FDA celebrates the 35th anniversary of the Hatch-Waxman Amendments

FDA celebrates the 35th anniversary of the Hatch-Waxman Amendments

Today marks the 35th anniversary of the “Drug Price Competition and Patent Term Restoration Act of 1984,” commonly referred to as the Hatch-Waxman Amendments. These amendments established the modern-day approval pathway for generic drug products, among other things. The FDA Generic Drug Program has had many accomplishments to celebrate over the last 35 years.

When the Hatch-Waxman Amendments were enacted in 1984, generic drugs accounted for only 19% of all prescription drug purchases in the United States. That number is now more than 90%. Due to FDA’s actions and the policies advanced under the Hatch-Waxman Amendments and the Generic Drug User Fee Amendments (GDUFA), the pipeline of generic drug applications is strong .

To continue building on the program’s historic success, the agency is taking a number of steps to facilitate robust generic competition for a new generation of complex drug products, which generally did not exist in 1984 when the Hatch-Waxman Amendments were enacted. FDA has made facilitating the development and approval of complex generic drug products a major focus of the FDA’s Drug Competition Action Plan, which is aimed at encouraging generic drug competition in an effort to help reduce drug prices.

As a reminder, starting tomorrow, FDA’S Office of Generic Drugs (OGD) and CDER’s Small Business & Industry Assistance is hosting a two-day 2019 Complex Generic Drug Product Development Workshop. FDA offers this workshop to help the generic drug industry overcome some of the challenges around complex generic drug development. OGD Director Dr. Sally Choe will provide the keynote address. This workshop is a great opportunity for the generic drug industry to hear from the agency’s experts in the complex science of generic drug development, which will further FDA’s efforts to ensure the American public has access to safe, effective, and more affordable treatment options.