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FDA studies coupon programs offered by major drug companies

WASHINGTON—In the battle for new patients and greater market share, U.S. drug makers are putting their faith in a time-tested, albeit pedestrian, marketing strategy.

Coupons, money-back guarantees, rebates and other supermarket-friendly promotions offering "10 percent off," "free trial offers" or "buy six prescriptions, get one free" are now standard marketing tools for many top-selling prescription drugs.

The heartburn drug Prevacid offers patients $25 rebates on their next prescriptions. Lipitor and Crestor, two leading cholesterol-lowering drugs, offer free 14- and 15-day trial periods. And Lotrel, a blood pressure medication, will reimburse consumers' out-of-pocket drug costs for up to four months if the drug doesn't work effectively.

Drug industry officials said the offers allow consumers to test and compare medications without bearing the full financial risk. By providing relief from high drug prices, they also can improve interaction between doctors and patients.

"In some cases it becomes a tool for them to initiate a potentially difficult conversation, (about topics) such as depression or erectile dysfunction. And that's important," said Paula Garrett, a consumer marketing specialist at Eli Lilly.

But as the promotions become more ubiquitous, turning up in magazines, on Web sites and in doctors' offices, they're also creating unease among some in the medical community, including in the U.S. Food and Drug Administration.

A group of 24 patient advocacy groups led by the Boston-based Prescription Access Litigation Project has asked the FDA to ban the promotions. The groups claim that the offers improperly influence a doctor's prescribing decisions and steer patients toward expensive brand-name medications and away from cheaper generic drugs.

"I think those are legitimate concerns," said Dr. Richard Kravitz, the director of the Center for Health Services Research at the University of California, Davis, Medical Center in Sacramento.

Promotions aimed at children have drawn particular concern. Differin, an acne drug, offers $10 prescription rebates and free music downloads to patients 13 and older.

Diane Zuckerman, president of the National Research Center for Women & Families, said in a letter to the FDA that the agency should immediately ban such promotions aimed at youth under age 18.

Even the FDA is concerned. In a recent agency filing, regulators said that "prescription drugs promoted with coupons or free trial offers may be seen as more widely indicated, more appropriate and/or less risky than they really are."

The problem is especially great when the offers are included in so-called "reminder ads," which provide no information about the advertised drug's potential risks.

Charles Brown, a vice president at NCH Marketing, a coupon processor in Deerfield, Ill., said discount promotions are popular because researchers have found that they spur more sales than by simply lowering a product's price.

"To bring an increase in sales, it really requires some type of promotion, merchandising or some event to bring that awareness and excitement about savings. That's where coupons come in," Brown said.

It's partly psychological, said Kent Monroe, a marketing professor emeritus at the University of Illinois who's studied consumers' responses to coupons.

"When people perceive that an item is on sale or on deal, that does enhance their perception of the value of the product itself," Monroe said.

That's OK for discretionary items such as food, clothing and household goods. But "for more complex products like prescription drugs, where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send different signals," the FDA wrote recently. "These signals may foster consumer misperceptions about the advertised prescription drug product."

To sort it all out, the FDA will conduct a study on whether discounted promotions in prescription drug print ads affect how consumers view the risks and benefits of an advertised drug. "To justify future regulatory changes, we need to have better empirical data," the FDA wrote.

Drug makers say no changes are necessary.

Scott Lassman, the assistant general counsel for the Pharmaceutical Research and Manufacturers of America, said in a recent FDA filing that the promotions are regulated by various state and federal laws. "Coupons, free trials, money-back guarantees and other promotional tools have many benefits and should remain available as part of responsible direct-to-consumer promotional practices," he added.

The McKesson Corp., a major drug distributor, administers free trial offers for most U.S drug companies through its TrialScript program. Since 1994, McKesson has helped more than 10 million patients redeem 14.2 million coupons. The program requires a signed patient voucher and a doctor's approval to get the free medication from a pharmacy.

Kerr Holbrook, vice president for marketing at McKesson's specialty pharmaceuticals division, said the trial offers are a safer alternative to doctor-provided samples, which are often given with little or no recordkeeping and no regard to how the medication will interact with other drugs a patient is taking.

He said the free trial offers allow patients to get the benefits of drug therapy, which in turn will encourage them to continue treatment.

"Once it starts working and they start feeling a little better, there's a lot more incentive to continue taking the medication," he said.

In a letter to the FDA, Ann Richardson Berkey, McKesson's vice president for public affairs, wrote that "by enabling a patient to use a drug on a trial basis prior to making an investment in a new drug therapy, coupons can be a valuable asset in the face of today's increasing drug costs."

Kravitz, of the University of California, agreed but added, "The downside is that there's no ongoing financial support, and in the aggregate, it will tend to shift people away from the most cost-effective choice of prescription medication."

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(c) 2006, Knight Ridder/Tribune Information Services.

ILLUSTRATIONS (from KRT Illustration Bank, 202-383-6064): drugcoupons

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