03 August, 2005 15:11 GMT
The new prescription-drug advertising guidelines fail to deliver a single guarantee for consumers, says Sen. Chuck Grassley, R-Iowa.
Twenty-three drug companies agreed Tuesday to new guidelines for consumer drug ads, but industry critics assailed the pledges as weak and unenforceable.
The guidelines, while expected, include several surprises, including an end to "reminder" TV ads that name a drug but not its use or risks.
The companies also pledged to:
Submit TV ads to the
Food and Drug Administration before they run, which many companies already do, so the agency can flag potential problems. The companies don't have to wait for FDA approval to run the ads.
Restrict ads for drugs such as those for sexual dysfunction to TV shows "reasonably expected" to draw an 80% adult audience.
Educate doctors about new drugs before starting consumer advertising. The guidelines don't say how long drugmakers should wait, because each drug is different, says Billy Tauzin, CEO of the Pharmaceutical Research and Manufacturers of America, which wrote the guidelines.
'Important First Step'
Senate Majority Leader Bill Frist, R-Tenn., has proposed a two-year moratorium on consumer ads for new drugs, and
Bristol-Myers Squibb has said it will wait one year.
Frist, in a statement Tuesday, said he hoped individual companies will set their own moratoriums.
Still, he said the guidelines -- and the FDA's intent to review its consumer drug advertising guidelines -- "mark an important first step."
Guidelines Fail to Deliver?
Sen. Chuck Grassley, R-Iowa, was less impressed, saying in a statement that the guidelines failed to deliver "a single guarantee for consumers." And Sidney Wolfe of the consumer group
Public Citizen said they contained "nothing that really is meaningful."
Both Grassley and Wolfe say tougher FDA enforcement of existing rules is needed. The FDA has cited 21 drug ads for running afoul of regulations so far this year. In all of 2004, it cited 23 but acted against many more before 2000.
The FDA is expected soon to solicit public input on regulating drug ads, says Scott Gottlieb, a deputy FDA commissioner. That could be a first step to new guidance or rules.
The companies will review current ads and are expected to make changes by year's end. An independent panel will monitor the industry's performance.
Contributing: Julie Appleby
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