"Approved" With the Stroke of a Pen - Commentary on the FDA Modernization Act of 1997

Madeleine M. Jester, RN, JD

Marketing folks like to say that their products are "approved", because they believe it enhances the credibility (and hence the value) of their products. It's a little like having a "Good Housekeeping" seal.

However, prior to 1997, the Food, Drug and Cosmetic Act prohibited drug companies from saying their drugs were approved. Section 301 (l) stated that "The using, on the labeling of any drug or device or in any advertising relating to such drug or device, of any representation...that approval of an (FDA)application...is in effect..." is prohibited.

It seems like a small point, but this prohibition has been the bane of many a drug and device marketer over the years. The FDA, doctors, speakers, and even newspaper reporters could use the term. Until this year, however, the makers of prescription drugs and devices could not.

All that changed on November 21, 1997, with the signing into law of the FDA Modernization Act. With the stroke of a pen, section 301 (l) was deleted from the Food, Drug and Cosmetic Act. Now, the manufacturers of drugs and devices can say their products have been approved by the FDA.

A word of caution is in order, however. The FDA, in reviewing new drug and device applications, just evaluates whether or not the products appear to be safe and effective for their intended uses. Therefore, company salespeople must be careful that permission to say "approved" by the FDA doesn't turn into making more claims for the product than the labeling allows.

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