The Boston Globe, July 22, 2005

Draft leaves out new-products ban

WASHINGTON -- Lobbyists for the drug industry yesterday released the outline of a voluntary code of conduct detailing how drug companies should advertise prescription products to consumers, but the guidelines fall short of what some politicians sought.

Earlier this month, Senate Majority Leader Bill Frist, Republican of Tennessee, called for a voluntary two-year ban on advertising for new drugs, taking a more conservative stand than a proposed Senate bill that ties such advertising restrictions to products suspected to be unsafe. Already, one drug company has pledged to not launch ads for at least the first year a new drug is sold.

The code of conduct tentatively approved yesterday by the board of directors of the Pharmaceutical Research and Manufacturers of America does not include an advertising moratorium, and Ken Johnson, the lobbying group's senior vice president, could not say whether one will be incorporated into the final document.

''We've got it pretty well nailed down, but we still have to tweak some of the language. But I'm just not prepared at this time to get into the specifics of the code until it's formally announced," Johnson said. ''In the end, some of our companies may decide to go above and beyond the new principles. It's their choice."

In a statement, Frist said, ''I'm pleased that PhRMA is acting so quickly following my call for greater restrictions on out-of-control direct-to-consumer advertising. I look forward to reviewing the industry's complete and final recommendations and examining areas where improvements may be needed."

More than half of 2,207 Americans polled this month by The Wall Street Journal and Harris Interactive said advertising should be banned when drugs are first sold so that doctors can learn about the products without being pressured by patients demanding prescriptions for drugs they have seen advertised. Last year, about $4 billion was spent on advertising.

For now, the guidelines recommend that the group's member companies talk to doctors before advertising campaigns are launched. Addressing concerns raised by parents about erectile dysfunction advertisements airing on television during prime time, the group said drug companies should air ads that are appropriate for the age of likely viewers.

In addition, it said companies should educate consumers about health conditions and diseases, a type of advertising not typically regulated by the FDA. Advertising should also inform people who do not have insurance about how they can receive free or discounted drugs, the group said.

''Voluntary guidelines are only as potent as the people that adopt them," said Peter Pitts, a former FDA associate commissioner. When the agency in 1997 relaxed its rules, drug makers unleashed a torrent of television advertising.

Pfizer Inc.'s chief executive, Hank McKinnell, said he was unsuccessful in getting industry support for advertising restrictions when he was board chairman of the manufacturers group. Peter R. Dolan, expected to become the lobbying group's next chairman, currently leads Bristol-Myers Squibb. Last month, that company pledged to spend at least one year educating doctors about new drugs before advertising those products to consumers.

''They get it," Pitts said of the drug industry executives' push to improve direct-to-consumer advertising. It becomes a problem ''when you talk to people who are brand managers whose bonuses are pegged to achieving sales goals in one or two quarters," he said.

Diedtra Henderson can be reached at dhenderson@globe.com.