Responding to increased criticism from Congress, the pharmaceutical industry announced a set of voluntary guidelines aimed at governing the way drugs are advertised to consumers.
The "guiding principles" recommend, among other things, that drug companies submit television ads to the Food and Drug Administration before they are broadcast and that risk and safety information be presented in clear, understandable language.
The guidelines, developed by the Pharmaceutical Research and Manufacturers of America, or PhRMA, a Washington, D.C., trade group that represents the industry, also recommend that drug companies work to educate health-care professionals about new products approved by the FDA for a certain time period before broadening outreach to consumers. A specific time period, however, wasn't established. Bristol-Myers Squibb Co. already said it will impose a one-year moratorium on consumer advertising following the launch of a new product.
Senate Majority Leader Bill Frist of Tennessee, who is also a heart surgeon, recently called on the industry to impose a two-year advertising moratorium for new products. While Sen. Frist said he "welcomed" the industry's effort to revamp its advertising practices, he urged individual companies to consider the two-year moratorium.
Billy Tauzin, the head of PhRMA and a former congressman from Louisiana, said it didn't make sense to impose a fixed moratorium because consumers should be more quickly informed about a new live-saving cancer drug than a medicine that treats "the sniffles." He credited Sen. Frist and other lawmakers for moving the industry to agreement on the principles, which have been under discussion for more than a year. Twenty-three companies -- including Eli Lilly & Co., Merck & Co., Schering-Plough Corp., Pfizer Inc. and GlaxoSmithKline PLC -- have said they would adhere to the principles.
"If the ads don't get better, we'll hear about it," Mr. Tauzin said. The PhRMA guidelines go into effect on Jan. 1, 2006, but most companies said they would immediately start making appropriate changes to their consumer-advertising practices.
The guidelines also call on companies to eliminate "reminder" ads that typically carry little discussion of the risks and benefits of products.
Mr. Tauzin said PhRMA will establish an internal office to receive comments from the public and health-care professionals about consumer ads. He also said he would convene an independent review board in early 2007 to review the effect of the guidelines and see if they need updating.
Eli Lilly said yesterday that it would limit advertising for Cialis, an erectile-dysfunction drug it markets with Icos Corp., to television programs that are unlikely to be viewed by children, and won't advertise during major sporting events like the Super Bowl. Karen Katen, Pfizer vice chairman, said the company would limit advertising for its erectile-dysfunction drug Viagra to appropriate audiences. PhRMA's guidelines call for all products to be marketed to the appropriate audience.
William Weldon, chairman of PhRMA's board and chairman of Johnson & Johnson, said most companies already discuss television ads with the FDA before they air. He said the intention is that companies give the FDA plenty of time to comment before an ad airs. The FDA wouldn't necessarily sign off on the ads. "It's the intention ... that people wouldn't go in and submit something on a Tuesday and air it on a Wednesday," he said.
Separately, The Wall Street Journal reported Tuesday that the Food and Drug Administration could announce soon that it would examine its drug-advertising policies, which could lead to tougher regulations. The agency loosened direct-to-consumer ad rules in 1997, opening the door for the current flood of drug advertisements. Spending by the drug industry on ads rose to $4.1 billion last year from $2.5 billion in 2001, according to TNS Media Intelligence, which tracks ad spending.
Many consumer groups, including Public Citizen, said that the FDA should be given more resources and power to regulate consumer ads, and that the pharmaceutical industry shouldn't be trusted to police itself.
"Presubmission of broadcast ads could be a good thing," said Rob Schneider, director of Consumers Union's prescription-drug overhaul effort. "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."
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