FDA

A Rare Look Inside the FDA’s Drug Approval Process

If you don’t know it already, I am a fan of Lisa Gualtieri and her blog: Lisa Gualtieri’s Blog on Health. Lisa is an Assistant Professor at Tufts University School of Medicine in the Health Communication Program. She teaches Online Consumer Health, Social Media and Health, and Digital Strategies for Health Communication. Recently I wrote a post about an Mobile Health Design Course that she will be teaching beginning May 23.

Drug Sponsors and The Agency: Yesterday Lisa published a blog post detailing her experience as a new member and Consumer Representative to the Arthritis Advisory Committee (AAC) of the FDA. Lisa’s role is to represent the consumer perspective on issues and actions before the FDA AAC. Lisa’s post gives the reader a rare insider’s view of the drug approval process. She actually shares some of the exchanges she had with drug companies (Pfizer and Regeneron), her perspective on the preparation and presentation by the drug sponsors, and the differences in language and thinking between the FDA and the Sponsors.

As part of my firm’s life sciences practice, I’ve done work with pharmaceutical and biotech firms for years. Yet I have never been privy to the details of this part of the drug approval process. For me, it was fascinating to read Lisa’s account. In her usual thoughtful manner, here’s how Lisa summed up her experience:

“The meetings were fascinating and I appreciated the public nature of the process, including making all materials available to the public before the meeting, opening it to the public in person and through streaming, and providing time for people like Jan Wyatt, RN, PhD to speak. I saw the meetings as a milestone in a long chain of events that started with years of research and clinical trials. The meetings were not the end since the FDA needs to make decisions based on the AAC recommendations and then work with the sponsors on their next steps to further ensure efficacy and safety.

I am honored to be part of this committee. Most of all, I have the deepest respect for the professionalism and knowledge of my fellow committee members, the agency, the sponsors, and the public who participated. Together I believe we have the shared goals of bringing new treatments to patients without compromising safety.” (Source: Lisa Gualtieri’s Blog on Health)

I encourage you to read Lisa’s post in its entirety at http://lisaneal.wordpress.com/2012/05/14/fda/.

3 comments on “A Rare Look Inside the FDA’s Drug Approval Process

  1. Thank you so much, Dan!

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