Now on Pharmaceutical Processing
California ePedigree Push to 2015 – What does it mean? Comments
From a vision to a vial in 12 months - Process development and... Comments
Addressing the Challenges Contract Manufacturing Organizations are... Comments

Subscribe to Pharmaceutical Processing
 


































 
Buyer's Guide – Product News

Packaging > Blister / Thermoforming Equipment / Supplies >
PAPER, FOIL FILM LAMINATIONS

Blister Foil Seals to Honeywell’s ACLAR® Barrier Films
Hueck Foils L.L.C., April-07
Child-Resistant Blister Foils Available In Peelable And Peel/Push Formats
Hueck Foils L.L.C., December-06
Foil Barrier Laminate Ideal For Cleanroom And High Sterility Applications
ITW Richmond Technology, October-06
Pressure Indicating Film Aids In Packaging R&D
Sensor Products Inc., June-06
Pressure Indicating Film Aids In Packaging R&D
Sensor Products Inc., June-06
Short-Run Blister Foil Printing Available For Both Flexo And Rotogravure In A Wide Range Of Configurations And Options
Hueck Foils L.L.C., December-05
Foil Offers Ultra-High Barrier Performance For Pharmaceutical, Medical Device Applications
Ampac Flexibles, March-05
High-Security Foil
Hueck Foils L.L.C., July-03

 
Small Doses

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.

More Small Doses
Digital Library




























Bioscience Technology Chromatography Techniques Drug Discovery & Development Laboratory Equipment Pharmaceutical Processing R&D Scientific Computing
Advantage Business Media © Copyright 2008 Advantage Business Media
Privacy Policy | Terms & Conditions | Advertise With Us