testing,” said Kozak. “Under Hatch-Waxman, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy. Brand-name drug manufacturers gained certain benefits as well, such as the ability to market their drug exclusively for required periods of time before a generic drug can be approved by FDA for market entry.”

Since the passage of the Hatch-Waxman amendments, Kozak points to the enactment of the Generic Drug User Fee Amendments (GDUFA) as a significant advancement in the generic-drug approval process. GDUFA provides predictable and timely review of generic drug applications, which, according to Kozak, is important because the volume of generic-drug applications has significantly grown, and the products have become more complex.

“When the amendments established the framework for generic drug review, most drugs were simpler small molecules in non-complex formulations with uncomplicated delivery devices,” said Kozak. “These products also generally used well-understood manufacturing processes and were easier to characterize and evaluate through traditional bioequivalence methods, such as systemic pharmacokinetic studies. Forty years later, many drugs have more complicated active ingredients, formulations, dosage forms, routes of delivery, and delivery devices, and therefore are harder and more costly to develop and assess. As a result, there are fewer of these ‘complex drugs’ on the market for the patients who need them.”

Kozak stated that he sees the complexity of generic-drug products as a challenge that needs the Generic Drug Program to facilitate their development and approval. “We also continue to grow the Generic Drug Program by creating and maintaining opportunities to communicate with the public and drug developers, so that we can respond to patients’ and consumers’ needs. We provide collaborative research, training, and facilitate exchange of resources among groups interested in the development of complex generic products,” he stated.

References

1. FDA. 40th Anniversary of the Generic Drug Approval Pathway. CDER Conversations. FDA.gov, Sept. 23, 2024 (accessed Sept. 25, 2024).
2. Congress.gov. "H.R.3605–98th Congress (1983-1984): Drug Price Competition and Patent Term Restoration Act of 1984." Sept. 6, 1984. https://www.congress.gov/bill/98th-congress/house-bill/3605.