Frist Calls for Voluntary Moratorium on DTC Advertising for Prescription Drugs
As expected, Senate Majority Leader Bill Frist (R-Tenn.) on Friday called for a voluntary moratorium on direct-to-consumer prescription drug advertising for two years after a drug reaches the market, CQ HealthBeat reports. In a letter to the Government Accountability Office, Frist also requested a study of FDA regulation of prescription drug advertising, prescription drug industry spending on advertising and the advertising's effect on consumer spending, awareness and utilization.
That request "signaled that he may push for tougher agency scrutiny and regulation" of DTC advertising -- a move that might be designed to "force the industry to toughen up the voluntary code as a way of forestalling stricter regulation," according to CQ HealthBeat (CQ HealthBeat, 7/1). Frist said in a statement, "Research evidence indicates this blitz in direct marketing has unwittingly led to inappropriate prescribing, which most importantly can compromise patient safety and care" (CQ Today, 7/1).
He added, "Failure to appropriately monitor and regulate direct-to-consumer drug advertising compromises the safety of the very patients we intend to help. I encourage the industry to allow doctors and patients alike to learn more about the potential benefits and risks of new treatments, so we can be sure we are putting the needs, interests and safety of our patients first."
Frist's announcement followed the Pharmaceutical Research and Manufacturers of America's pledge to create an advertising code of conduct for the industry. PhRMA senior vice president of communications Ken Johnson said the industry will make recommendations about the code later this month.
Johnson added that DTC advertising helps doctors and patients become informed about new medicines. He also said PhRMA's position is that DTC advertisements should be more detailed, educational and informative. Johnson said, "We have had absolutely no discussions with any of our member companies about Sen. Frist's remarks, but as an industry we believe strongly that patients have a right to know" (CQ HealthBeat, 7/1).
Two newspapers examined the pharmaceutical industry's reaction to calls for limits on DTC advertising, on which drug makers spent $4.1 billion last year. According to the Wall Street Journal, drug companies have begun to scale back spending on DTC advertising "as their commercials attract more scrutiny." In total, drug makers spent 2% less in the first quarter of 2005 on advertising across major broadcast networks, magazines and local TV stations than they did in same period one year earlier, according to Universal McCann (Davies et al., Wall Street Journal, 7/5). Drug manufacturers spent 10% less on network television advertising for prescription drugs in the first quarter compared with the same period one year earlier. In that period, sales for all network television advertisements increased 4.2%.
Frank Ginsberg, chair of advertising agency Avrett Free & Ginsberg, said drug manufacturers' spending on network TV ads would continue to decline as they pursue more targeted approaches to advertising, such as the Internet, cable TV and direct mail (Schmidt, USA Today, 7/5). According to the Journal, if a moratorium on DTC drug advertising were implemented, drug manufacturers would "shift their focus back to where it once rested -- on physicians" (Wall Street Journal, 7/5).
The not-for-profit watchdog Washington Legal Foundation recently said that FDA is acting "outside its legal authority" when it sends warning letters to drug companies for advertising FDA considers false or misleading. WLF has said such action shows "disregard for the First Amendment by alleging that materials are misleading with no evidence of how consumers understand them."
WLF chief counsel Richard Samp said, "FDA has never issued regulations on advertising," and FDA has "invented" much of its power in that area. FDA officials declined to comment on the issue (Howard Price, Washington Times, 7/5).
If physicians were more willing to refuse patient requests for prescription drugs advertised on television, "there would be no need" for the American Medical Association "to consider endorsing an ad moratorium," a Newark Star-Ledger editorial states.
However, "it seems that doctors ... just can't say no" when a patient requests a prescription "for a feel-good, wildflowers-blowing-in-the-wind medication seen on television," according to the Star-Ledger (Newark Star-Ledger, 7/2).