Building pharma's future

v What's New?

Introducing "Noteworthy..."

We know that sometimes it's the little things that have the biggest impact. So we've created a virtual bulletin board called "Noteworthy..." to share bits of information we've come across that we hope you'll find useful and will get you thinking, inspire you to see things from a different perspective ... or maybe even just make you laugh.

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v Sound Off

  Should FDA "complete response" letters be made public?

Trista Morrison, journalist at BioWorld Today, argues that making "complete response" letters public could benefit pharmas as much as it will investors and consumer groups. Pharma has long argued that disclosing the letters, that explain why the FDA won't approve a drug, reveals confidential information and gives competitors an unfair advantage. But in a blog post (see it here), Morrison says making the letters public would eliminate complaints by the industry that "the FDA review process is a black box and they got smacked with some concern they didn't see coming."

"If complete response letters were made public, and everyone could learn from the FDA's feedback," she writes, "management might be able to better anticipate what issues the FDA will raise and avoid wasting money on the same mistakes another company has already made."

Sound off at soundoff@pharmaphilos.com

 

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Pharma Philos considers contributed articles for publication from respected members of the pharma and vendor/consulting communities. To offer your own insight to the Philos Forum, please forward abstracts or completed articles for consideration to forum@pharmaphilos.com.