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40th Anniversary of the Generic Drug Approval Pathway

The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established, among other things, the approval pathway for generic drug products under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amendments’ passage granted FDA the authority to approve abbreviated new drug applications to market generic versions of brand-name drugs without repeating costly clinical trials to establish safety and efficacy. 

In this CDER Conversation, Darby Kozak, PhD, deputy director for CDER’s Office of Generic Drugs, talks about the impact of the Hatch-Waxman Amendments on the generic drug industry, FDA’s work, and patients and consumers.

Why were the Hatch-Waxman Amendments so important for public health?  

The Hatch-Waxman Amendments—named after Senator Orrin Hatch of Utah and Representative Henry Waxman of California, who sponsored the legislation—were designed to increase competition in the pharmaceutical market by balancing the competing interests of brand-name pharmaceutical companies and generic drug manufacturers. It laid the foundation for the generic drug approval process, helping FDA ensure Americans have better access to safe and effective medications.

Before the Hatch-Waxman Amendments, there weren’t many generic drug products available, given the legal and regulatory challenges generic 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.

What have the Amendments accomplished over the past 40 years?

The Amendments transformed the generic drug industry and continue to improve public health by increasing access to needed medications. When the Hatch-Waxman Amendments were enacted in 1984, only 19% of all prescription drug purchases in the U.S. were generics. This grew to more than 53% by 2004, and today, generic drugs account for more than 90% of prescriptions filled in the U.S.

The Amendments created a new type of marketing application, the abbreviated new drug application, or ANDA, under section 505(j) of the FD&C Act. ANDAs streamline the application process by allowing a generic drug manufacturer to rely on the agency’s determination of the safety and effectiveness of an approved brand-name drug without having to conduct expensive and time-consuming clinical trials to establish safety and effectiveness. The Amendments also led to the development of the "Approved Drug Products with Therapeutic Equivalence Evaluations" publication, commonly known as the Orange Book, which provides public information on each approved generic drug's safety and effectiveness rating.

Additionally, the Amendments provided generic drug companies a “safe harbor” from patent infringement lawsuits during their generic drug development and testing. 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.

In your view, what has changed the most within FDA’s generic drug work since the passage of the Hatch-Waxman Amendments?

To me, the 2012 enactment and subsequent reauthorizations of the Generic Drug User Fee Amendments (GDUFA) have been the most significant advancement in the development, assessment, and approval process of generics in the last 40 years. Congress first enacted GDUFA in 2012 to further facilitate patient access to safe, effective, and high-quality generic drugs. GDUFA establishes greater predictability and timeliness of the review of generic drug applications through the user fees and commitments FDA and the generic drug industry agree to. It also created the GDUFA Science and Research Program, which aims to make generic drug development and assessment more efficient. This program funds needed research into new tools and methods to evaluate generic drug equivalence and makes this information available for FDA staff and the pharmaceutical industry through product-specific guidances and other types of guidances.

Since the passage of the Hatch-Waxman Amendments, both the complexity and volume of generic drug applications have grown. When the Amendments established the framework for generic drug review, most drugs were simpler small molecules in non-complex formulations with uncomplicated delivery devices. 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.

This has required FDA to develop innovative approaches and even more streamlined processes. We’ve been able to respond to these changing needs through the commitments and additional resources created by the GDUFA program. The efficiencies the GDUFA program creates can make it more feasible for manufacturers to develop generic drugs, including complex generics, which can facilitate competition, reduce the risk of drug shortages, and enhance patient access to treatment.

As OGD’s new deputy director, how do you hope to support the Generic Drug Program’s continued growth?

I’m amazed how new treatments are continually being developed for diseases that were previously thought to be untreatable. But the complexity of many of these generic drug products can present challenges for industry in development and for FDA in assessment of applications for these products, limiting patient access to needed treatments. Continuing to encourage a program that facilitates development of these needed complex generic products and proactively identifies resolutions to regulatory and scientific hurdles before they become roadblocks is one way I hope to support the Generic Drug Program’s continued growth.

Before I became OGD’s deputy director, I worked within OGD’s Office of Research and Standards for nearly a decade, where I learned firsthand how critical science, research, and transparent engagement with industry are to facilitating access to therapeutically equivalent medications. The research generated through the GDUFA Science and Research Program provides FDA and drug developers the most up-to-date scientific and technological insights. To date, the program has funded more than 100 research projects within FDA and with leading academic and industry researchers. This has aided the generic drug industry and supported public health by enabling the posting of product-specific guidances, as well as facilitating the development, assessment, and approval of numerous ANDAs.

Educating patients and prescribers about the safety and effectiveness of generic drugs also remains a priority for us. We’ve dedicated research efforts to better understand patients’ views on generics compared to brand-name drugs and share facts about the benefits of generic medications.

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. FDA hosts various hybrid events intended to stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.

In fact, today we kick off the Advancing Generic Drug Development: Translating Science to Approval conference, an annual workshop that FDA offers for the generic drug industry to help them navigate some of the possible hurdles around complex generic drug development. This free public workshop is an example of our responsible stewardship of the GDUFA Science and Research program, demonstrating our dedication to transparency and open communication on this important research to the generic drug industry and broader public.

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