The "Risk-Only" Landing Page Requirement: Can We Get FDA to Adopt FTC's Thinking and Drop This Rule?

One of FDA's Ten Commandments -- the FIRST one, in fact -- states:You shall have no other regulatory agencies before Me.Several people have asked me, "John, what other agency could pharma worship before FDA?"Glad you asked.The Federal Trade Commission (FTC) also regulates product advertising. The FDA, however, as per its first commandment, lords it over prescription (Rx) drug advertising, whereas the FTC regulates advertising of other health products, including supplements and over-the-counter (OTC) drugs. FDA, however, regulates what is claimed on the labels of OTC drugs.Whatever. The main point is that FDA regulates advertising of Rx drugs and FTC regulates advertising of OTC drugs, most, if not all, of which began life as Rx drugs.FDA and FTC regulatory guidelines are often very similar. In fact, when the FTC issued its guidelines for promotion via social media in March, 2013, I thought FDA's social media guidelines would be similar to FTC's.No such luck!The following table is a handy side-by-side comparison of the two approaches (FDA v. FTC).Read more »

Source: Pharma Marketing Blog - July 23, 2014 Category: Pharma Commentators Tags: #fdasm Drug Safety FTC guidelines one-click rule regulations social media Source Type: blogs