2016: A Record-setting Year for Generic Drugs

Posted on February 24, 2017 by FDA Voice

By: Kathleen “Cook” Uhl, M.D.

Over the last 10 years, generic drugs have saved the U.S. healthcare system about $1.68 trillion. I’m pleased to report that 2016 was a record-setting year for FDA’s generic drug program, a result that will help generate further cost savings for American consumers, while assuring the quality of these generic products.

And the timing couldn’t be better amid concerns about rising drug prices.

Last year, FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research generated the highest number of approvals in the history of FDA’s generic drug program – more than 800 generic drug approvals, including both full approvals and tentative approvals. (Tentative approvals are granted to applications ready for approval from a scientific perspective, but cannot be fully approved due to patents or exclusivities on the brand-name drug.) Last year’s performance surpassed 2015’s previous record of 726. Many of these approvals were for “first-time generic drugs,” meaning the introduction of a generic counterpart for a brand-name product for which there was previously no generic. That’s typically the first step towards lower drug prices because multiple generic versions of brand-name drugs drive price competition, leading to more affordable drugs.

An important factor in OGD’s record-setting performance has been the Generic Drug User Fee Amendments (GDUFA) of 2012, a landmark legislation negotiated with the generic drug industry, which completely reshaped the generic drug program at FDA. Among other things, it authorized funds for FDA to hire additional reviewers, modernize the review of generic drug applications, expand facility inspection capabilities, advance IT infrastructure for generic application review, and perform other regulatory actions. This is the first time Congress has authorized a user fee program specifically for generic drugs. It’s a five-year program, up for renewal October 1, 2017. GDUFA I has challenged OGD to reach a variety of goals while maintaining or improving the quality of the review process.

2016 Office of Generic Drugs Annual Report Cover

With the assistance of many other offices throughout FDA, OGD is on track to meet, or has already met, all of our GDUFA commitments. In addition to increased approvals and tentative approvals, FDA improved communications processes to alert industry to deficiencies in their applications, which reduces the number of review cycles and supports faster approvals.

We also are making a significant effort to spur generic drug development. For example, GDUFA Regulatory Science priorities contribute valuable research to generic drug development. Our efforts are geared to helping the generic drug industry develop validated scientific methods for demonstrating bioequivalence and assuring therapeutic equivalence to the brand-name counterpart. We are translating the results of these scientific efforts into generic drug product development via recommendations for specific drug products, which assist the generic drug industry during product development.

These are just a few of the exciting developments for 2016. Our annual report tells the rest of the story.

Despite these developments in 2016, a lot remains to be done as we approach the end of our first-ever five-year GDUFA program. We look forward to working with industry, the research community, physicians, lawmakers, and other stakeholders to help American consumers and advance use of generic drugs in our nation’s health care system.

Kathleen “Cook” Uhl, M.D., is FDA’s Director, Office of Generic Drugs in the Center for Drug Evaluation and Research