Generic Drug User Fees Reauthorization: A Victory for Public Health

Posted on October 17, 2017 by FDA Voice

By: Kathleen Uhl, M.D., and Michael Kopcha, Ph.D., R.Ph.

We marked an important milestone in the U.S. generic drug program on Oct. 1, 2017 – the start of the first reauthorization of the Generic Drug User Fee Amendments(GDUFA). These fees from industry provide FDA with vital funding that advances the Agency’s regulatory work to review and approve applications for generic drugs.

Kathleen Uhl, M.D., is Director, Office of Generic Drugs at FDA’s Center for Drug Evaluation and Research

This wasn’t just a milestone for FDA – it was a victory for public health. Increasing consumer access to safe, high-quality, and affordable generic drugs is a top priority at FDA. Generic drugs often cost a fraction of the price of the brand-name version and almost 9 out of 10 prescriptions are filled using generic drugs. During the past decade, generic medicines have saved the American health care system almost $1.7 trillion.

While FDA does not have a direct role in establishing drug pricing, when more than one generic version of a drug is approved, it spurs competition and facilitates affordable options for consumers.

Congress first approved the collection of user fees from industry to help fund FDA’s generic drug program in 2012 – for a five year period. Having another source of funding beyond our traditional budget appropriations from Congress for an extended period of time allowed us to hire additional staff and to better allocate our review activities. As a result, FDA approved record numbers of generic drug applications.

In fact, 25 percent of all generic drugs currently approved were approved during the first five years of GDUFA. In the last two years of GDUFA, the FDA approved more generic drugs each year than in any other year in the history of the generic drug program. The reauthorization of GDUFA will help us build on this success.

Michael Kopcha, Ph.D., R.Ph., is Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research

User fees support the dedicated FDA staff who review generic drug applications and inspect the facilities that make generic drugs. User fees provide funds for important IT infrastructure that helps FDA manage its increasing workload, improves efficiency, and increases transparency. They also fund important regulatory research that helps clarify and improve the scientific and clinical understanding that serves as the foundation for generic drug product assessment.

The goals and commitments we agreed to in the reauthorization of GDUFA support public health. We now have shorter review goals available for applications that are public health priorities. In addition, these goals promote two major objectives: reducing the time it takes to approve generic drug applications and increasing the number of approved generic drugs. We have increased communication with industry to help ensure that the Agency receives complete, high-quality, and scientifically sound applications. Another new feature is a flexible user fee structure to address the needs of small businesses. This encourages competition that in turn can result in lower drug prices for consumers.

Developing the generic version of complex drug products – such as inhaled medicines or some types of injectable medicines – has unique challenges. FDA will meet earlier and more frequently with an applicant to anticipate the challenges that might arise in the development of these products.

Our experience in GDUFA allowed us to improve review processes and implement best practices for communicating with industry and consumers. The reauthorization of GDUFA builds on the successes during the first five years. We look forward to the next five years of helping the American public gain even greater access to affordable, high-quality generic drugs.

Please visit fda.gov/genericdrugs for more information on FDA’s generic drug program and to track progress on the reauthorized GDUFA.

Kathleen Uhl, M.D., is Director, Office of Generic Drugs at FDA’s Center for Drug Evaluation and Research

Michael Kopcha, Ph.D., R.Ph., is Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research