Congress Needs To Regulate DTC Prescription Drug Ads, Columnist Writes

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 May 2008 - 8:00 PDT

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FDA "had no idea things would get so out of hand" when it relaxed rules governing direct-to-consumer prescription drug advertising in 1997, Los Angeles Times columnist David Lazarus writes. According to Lazarus, the "relationship between doctors and patients has clearly shifted," with patients -- "egged on by marketing-savvy drug firms" -- starting the "discussion of which prescription drug is best for them" without considering a professional diagnosis or the presence of symptoms.

According to Lazarus, DTC ads have "proliferated" since FDA clarified its rules, with spending on DTC advertising more than quadrupling from 1996 to 2005, from $985 million to $4.2 billion. Lazarus notes that a Government Accountability Office report last week found that the number of "advertising materials" from prescription drug companies rose from 6,000 in 1999 to 21,000 in 2007.

Meanwhile, Lazarus notes that GAO found that FDA sent two warning letters related to potential violations of DTC rules to pharmaceutical companies in 2007, compared with an average of 15 to 25 between 1997 and 2001.

Lazarus notes that, at a congressional hearing last week on potential legislation that would establish new standards for DTC ads, American Medical Association President-elect Nancy Nielsen said that most physicians do not like DTC ads because they force physicians to have discussions with patients who want a drug they saw in a DTC ad over a low-cost, generic version or an alternative therapy. Nielsen said, "It takes a lot of time to have that conversation, and it can get a little confrontational." Lazarus concludes that "policymakers need to recognize the obvious and apply greater safeguards" to DTC ads (Lazarus, Los Angeles Times, 5/14).

Opposing Viewpoints
USA Today on Thursday published an opposing view editorial and opinion piece about DTC drug advertising. Summaries of the pieces appear below.

• USA Today: "The government, respecting free speech, should be very wary of interfering with honest advertising of a safe and legal product," a USA Today editorial states. However, the "problem is, the FDA doesn't have the money, the staff or, based on past action, the inclination to strictly police the ads," according to the editorial. USA Today writes, "The industry's reliance on TV advertising is unlikely to diminish for the simple reason that it works," adding, "It can help turn an unknown new drug into a blockbuster or keep an old one on top." USA Today concludes, "That makes it all the more important to have responsible companies, skeptical consumers, tough-minded doctors and -- ultimately -- vigilant regulators" (USA Today, 5/15).
  
  
• James Sage, USA Today: DTC advertising "has become a controversial issue," but "it's important to remember that the decision to remove barriers to pharmaceutical ads has improved patient health, raising awareness of a host of symptoms, conditions and treatment options," Sage, senior director and team leader for Lipitor marketing at Pfizer, writes in a USA Today opinion piece. Sage discusses the marketing of Lipitor, writing that the "idea was to encourage dialogue between patients and physicians." Pfizer has sought to update its advertising campaign for the drug by creating a commercial featuring "a leading pioneer in heart health, Dr. Robert Jarvik," Sage writes, adding, "Unfortunately, the way Dr. Jarvik was presented in these ads created misimpressions and distractions from our goal of encouraging patient and physician dialogue about cardiovascular disease." Pfizer withdrew the ads because of the concerns, Sage says. He concludes, "At a time when heart health continues to be a major concern, educating the public about ways to live longer and healthier must be uppermost in everyone's mind" (Sage, USA Today, 5/15).

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