Efficiency, Effectiveness and FDA All In The Same Sentence?

By Daniel R. Matlis

In the past few years, CDER has made significant changes to advance and facilitate the review of electronic regulatory submissions. These include spearheading projects to standardize information management processes, publish regulations and guidance documents to support electronic submissions, and facilitate the development of information management project proposals, which will benefit the consumer and the pharmaceutical industry.

As evidence of the positive impact of these changes, over 3000 e-CTDs have been submitted to the FDA since the it began accepting them 2 1/2 years ago.

Many of these improvements are the work of the Office of Business Process Support (OBPS) at CDER.   “Through the use of the Project Development Staff and other resources within OBPS we started to develop more specialized experience so that over time we are able to turn around this projects more quickly and with higher quality” said Gary M. Gensinger Director of Regulatory Review Support Staff, OBPS at CDER. He continued “that’s what it’s all about.”

Another key area addressed by OBPS is standards. “It’s not about doing the same thing for the sake of doing the same thing, but trying to find out what’s the best practice” said Gensinger. To my surprise and delight he went on to say ”it’s about finding what is the most efficient and most effective way to move forward, so that what limited resources we do have, we can spend that in the review process”.

The FDA is making a concerted effort to harmonize internally as well as externally to focus as many resources as possible on the “Receive, Review, Report” process.

With all this talk about doing more with limited resources, and looking for the most efficient and effective ways get things done, can regulatory outsourcing offshore be the next step?

 I certainly hope not. Regulatory Oversight is not a function we want to outsource.

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