April 17th, 2007

Drug-Safety Bill Would Limit Direct-to-Consumer Advertising

Associated Press

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

The goal, supporters say, is to ensure medicines are safe before allowing industry to promote them to consumers in the hopes they will request prescriptions from doctors.

But a reduction in TV and print advertising, which helped transform medications for heartburn and arthritis into blockbusters, would be a serious financial blow to drug makers. According to one study, every $1 spent on pharmaceuticals advertising often adds more than $2 in sales.

While the Food and Drug Administration already screens a small portion of ads voluntarily submitted by drug companies, 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,” said Consumer Reports analyst Bill Vaughan. “The real testing of these drugs takes place after a pill hits the market and that’s why the advertising needs to be regulated.”

For its part, 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 for the Pharmaceutical Research and Manufacturers of America.

Drug makers spent nearly $5 billion on direct-to-consumer advertising last year, according to Nielsen Media Research, and a 2004 study found that American TV viewers watch an average of 30 hours of drug ads per year.

The freedom companies have enjoyed over the past decade to employ this marketing tool, however, is now in jeopardy.

The Senate committee that oversees the Food and Drug Administration meets Wednesday to put the finishing touches on a bill that would give the agency new powers, including a provision that would allow the agency to bar advertisements for two years after a drug is approved—a restriction the industry says is tantamount to a prohibition on free speech.

Sens. Ted Kennedy (D., Mass.) and Michael Enzi (R., Wyo.) began crafting the bill several years ago, following public outcry over FDA’s handling of the Merck pain reliever Vioxx, which was pulled from the market in 2004 after showing links to heart attack and stroke.

In an effort to show they can better regulate themselves, drug companies including Pfizer Inc. and Bristol-Myers Squibb Co. have voluntarily stopped advertising their prescription drugs for the first 6 and 12 months they are on the market.

And the trade group Pharmaceutical Research and Manufacturers of America recently issued voluntary guidelines for members to follow when promoting drugs to patients. The guidelines recommend companies submit all television advertisements to FDA for review before they are broadcast. Under an agreement reached last year, companies are expected to start paying the agency more than $80,000 for each ad reviewed in 2008. The agency said it will use the money to hire 27 new employees.

Figures from FDA suggest companies are indeed changing how they promote their medicines. The agency has only cited four companies for consumer-directed ad violations since January 2006. FDA made 17 citations in 2005.

Still, lawyers working for the drug industry are attacking proposals that would mandate even 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. “What they’re saying with this ban is “we don’t know where the harm is, but we know there’s a statistical likelihood that some adverse event will occur, therefore you can’t promote your product.’”

Mr. Davidson has urged Senate staffers to eliminate the provision on advertising, arguing that the Supreme Court has already struck down similar attempts to regulate commercial speech.

Consumer advocates who support the measure stress that it would merely give FDA the option of barring advertising, and would probably only be used on first-of-a-kind drugs. But that hasn’t assuaged drug companies that increasingly invest in consumer-directed marketing.

Most of the blockbuster drugs of the last decade have been supported by heavy TV advertising, beginning with AstraZeneca’s heart-burn medication Prilosec in 1998 and continuing to the current campaign for Bristol Myers and Sanofi-Aventis’ blood thinner Plavix.

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