"We asked them to immediately stop running the misleading ads and immediately start running corrections for the false perceptions left by their original promotions," FDA Commissioner Dr. Mark B. McClellan said Aug. 8 in remarks at a National Press Club luncheon in Washington, D.C.
Dr. McClellan also said the FDA is examining its requirements for how risks and benefits of prescription drugs are communicated, and is expected to issue new guidelines on direct-to-consumer drug advertising in the fall.
The FDA asked Bristol-Myers Squibb to respond by Aug. 21 with a plan of action on two points: the "immediate cessation of the dissemination" of the ads and promotional materials; and "prompt dissemination of accurate and complete information to the audiences that received the misleading messages."
A Bristol-Myers Squibb spokeswoman said the company received the letter and will work with the FDA to resolve the situation.
Bristol-Myers Squibb last year spent $31.5 million advertising Pravachol, which is handled by Havas' Euro RSCG Becker Life, New York. The FDA's warning letter was sent directly to Peter R. Dolan, chairman-CEO of Bristol-Myers Squibb.
It is only the second time the FDA has asked a company to correct information following a misleading DTC ad. The first was in July 2001, when it sent a warning letter to Kos Pharmaceuticals regarding an ad that appeared in Time for cholesterol drug Niaspan.
Pravachol is a far bigger target. It is Bristol-Myers Squibb's best selling drug, with $1.3 billion in sales through the first six months of this year, although it trails market leader Pfizer's Lipitor, which had $7.9 billion in sales in 2002. Pravachol's patent expires in 2005 and a new cholesterol drug, AstraZeneca's Crestor, is readying a $40 million to $60 million marketing blitz (AA, July 21).
The Pravachol ads appeared in such magazines as Time, Good Housekeeping, Prevention and Reader's Digest; newspapers including the New York Times and Washington Post; and in marketing materials directed at both consumers and health-care professionals.
"This blows away the critics charging the FDA as being soft on the industry," said John Kamp, a Washington attorney who specializes in advertising. "This is a clear sign to the industry that if it isn't on the label, don't even think about putting it in your marketing materials."
The FDA charges that "promotional materials are false or misleading in that they claim that Pravachol has been approved by the FDA for conditions and patients for which it has not been approved."
Pravachol ads claims the drug is the only cholesterol-lowering medication proven to prevent first and second heart attacks and strokes in people with high cholesterol or heart disease, an assertion the FDA called "false."
In his National Press Club remarks, Dr. McClellan said Bristol-Myers Squibb made "claims that the drug was useful in a broader range of cardiovascular diseases than we have evidence showing is the case, that it is in fact safe and effective, and for implying that the drug is the only product useful for some conditions."
Pravachol's stroke-prevention approval from the FDA is for those patients already diagnosed with coronary heart disease. Though physicians have the ability to prescribe drugs for ailments other than what the medication might be intended for, pharmaceutical companies cannot market the drug in that manner unless approved by the FDA.
contributing: ira teinowitz