You Can’t Fight City Hall - Pharmaceutical Processing

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You Can’t Fight City Hall

by Mike Auerbach, Editor

Mike Auerbach, Editor Pharmaceutical Processing

Throughout my life I’ve been to countless sporting events – from local soccer matches my kids have been involved in up to major league events in almost every sport. If there is one thing I have learned over the years it’s that you can’t win an argument with a referee. Whether it’s an overzealous parent on the sideline, a student/athlete on a high school field or a professional athlete in a big city stadium – arguing with a referee or an umpire will get you no where. Yet people continue to do so - and frankly I don’t understand why. During a sporting event – the referee is the LAW out there on the playing field – and all of his or her decisions are final - so why bother fighting city hall? And yet many people continue to try – only to find themselves being thrown out of a game; or in the case of an overzealous parent – asked to leave the sideline.

A similar situation came to light recently when a major pharmaceutical manufacturer was warned by the FDA that they were in violation of the law by marketing over-the-counter pain relievers with unproven health claims.

The agency allows traditional pain relievers to be sold over-the-counter without review, as long as they include standard directions and labeling for consumers. But the FDA said the products from the company in question overstepped those regulations by claiming that the added ingredients in each medicine help fight specific diseases.

In general, the FDA discourages firms from packaging drugs with dietary supplements because it gives the impression both have been evaluated by the FDA, when in fact, the agency only regulates drugs.

What were they thinking? Going back to my sport analogy – the FDA is the referee and they make the rules – so what did this company hope to accomplish? In this case you can't fight city hall or the FDA and the repercussions are more severe than a simple red card.

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Viewing 2 User Comments	Add a Comment

FDA/Referees 11/12/2008 8:35:43 AM
As usual, your editorials are so true to life. I think, no, I know, every reader will agree with your analogies.

Fighting City Hall 12/19/2008 5:39:28 AM
Your commentary is to the point and it is a great analogy. The same principle applies in many aspects of our lives. Specifically about the FDA, Yes, the agency is the referee, and usually is a good and a fair referee. However, in my view, it is putting a lot of attention, efforts and resources to look at the drugs manufactured within the US and Puerto Rico, and to the marketing promotions and claims within our market; and this is quite important. However, the referee is not devoting enough resources and quality time to oversee and monitor the manufacturers, and the many OTC and prescription drugs produced abroad, including in Canada. Over 40% of the products dispensed in our pharmacies today, come from foreign sources, which are being inspected in spans exceeding five years, and not at least every two years, as minimally required. We can be assured that if the FDA starts looking at the products coming from overseas, with the same intensity as they look at the “locals”, it will find a bigger issue and with deeper repercussions for the public health, than the impact of some of the off-label claims we occasionally see.

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