Critical condition

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DTC is on life support. Since Merck pulled Vioxx from the market in September, criticisms of the safety of DTC-advertised drugs have come from virtually all quarters.

The Food and Drug Administration, itself under fire by many who claim it is more poodle and less watchdog when it comes to DTC, has stepped up its vigilance in both rhetoric and record. In several speeches this year, acting FDA Commissioner Lester Crawford has repeatedly said DTC promotion needs to undergo wholesale change. To back it up, the FDA increased the number of warning letters sent to drugmakers from five in 2003 to 12 last year to six already this year.

Internally, pressure is building. Johnson & Johnson CEO William Weldon challenged his peers to change the way DTC ads are presented by including more risk information. But the challenge drew the ire of some of his colleagues, who called it a PR ploy (AA, March 28).

Congress has also taken an interest. Sen. Mike Enzi, R.-Wyoming, began hearings last month into drug safety and whether to draft legislation to change the FDA's authority. Investors have spoken, too. Merck shares in the last 52 weeks have gone from a high of $48.78 to $33.34 as of April 7. Pfizer: from $37.90 to $26.90. GlaxoSmithKline, Eli Lilly and AstraZeneca are down.

Quite a turn for a category that helped keep the entire ad industry afloat during the recession. Only three months ago, one health-care-agency president told Advertising Age, "There's no way [the ad industry, TV networks and magazines will] let a $4 billion-a-year business slip away."

Now, that decision might not be up to them.

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