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PhRMA’s Voluntary Advertising Guidelines a Ruse

Aug. 2, 2005

PhRMA’s Voluntary Advertising Guidelines a Ruse

Statement by Sidney Wolfe, MD, Director of Public Citizen’s Health Research Group

Like many misleading direct-to-consumer (DTC) ads, the new Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines are a meaningless attempt to fool people into believing the guidelines are stronger than they really are. Since the fundamental purpose of DTC advertising is to sell drugs, the best way to do so is to overstate the benefits and understate the risks. The 85 percent decrease in actions by the U.S. Food and Drug Administration (FDA) to stop illegal prescription drug ads from 1998 (157 illegal ads stopped) to 2004 (only 24 illegal ads stopped) all but encourages the pharmaceutical industry to persist in its illegal, but successful, drug ad campaigns.

The FDA has had the authority to regulate prescription drug ads for more than 40 years because of failed drug industry self-regulation, but the agency hasn’t done an adequate job. It has too little authority and doesn’t even use the little authority it has.   PhRMA’s latest campaign of industry self-regulation via the guidelines announced today is both dangerous and, like previous industry efforts, doomed to failure since selling drugs will always trump obeying the law.

Three essential changes that, unlike the PhRMA guidelines, would actually make a difference in this serious problem of misleading drug ads include:

1)   A significant increase in FDA enforcement actions concerning illegal ads;

2)   Congressional authorization to impose large fines on companies for violating the drug advertising law and regulations; and

3)   Legal authority to require all TV ads to be approved by the FDA before they air.