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March 16, 2007

Fosamax and the FDA

The problems with FDA and Merck regards Fosamax date back 10 years. For example, in July 1997, (see NDA: 20-560), Merck was advised that its marketing tactics for Fosamax contained false information about osteoporosis and that Merck was overstating the population eligible for therapy with Fosamax.

So it seems that selling the drug was more important than getting the facts right.

DDMAC (FDA's division for marketing) ordered Merck to stop the dissemination of this false information.