Exciting Developments At The FDA - Annual Meeting Of The American Urological Association

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Jun 2008 - 5:00 PDT

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ORLANDO, FL (UroToday.com) - Dr. Andrew von Eschenbach discussed developments at the FDA. He addressed the FDA mission to protect and promote public health. The FDA has been in existence since 1906. The FDA regulates 20% of everything we consume to include most food, drugs, medical devices, animal feed and drugs, cosmetics and radiation devices. The budget for this is modest at 2.27 billion dollars. The FDA has 10,000 employees. The resources are thus not commensurate with the challenges.

Globalization and advances in science and technology are present challenges at the FDA. There are 295 active US points of entry. This includes food, dietary supplement, drugs, cosmetics, devices and animal food. Drugs are primarily coming from India and China. Their infrastructure is less developed than in the US and the recent news of contaminated heparin from China is an example. FDA notification occurred in January 2008, and they identified a common source in China. 81 deaths occurred and analysis using sophisticated techniques identified contamination with over-sulfated chondroitin sulfate. This was all addressed and corrected in 2.5 months. This has altered the FDA's oversight, to now cover the complete life-cycle of products from production to consumption. Prevention, intervention and response are the new approach. They are launching "FDA beyond our borders" with 5 oversea FDA offices.

Dr. von Eschenbach also addressed whether the pharmaceutical pipeline is drying out due to restrictions. There are fewer applications and approvals for drugs. Their analysis finds that there are fewer products coming on the front end. Next in class drugs, replicating existing drugs account for most of this. First in class drugs, which are new and novel are still increasing. This reflects innovation, which is encouraging. In 2007 there were over 6,000 investigational new drugs submitted. Application quality is the most important factor in application approval and poor quality is costly (on average each additional review cycle delays approval by 11 months, i.e. about $30 million R&D). As such, the FDA is rethinking the business aspect of approval and providing earlier consultation, biomarker qualification, modernized clinical trials suggestions, bioinformatics, implementing good review management principles and post-market active surveillance.

Presented by Andrew von Eschenbach, MD, at the Annual Meeting of the American Urological Association (AUA) - May 17 - 22, 2008. Orange County Convention Center - Orlando, Florida, USA.

Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

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