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Advertising for new drugs is targeted by legislation

WASHINGTON - Pharmaceutical companies could be prohibited from advertising new drugs to consumers for their first two years on the market under a bill moving through Congress this week.

WASHINGTON - Pharmaceutical companies could be prohibited from advertising new drugs to consumers for their first two years on the market under a bill moving through Congress this week.

The goal, supporters say, is to ensure that medicines are safe in real-world use before the industry tries to drive up prescriptions and generate higher sales from patients' requesting new drugs from doctors.

If passed, the bill would be a blow to the pharmaceutical and advertising industries. Television and print advertising helped transform medications for heartburn and arthritis into blockbusters. According to one study, every $1 spent on pharmaceutical advertising often adds more than $2 in sales.

The Food and Drug Administration already screens a small portion of ads voluntarily submitted by drug companies. But consumer advocates favor much tougher regulation, arguing that the studies companies use to test the safety of new drugs are not always large enough to spot dangerous side effects.

"We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people," Consumer Reports analyst Bill Vaughan said. "The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."

The drug industry says pharmaceutical ads are an important tool for patients, giving them information about diseases and treatment options.

"Banning this information even for just a couple of years is not in the best interest of patients and physicians who every day make important health-care decisions," said Ken Johnson, vice president of the Pharmaceutical Research and Manufacturers of America.

Drugmakers spent nearly $5 billion on direct-to-consumer advertising last year, according to Nielsen Media Research Inc., and a 2004 study found that U.S. television viewers watched an average of 30 hours of drug ads per year.

The Senate committee that oversees the FDA meets today to put the finishing touches on a bill that would give the agency new powers, including a provision that would allow it to bar advertisements for two years after a drug was approved. The bill is being put together by Sens. Edward M. Kennedy (D., Mass.) and Michael Enzi (R., Wyo.).

Consumer advocates stress that the bill would merely give FDA the option of barring advertising, and that it probably would be used only for first-of-a-kind drugs.

But lawyers representing the drug industry oppose any tighter restrictions.

"In our system of jurisprudence, we have a very high threshold that protects the right to free speech, whether it's political or commercial," said Jim Davidson, attorney for the Advertising Coalition, which is funded by advertising firms and drug companies.

PhRMA, the trade group, has issued voluntary guidelines that call on members to submit all television advertisements to the FDA for review before they are broadcast.