A Changing Role For The FDA’s Bob Temple

2 Comments

bob-templeLong considered to be overseer of important regulatory matters, Temple has been promoted to Deputy Director for Clinical Science within the agency’s Center for Drug Evaluation & Research, according to The RPM Report, which notes the shift gives Temps broader scope on technical scientific issues

Although Temple will remain Acting Director of the Office for Drug Evaluation I, which includes the divisions for cardiovascular and renal, neurology and psychology drug products, he’ll have a reduced role on drug promotion and marketing issues. And this happens just as the FDA tries to figure out how to regulate promotion of medical products on the Internet and in social media, RPM points out.

His departure from the Office of Medical Policy, which oversees the Division of Drug Advertising, Marketing and Communications, is seen as a mixed bag by drug marketers. This could cause more flexibility on regulatory thinking, but RPM says some marketers fret they are losing a “reliable and persuasive advocate for sound regulatory policy.” Rachel Behrman will take Temple’s position as Acting Associate Center Director for Medical Policy and Acting Director, Office of Medical Policy.

[Fyi, Ed Silverman is an editor at the Pink Sheet, which is published by the same company that publishes the RPM Report]

Jump to comments

Share

Comments

  1. Hopefully, some of our FDA folks will share their perceptions of the significance of this move.

  2. Based on the Pink Sheet (which I only saw today because it was sent as a “free sample”), the big issue is that it takes Temple out of direct supervision of DDMAC, and thus out of current FDA discussions of off-label marketing.

    Given recent history, that makes this a more interesting story, although its policy implications appear unclear.

Leave a Comment


- 7 = two

Subscribe

RSS Feed

Comments feed for this post only.

Clear

Clear

All rights reserved, UBM Canon. Copyright, UBM Canon.

Thanks for trying out the new Pharmalot printing tools. If you're got any suggestions for how we can help you print better, please let us know by clicking on the contact link at http://www.pharmalot.com/