FDA Readies Guidelines, Warns Bristol-Myers

WASHINGTON, D.C. The Food and Drug Administra-
tion will issue new guidelines for direct-to-consumer ads for prescription drugs, FDA Commissioner Mark McClellan said on Friday.

The guidelines, which will be announced in the fall, come as the FDA is stepping up its enforcement of rules against misleading drug ads.

“It is more important than ever for Americans to be protected from misleading claims not based on scientific fact,” McClellan said at a luncheon at the National Press Club.

The FDA is also increasing the number of warning letters it sends to drug companies that make false or unsubstantiated claims in ads. The government agency sent a warning letter Thursday to Bristol-Myers Squibb, saying that print ads for its anti-cholesterol drug Pravachol make false and misleading claims that the drug helps prevent stroke when there is no scientific evidence to support it.

Bristol-Myers Squibb has been ordered to pull its print ads, which have appeared in Time, Good Housekeeping, Smithsonian, U.S. News & World Report and other magazines. The drug company must also run counter ads saying that the drug does not prevent stroke.

Spending on prescription drug ads has risen steadily from $1.6 billion in 1999 to more than $2.5 billion last year, according to TNS Media Intelligence/CMR. Drug companies have spent more than $1.3 billion so far this year.