Building a Modern Generic Drug Review Process

By: Stephen Ostroff, M.D.

Recent hearings on Capitol Hill highlighted an issue of growing importance for patients and for public health: access to quality, affordable medicines, in particular generic drugs. FDA’s generic drug program promotes access to quality affordable medicines by reviewing Abbreviated New Drug Applications (ANDAs), the pathway that allows generic drugs to come to market.

Acting FDA Commissioner, Stephen Ostroff, M.D.The generic drug sector has been enormously successful, growing from about 40 percent of drugs dispensed about 20 years ago to 88 percent today. And the cost savings have been enormous – approximately $1.68 trillion from 2005 to 2014 alone.

As my colleague Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER) at FDA, said in Congressional testimony, FDA is currently working to efficiently process and approve generic drug applications, at record or near-record levels, so when drug patents expire, less expensive generic options are available.

What’s helping FDA keep up that pace of approvals is the added resources that FDA and industry agreed to several years ago in the Generic Drug User Fee Amendments (GDUFA), part of the law passed by Congress known as the Food and Drug Administration Safety and Innovation Act of 2012. With this funding, we were able to hire and train over 1,000 new employees, develop an updated informatics platform to support our review program, and reorganize our generic drug office. Now, after several years of building a modern generic drug review process, FDA is on track to achieve the kind of success this legislation envisioned.

Today FDA is achieving – and in some instances surpassing – important GDUFA goals, including our approval of the ‘first generic” versions of an innovator drug.

generic drug chart

Generic Substitutions & Annual Savings

Although potential first generics constitute only a small percentage of our overall workload, they are very important for the market. Over the past three years, we have approved hundreds of first generics for over 200 new drug products. How? We made substantial program improvements. We solicited nationwide technical input from outside experts and organizations; issued a public-facing, transparent prioritization policy; formed a team to expedite the review of first generics; trained review staff; and enhanced our computer systems to streamline the process.

We’ve also eliminated our filing backlog of ANDAs. In August 2014, there were more than 1,100 applications that had not been reviewed for an initial filing decision. Today there is no backlog.

The cumulative result of our efforts is a huge increase in the productivity of the generics program. We ended 2015 at a new monthly high of 99 generic drug approvals and tentative approvals in December.

Finally, FDA is undertaking major changes in quality regulation so the public can be confident that we’re holding generic drugs to the same standards as brand drugs, no matter where in the world they are manufactured or tested.

All of us at FDA are extremely proud of what we’ve accomplished in implementing GDUFA. In the first two years of the program, we substantially enhanced our ANDA review program. Now we’re cranking it up. There will be up months and down months, but the overall trend will be one of continuing increases in output. More approved generics, if marketed, can further expand patient access to quality, affordable medicines.

We are currently engaged in discussions with industry and the public regarding the development of the second generation of GDUFA, which we call GDUFA II. GDUFA II is scheduled to begin in 2017. We welcome the opportunity which GDUFA II offers to build on our success, and make significant program improvements. Our goal is to bring safe, effective, high quality, affordable generics onto the market. This will benefit the health of every American.

Stephen Ostroff, M.D., is Acting Commissioner of Food and Drugs

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