FDA to Experience: Drop Dead

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Michael Causey
In FDA Regulated Industries

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

I was sitting at my desk the other day hoping the FDA would decide what it needed most today wasn’t a bigger budget or clearer mission, but employees with less experience and knowledge of the industry. I figured their relative ignorance would be just what the agency needed as it tackled some of its toughest challenges in food, drug and device regulation in 2011.

It looks like my prayers were answered.

Fresh off the agency’s “brain drain” in the Bush years where experienced inspectors left the agency in droves, we now have what looks a bit like a mini Saturday Night Massacre FDA-style in the media relations department. Several experienced media relations pros, who knew media and the FDA, were allegedly dumped for younger, less experienced and cheaper personnel. There’s even some whispers that their depth of knowledge was part of the reason they were forced out; some of their bosses were allegedly uncomfortable with personnel who knew more than they did.

Great.

This could have a bad ripple effect for the FDA. Part of the media relations department’s job is to keep media abreast of what the FDA is up to, and, perhaps more importantly, why. Media coverage is the only window the general public has on the agency.

Bad press coverage for the FDA often means more scrutiny on Capitol Hill. And an FDA that is viewed as bungling faces more lawmaker management and the threat of funding cuts.

We’ve heard frustrating stories from many medical device companies who’ve endured an inspection from a relatively green inspector. In some cases, the new inspector covered his lack of knowledge by being tougher in his inspections. I’m not saying that’s the case across the board, but new inspectors aren’t always as effective as more seasoned ones.

The purge in the media relations department at the FDA may not be as serious, but it’s not a good thing.

Let’s see how good the new FDA media relations department is now. I can’t wait to see how they spin losing loads of experience as a positive development.

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  • […] This post was mentioned on Twitter by Meghan and ASSURX, Michael Causey. Michael Causey said: FDA to Experience: Drop Dead http://lnkd.in/pn7a8w […]

  • […] FDA to Experience: Drop Dead Filed Under: FDA Regulated, Michael Causey […]

  • […] As we’ve blogged before, the FDA has suffered from something of a brain drain in the past several years, where some of the more experienced personnel left for greener pastures because they were tired of budget cuts, politics and other issues many felt hampered the agency’s ability to do its job of protecting the public while encouraging innovation. Stone, who left the agency March 25, estimated he’d helped hire and train about 200 new employees in his Texas, Oklahoma and Arkansas territory over the past several years. […]

  • […] written about the tip of the iceberg earlier when it comes to politics and hiring at the FDA. You’ll recall its media office came […]

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