Know Your Audience

Wednesday, April 22, 2009

Monday and Tuesday, MyRAQA was attending a conference on Partnership in Personalized Medicine in the IVD industry.  I sat on a panel the first evening and had a chance to meet some interesting people and hear about some great projects.

I also had a chance to see some executives put themselves at some risk, probably without realizing it.  Several times during the first day, people stood up during the session and lambasted FDA, criticized reviewers and made bold pronouncements of their FDA-related strategies and gambits.

I have to hope that they might have thought twice about some of these choices if they had realized that FDA was attending the conference.  It wasn't exactly a secret... OIVD Deputy Director Gutierriez was one of the featured speakers. Dr. Gutierrez wasn't scheduled to speak until the second day... but that doesn't mean he wasn't in attendence on the first day.

Just because an audience is mostly composed of fellow executives does not mean that you are speaking in confidence or that you should discuss things you wouldn't normally say in front of FDA.

So in the spirit of public service, here's some free advice about discussing FDA at public meetings:

  1. FDA regularly attends public meetings and industry events.  They do so out in the open, yet not necessarily in a way that is conspicuous.

  2. When you speak at a public meeting, you are making public statements.  FDA has the authority to review public statements regarding regulated products.  Companies can (and have) landed themselves in trouble for their public statements.

  3. OIVD is not a very large place.  If you picked a half dozen people at random from OIVD's office, chances are at least one of them will participate in a review of one of your products at some point.

  4. FDA reviewers and managers are people too.  They're doing a difficult, important job for not very much money.  As a group, they deserve more respect than they typically get.  Bashing them at a meeting is not a great way to demonstrate that your compnay takes the regulatory process seriously.

Industry meetings and shows can be a great way to keep current with what's going on in the rest of the IVD community.  Just keep in mind that FDA is part of this community too and like any small community, word can get around quickly.

Tags: Best Practices, FDA, FDA 101, Public Statements

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