FDA Releases Proposed Guidelines for Direct-to-Consumer Print Advertisements for Prescription Drugs
The FDA on Wednesday issued proposed voluntary guidelines that would encourage pharmaceutical companies to list the potential side effects in non-technical language and in larger print in direct-to-consumer print advertisements, the Wall Street Journal reports. Under the guidelines, which will remain open to public comment for 60 days, pharmaceutical companies could include the three to five most common, nonserious potential side effects in the ads, rather than the technical descriptions of all potential side effects required for product labels; however, the ads would "still have to provide all of the warnings, contraindications and major precautions," the Journal reports. The guidelines also would allow pharmaceutical companies to exclude detailed dosage information from the ads (Wilde Mathews/Steinberg, Wall Street Journal, 2/5). According to FDA research, 73% of consumers do not read the "blocks of scientific jargon" in print ads that list potential side effects of prescription drugs, the Boston Globe reports. FDA officials hope that the guidelines lead to ads that allow more consumers to read and comprehend the potential side effects of medications (Rowland, Boston Globe, 2/5). FDA Commissioner Mark McClellan said, "The general idea from all our research is that less may be more," adding, "The goal here is to make sure the FDA is doing all we can to make sure prescription drug promotion is as clear as possible. If we're going to have advertising, people must come away with a clear sense of what the risks and benefits are."
The FDA also proposed to revise regulations on "reminder ads" or "bookends," the New York Times reports. Under FDA rules, television ads that promote prescription drugs by brand name but do not specify the conditions that they treat do not have to list the potential side effects of the medications. However, according to the Times, some pharmaceutical companies have "capitalized" on those regulations by "closely preceding or following" the ads with separate ads that discuss the need to treat certain conditions but do not name specific medications; such ads also do not have to list the potential side effects of the treatments. Under the proposal, the FDA would consider "regulating bookends, possibly using criteria like how much time separates the two types of ads" and whether consumers consider them related or "perceptually distinct," according to the Times. In addition, the FDA released a proposal that calls for rules for ads for medical devices; the proposal would require such ads to include a "prominent statement of substantial product risk" and direct consumers to additional information, the Times reports (Elliott, New York Times, 2/5). According to the Newark Star-Ledger, the FDA proposals are "an outgrowth of the burgeoning" business of direct-to-consumer prescription drug ads. Spending on such ads increased from $2.71 billion in 2002 to $2.74 billion between January and October 2003, according to the market research company Verispan (Silverman, Newark Star-Ledger, 2/5).
Pharmaceutical industry officials said that they support the FDA proposals, the Globe reports (Boston Globe, 2/5). "We're supportive of any ways to get clear information about our products to consumers," Robert Clark, vice president of regulatory affairs for Pfizer, said (Wall Street Journal, 2/5). Adonis Hoffman, senior vice president and counsel at the Washington, D.C., office of the American Association of Advertising Agencies, said that the proposals are "enlightened" and "are exactly the kind of leadership we like to see from a regulatory agency." However, Rep. Henry Waxman (D-Calif.) said that proposed guidelines for print ads "could open the door to abuse" or "misleading" ads (New York Times, 2/5). Waxman last week said that the FDA has allowed more misleading prescription drug ads to air "unchallenged" by fewer enforcement actions. According to a report compiled by the Democratic staff for the House Committee on Government Reform at the request of Waxman, the FDA in 2003 issued 24 citations to pharmaceutical companies for false or misleading ads, a 75% decrease from 1999 and 2000 (California Healthline, 1/30). McClellan said that the guidelines would allow the FDA to "focus on egregious violations instead of manufacturers that just did not understand the rules," the AP/Washington Times reports (AP/Washington Times, 2/5).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.