Law and Order Takes on the FDA - Oct 22, 2007

David Markovitz here with another personal story.

Last week I was watching my favorite TV show, Law and Order: Criminal Intent. It’s the one with quirky Detective Goren, a modern day Columbo. The plot revolved around a counterfeit mouthwash contaminated with DEG (diethylene glycol). An FDA Field Investigator discovers the contaminated mouthwash after children die and writes a memo to his superiors recommending an immediate recall. The FDA Regional Director shreds his copy to protect his college buddy, now the head of the pharmaceutical company targeted by the counterfeiters. The Deputy Director has her eye on the Director’s job, murders the Field Investigator using a counterfeit asthma inhaler (with no active ingredient) and tries to frame her boss in order to get his job. Of course, the detectives figure it out and arrest the Deputy Director of the FDA.

Now the Real World FDA
The FDA has been pummeled by the media and members of Congress in the past three years for a series of contaminated products, product withdrawals, recalls, a convicted Commissioner, the plan to close and consolidate labs, and other issues. Now a popular television show portrays the FDA in the worst possible light.

What Can We Expect from the FDA?
Expect FDA inspections to continue to be tough and get even tougher as they fight this image of incompetence, ineptness, and not caring for the consumer. In the TV show, the only FDA rep who cared for the consumer ended up dead.

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