2016: A Record-setting Year for Generic Drugs

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.

Kathleen "Cook" UhlAnd 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 CoverWith 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

FDA Drug Trials Snapshots and Diversity When Testing New Drugs

By: John J. Whyte, M.D., M.P.H.

Did you know that some drugs affect men and women differently? For instance, women are often prescribed only half the dose that men take of the sleep medication, Ambien (zolpidem). Race and ethnicity also make a difference. One type of drug commonly used to treat high blood pressure, angiotensin-converting enzyme (ACE) inhibitors, has been shown to be less effective in African American patients than in white patients.

John WhyteThese are just two examples of why it’s important to test drugs on the appropriate patient populations. This is especially true for drugs we call “novel drugs,” new medicines that have never been used before in the U.S. marketplace. Over the past two years, FDA’s Center for Drug Evaluation and Research (CDER) approved 67 novel drugs. So it’s no surprise that in recent years, representation in clinical trials of certain subgroups, such as people of different ages, races, ethnic groups, and genders, has become of growing interest.

To help keep the public better informed, CDER piloted the Drug Trials Snapshots program two years ago to provide easily accessible information about patient representation in clinical trials. Snapshots show who participated in the studies used to approve a novel drug and organize information from the studies by sex, race, and age subgroups. Further, they provide a brief narrative on whether there were any reported differences in how the drug worked by subgroup and whether there were any reported differences in side effects among the different groups. Since January 2015, CDER has published a Drug Trials Snapshot within a month of each novel drug’s official approval date.

Just this week, we released our Drug Trials Snapshots Summary Report, which provides a yearly average of the diversity of participants in the clinical trials for novel drugs approved in 2015 and 2016. It shows for example, that women were represented at a rate of 40 percent in 2015 and 48 percent in 2016 and African Americans were represented at a rate of 5 percent in 2015 and 7 percent in 2016. The report also lays out the extent to which safety and effectiveness data are based on demographic factors such as sex, age, and race. At its heart, this report is an effort to be transparent – to provide information to the public, and actually show the number and participation of men and women, of various races and age groups within the clinical trials. Being able to share more information and facts will help us to facilitate a thorough and robust discussion about clinical trial demographics. Now, anyone can go to the site and see the numbers for themselves in a quick snapshot.

Until the late 1980s, clinical trials were conducted predominantly on men. Much has changed since then. Our Drug Trials Snapshots program and Summary Report underscore FDA’s commitment to enhancing transparency and better understanding of patient representation in clinical trials.

John J. Whyte, M.D., M.P.H., is Director of Professional Affairs and Stakeholder Engagement at FDA’s Center for Drug Evaluation and Research