FDAnews Drug Daily Bulletin
Sept. 13, 2012 | Vol. 9 No. 180
Pharma Blog Watch
Changes When Going Over the Counter (Pharmalot blog)
Once a prescription medication is switched to OTC status, another sort of switch takes place — regulatory oversight of the advertising shifts from the FDA to the FTC. “An analysis of 133 print and broadcasting ads for four different medicines that were switched to OTC sales found that, after the switch, 62 of 64 ads, or 97 percent, described benefits compared with 57 of 69, or 83 percent, during the period when the drugs were available only by prescription,” blogger Ed Silverman writes. “However, differences also existed in the presentation of potential harms.” With one exception, 70 percent of the medicines during the prescription-only period listed adverse events compared to 11 percent following the OTC switch, Silverman adds.
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