Drug, ad firms gird as House takes up FDA revamp

WASHINGTON -- Pharmaceutical and advertising industry lobbyists who thwarted attempts in the Senate to rein in drug advertising now turn their attention to the House of Representatives, which is scheduled to take up legislation to overhaul the Food and Drug Administration today.

Advertising for pharmaceuticals was a $1.3 billion business in the first three months of this year, on pace to rival the $5.6 billion spent in 2006, according to Nielsen Monitor-Plus . The industry says that such ads can alert patients to undiagnosed medical conditions. But critics say the ads overstate the benefits of prescription drugs and boost spending on expensive new medications.

Exhibit A in the critics' case is Vioxx , a painkiller manufactured by Merck & Co. that was propelled to blockbuster status by ads featuring Olympic skater Dorothy Hamill , even as concerns about the drug's effect on cardiovascular health grew. Vioxx was blamed for tens of thousands of deaths before its manufacturer pulled it from the market.

Early versions of FDA overhaul legislation discussed in the Senate would have imposed a ban on ads for drugs in the first two years they're sold to consumers. That provision was deleted from the bill passed by the Senate on May 9, although the bill did give the FDA the ability to levy hefty fines for ads that are false or misleading . Senators also approved additional money, taken from fees paid by the drug industry, to increase the number of FDA employees who review such drug ads before they air.

In the House, the drug and advertising interests are trying to fend off a push to set a three-year cooling off period before new drugs with the potential to cause serious harm could be promoted through print, radio, or TV advertising. Clinical trials that the FDA uses to decide whether a drug is safe and effective enough for sale involve just a few thousand patients who usually are younger and healthier. The House bill gives the FDA up to three years to collect details on how a new drug affects a larger pool of users before the product can be advertised.

Even as the House begins deliberations, hype surrounding a new drug is helping to crystallize the debate.

Gardasil, the new vaccine to prevent cervical cancer, has fervent fans, vocal critics, and, thanks to a spirited ad campaign, a long line of girls in New Hampshire who want it, but can't get it. State officials offered the $300 , three-dose vaccine shots for free , leveraging mostly federal and insurance company funds to pay for the pricey shots. Merck's promotion of Gardasil, however, boosted demand beyond expectations.

The question before the House, in essence, is should new drugs be advertised like Gardasil?

"This is a whole new territory for everyone," said Jose Montero , state epidemiologist in New Hampshire.

Billy Tauzin , chief executive of the Pharmaceutical Research and Manufacturers of America , says such ads provide a valuable service in informing the public about new drugs that could dramatically improve their lives. As a child, Tauzin suffered from osteomyelitis , an acute bone infection caused by bacteria. He was one week from amputation of his right foot .

"My mother read about penicillin in the rural countryside of Louisiana and brought that information to our doctor, who didn't know that penicillin was being used to treat osteomyelitis. [He] got her information. Put me on a course of penicillin. I have my foot today," Tauzin said.

A "rigid" moratorium doesn't leave room for drugs -- like Gardasil -- that patients should know about and, ultimately, such restrictions hurt patients, he said.

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