Will FDA's efforts to approve generics open the floodgates to approvals?

April 14, 2008

Gary Buehler is the subject of this question and answer style article that addresses issues pertinent to the generic industry.

As the number of applications continues to rise, so do approval times – the average approval in 2007 was 18.9 months, up from 16.6 months in 2006. However, with a $6 million increase in its operating budget this year to expand its lean staff, Gary Buehler, R.Ph., director of the Food & Drug Administration's OGD, told Drug Topics that he is confident that approval times will improve through established and yet-to-be introduced process enhancements.

Drug Topics sat down with Buehler to find out how the process will work as well as the answers to some timely issues facing the generic industry.

We are trying to make our process more efficient and more transparent to the generic drug industry. We want drug companies to know what is expected of them when they submit an application to us so that they can give us a quality application that is more readily reviewable and of course leads to an approval in a faster amount of time. The question-based review is an integral part of the GIVE (Generic Initiative for Value and Efficiency) program. It provides companies with a set of questions, thereby providing us more information not only about the product that they propose to market, but also how they developed this product. This gives us a much better idea of the products that we are reviewing and what went into formulating this product with respect to quality.

What single process improvement has had the biggest impact?

Our triaging of supplements in the chemistry review teams has made a big difference in utilization of resources. These supplements refer to somewhat minor changes in the application that are meant to be made right away before approval. What we have to do with these supplements, though, is make sure that they fall into the right category of changes being affected. In doing that review, many times we can determine that the supplements really do not have to go for formal review and that they can go directly for approval. In previous years we would send all of these supplements to the reviewer for a formal review and this consumed a fair amount of time in the chemistry area. By shortcutting this process, we have saved about 5% to 10% of the chemists' review time that can be devoted to the review of new applications.

Does OGD have any new programs under development?

Right now we are working very closely with our Office of Information Technology to develop what they call DARRTS (Document, Archiving, Reporting, and Regulatory Tracking System). This is an electronic system to receive applications, archive them, and be able to issue decisions all in one electronic format. It will allow us to retrieve parts of the applications and documents that we've generated much more readily. It is essentially an electronic filing system both for the incoming applications- anything we generate such as review or memos on the applications-and the final decisions. We are working with IT to customize this system. We hope this new system will be online towards the end of the fiscal year.

What progress has OGD made in developing standards for generic topicals and nasal sprays, and what universities have you partnered with to develop these standards?

For topical products, we have partnered with the University of Kentucky and the Colorado School of Mines. For inhaled corticosteroids, we have contracts with the University of Iowa and the National Jewish Center to explore different pharmacodynamic endpoints in the evaluation of these products so it makes it easier to determine a product that is bioequivalent to a reference product.

What has been the delay in developing these guidelines?

Research is sometimes challenging to actually find what is the optimum endpoint to use for bioequivalence for these products. Sometimes research isn't a fast process. You have to work with the researchers and come up with what is a good path forward, but sometimes research comes out and sometimes it doesn't.