23 Drug Companies Agree to New Guidelines on Advertising

The Pharmaceutical Research and Manufacturers of America on Tuesday released the final version of voluntary guidelines for direct-to-consumer prescription drug advertisements, but critics called the guidelines inadequate, USA Today reports (Schmit, USA Today, 8/3). The guidelines, released in draft form in July, seek to eliminate "misleading advertising that can lead to unnecessary prescriptions," according to the Baltimore Sun. Since PhRMA approved the final version of the guidelines on Friday, 23 pharmaceutical companies -- such as Johnson & Johnson, Merck and Schering-Plough -- have agreed to follow them (Rockoff, Baltimore Sun, 8/3). Other pharmaceutical companies that have agreed to follow the guidelines include Eli Lilly, Pfizer and GlaxoSmithKline (Corbett Dooren, Dow Jones/Wall Street Journal, 8/3). Under the guidelines, the pharmaceutical companies have agreed to:

• Restrict DTC ads for erectile dysfunction and similar medication to television programs "reasonably expected" to attract an 80% adult audience;
  
  
• Spend an appropriate amount of time, not specified in the guidelines, to educate physicians about new medications before the launch of DTC ads for the treatments;
  
  
• Submit TV ads to FDA before they air -- a practice that many companies currently follow -- but the companies do not have to wait for agency approval before they begin to air the ads;
  
  
• End the use of "reminder" TV ads that name medications but do not provide details on their uses or safety risks (USA Today, 8/3);
  
  
• Include in DTC ads clear language on the safety risks and benefits of medications;
  
  
• Make claims about medications in DTC ads only when they are supported by substantial medical evidence (Richwine, Reuters/Houston Chronicle, 8/2);
  
  
• Indicate when medications require a prescription and are not available over the counter;
  
  
• Remain consistent with label requirements established by FDA; and
  
  
• Update DTC ad campaigns to highlight "new and reliable information" on the safety risks and benefits of medications (CQ HealthBeat, 8/2).

Weldon Comments
William Weldon, CEO of J&J and chair of the PhRMA board, released the guidelines on Tuesday at a news conference in Dallas. Weldon said that the guidelines "go well beyond what is mandated under regulations," adding, "This is an important step in the transformation of our industry" (Silverman, Newark Star-Ledger, 8/3). Weldon said, "We will use advertising not only to promote new medicines but also to educate consumers about health and disease" (Japsen, Chicago Tribune, 8/3). He added, "While direct-to-consumer advertising has drawn fire from some quarters, and some of this is well-deserved, it is a powerful tool for informing consumers" (Higgins, Washington Times, 8/3).

Tauzin Comments
Tauzin said, "This is a code designed to take campaigns to sell products into a realm where they are more educational, more balanced, more complete, more determined to make sure that doctors and patients have a responsible dialogue" (Reuters/Houston Chronicle, 8/2). He added, "We are in a free-speech area. Voluntary codes tend to be the best way to handle these things. So what we've done is set up a good, strong voluntary code" (Alonso-Zaldivar, Los Angeles Times, 8/3). Although PhRMA will not revoke membership from pharmaceutical companies that do not follow the guidelines, Tauzin said, "We will have a healthy discussion with companies that sign up with the code of conduct and do not follow it" (Washington Times, 8/3).

Reaction From Pharmaceutical Companies
Eli Lilly officials on Tuesday said that the company will limit ads for the ED medication Cialis to TV programs that likely will not attract children and will not air such ads during major sporting events. Pfizer Vice Chair Karen Katen said that the company will limit ads for the ED medication Viagra to appropriate audiences (Dow Jones/Wall Street Journal, 8/3). "We would not be on the Super Bowl," she added (Henderson, Boston Globe, 8/3). GSK officials said that the company will "comply as soon as possible" with the guidelines (Ginsberg, Philadelphia Inquirer, 8/3). Takeda Pharmaceuticals North America officials said that the company will delay TV ads for the new insomnia treatment Rozerem and take time to educate physicians about the medication. "The last thing we want to do is drive patients into physicians' offices asking them about a new product that physicians aren't necessarily going to have all of the recent information on," Takeda spokesperson Matt Kuhn said (Chicago Tribune, 8/3).

Frist, Grassley Reaction
Senate Majority Leader Bill Frist (R-Tenn.) called the guidelines an "important first step" but said that they should have "gone further." According to the Sun, Frist had proposed a requirement that pharmaceutical companies wait two years before they launch DTC ad campaigns for new medications (Baltimore Sun, 8/3). Frist said, "I hope individual pharmaceutical manufacturers will seriously consider such a measure" (Boston Globe, 8/3). Senate Finance Committee Chair Chuck Grassley (R-Iowa) said that the guidelines do not "deliver a single guarantee for consumers," adding, "It doesn't make sense to rely on drug companies to police themselves" (Philadelphia Inquirer, 8/3). Grassley said that FDA "needs to stop dragging its feet and start exercising its authority to closely monitor the marketing of pharmaceuticals."

Additional Reaction
Scott Gottlieb, chief deputy FDA commissioner, said that the agency supports the guidelines, adding, "I think the industry itself, issuing principles like it did today, is an important step. Clearly they're expressing a willingness to try to police themselves" (Saul, New York Times, 8/3). American College of Physicians President C. Anderson Hedberg said, "The fact that drug companies are giving the ads to the FDA for approval is a very good step." Linda Golodner, president of the National Consumers League, said, "We are encouraged that PhRMA has come up with these principles and that some of them call for the basic information we have been calling for over the years. But I am not quite sure how the accountability is going to work" (Washington Times, 8/3). American Medical Association Trustee Edward Langston called the guidelines a "good first step." John Kamp, director of the Coalition for Healthcare Communication, praised the provision in the guidelines on reminder ads (Newark Star-Ledger, 8/3). Marc Scheineson, a former FDA attorney who currently represents pharmaceutical companies, called the guidelines "a platform on which you can build," adding, "You have to start somewhere with principles that can get industry consensus and compliance" (Los Angeles Times, 8/30.

Criticism
According to the Washington Times, critics of the pharmaceutical industry "argued that the guidelines are voluntary, and they expect marginal enforcement of the rules" (Washington Times, 8/3). They also said that the guidelines "merely duplicate what is already required" by FDA and only seek to avoid additional restrictions imposed by Congress, the San Francisco Chronicle reports. Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "It's a frantic, desperate attempt to make their image improve and fend off legislation" (Tansey, San Francisco Chronicle, 8/3). He added that the "guidelines are a meaningless attempt to fool people into believing the guidelines are stronger than they really area" (Philadelphia Inquirer, 8/3). Wolfe said, "PhRMA's latest campaign of industry self-regulation via the guidelines ... is both dangerous and, like previous industry efforts, doomed to failure, since selling drugs will always trump obeying the law" (New York Times, 8/3). Wolfe also recommended a "significant increase" in FDA enforcement against DTC prescription drug ads that "make false claims," CQ HealthBeat reports (CQ HealthBeat, 8/2).

Other Criticism
Rob Schneider, director of the prescription drug reform effort at Consumers Union, said that the guidelines "fall short" (Baltimore Sun, 8/3). He added, "Presubmission of broadcast ads could be a good thing. But the problem has been a lack of resources at the FDA. If drug makers are serious, they will hold ads until the FDA has had the chance to actually review them" (Dow Jones/Wall Street Journal, 8/3). According to the Inquirer, Grassley has proposed legislation that would require FDA to approve DTC prescription drug ads before they air (Philadelphia Inquirer, 8/3).

Implications, FDA Review
According to the Los Angeles Times, "It was not clear ... whether the industry's relatively modest steps would be enough to hold off growing complaints by some lawmakers, consumers and physicians" about DTC prescription drug ads (Los Angeles Times, 8/3). Frist said that he will "continue to evaluate whether legislative remedies are necessary to put patient safety first and help control prescription drug costs" (San Francisco Chronicle, 8/3). Meanwhile, an FDA spokesperson "confirmed a report" in the Wall Street Journal on Tuesday that the agency "plans to review its advertising policies" (Newark Star-Ledger, 8/3). The Wall Street Journal reported that FDA plans to announce a review of DTC prescription drug ads in response to agency research on concerns raised by physicians and consumers (Kaiser Daily Health Policy Report, 8/2). FDA spokesperson Suzanne Trevino said, "We expect to solicit comments from consumers, from experts on advertising and health care professionals on this important topic." She did not indicate when FDA will begin the review (Webb Pressler, Washington Post, 8/3). According to the AP/Las Vegas Sun, an FDA review of DTC prescription drug ads "could lead to tougher regulations" (Agovino, AP/Las Vegas Sun, 8/2). Frist also has requested a study of the issue by the Government Accountability Office (Webb Pressler, Washington Post, 8/3).

The guidelines are available online. Note: You must have Adobe Acrobat Reader to view the guidelines.

Post Column
The guidelines are a "credible first step in solving" some of the problems related to DTC prescription drug ads, but they will do little to "curb the growth in unnecessary spending," columnist Steven Pearlstein writes in a Post opinion piece. According to Pearlstein, what is "needed ... is some sort of test that would limit or eliminate advertising for drugs ... that offe[r] little or no advantage over cheaper generics." Drug advertising seeks to "artificially create the impression in the minds of consumers" that a product is a solution to "some widespread, unmet medical need," Pearlstein writes, concluding that "that ruse would quickly be exposed if drug companies had to put their products through a reasonable and independently administered cost-benefit analysis before marketing them directly to the public" (Pearlstein, Washington Post, 8/3). Pearlstein is scheduled to answer questions about the guidelines in a Washingtonpost.com online chat Wednesday at 11 a.m. ET. A transcript of the discussion will be available online.

Broadcast Coverage
APM's "Marketplace" on Tuesday reported on the guidelines. The segment includes comments from John Abramson, physician and author of the book "Overdosing America"; Bruce Lehman, president and CEO at medical marketing agency Lehman Millet; and Tauzin (Palmer, "Marketplace," APM, 8/2).

The complete segment is available online in RealPlayer.