Abbott Hesitates To Promote Niaspan Study Due To FDA Rules
Not so fast.
The Abbott Park, Ill., company isn't running ads touting the results and has forbidden its sales representatives from promoting them to doctors because the new data aren't yet incorporated into the Niaspan prescribing label. Drug makers are generally barred from promoting uses of products that aren't consistent with prescribing labels approved by the U.S. Food and Drug Administration.
The Abbott-funded "Arbiter 6" study, presented at a major cardiology meeting Monday, found Niaspan was superior to Merck & Co.'s (MRK) Zetia at reversing the narrowing of the arteries. Patients in the study also were taking cholesterol drugs known as statins.
The FDA-approved Niaspan label says it can be taken with an older class of non-statin cholesterol drugs to slow progression or promote regression of thickening of the artery. The label mentions taking Niaspan in combination with statins, but only as a way to improve cholesterol levels, not to mitigate artery thickening.
If Abbott wants to promote the use of Niaspan in combination with statins specifically to unclog arteries, the company would have to submit the Arbiter 6 data to the FDA to try to get it incorporated into the label.
"We haven't really evaluated what we're going do with the data from a regulatory standpoint, but we're reviewing it and figuring out what our next step might be," said Abbott spokeswoman Elizabeth Hoff.
Meantime, "our sales reps were made aware very specifically that this is data they cannot promote," she said.
Abbott's Niaspan sales for the nine months ended Sept. 30 rose 6.4% to $601 million, and analysts expect sales to continue rising due to the Arbiter 6 results, despite Abbott's inability to immediately promote them. Doctors have plenty of ways to learn the results of Arbiter 6 through media coverage or by having attended the cardiology conference.
But Abbott's promotional silence underscores the heightened government scrutiny of pharmaceutical marketing. Many drug makers have gotten into costly legal trouble for off-label promotion of drugs and are now eager to be seen as doing the right thing.
"The climate has really shifted," said Michael Luby, co-founder of TargetRx, a Horsham, Pa., provider of marketing research to the pharmaceutical industry.
One potentially safe marketing route: Luby said federal rules would probably permit Abbott to distribute to doctors reprints of the Arbiter 6 results as published in the New England Journal of Medicine, but in a non-promotional way. Some companies try to be conservative and only distribute reprints when doctors request them, Luby said.
Meanwhile, Pfizer Inc. (PFE) has stepped into the promotional void. The New York drug company ran full-page newspaper advertisements earlier this week touting its Lipitor cholesterol drug, the No. 1 prescription drug in the world by sales. "Not every cholesterol-lowering medicine can pass this checkup," one ad said, noting Lipitor is FDA-approved to reduce the risk of heart attack and stroke, among other benefits.
Pfizer spokeswoman Sally Beatty didn't address whether the ads were timed to coincide with the Arbiter 6 data, or which other drug or drugs the ads were referring to. Lipitor ads are meant to encourage patients with high cholesterol and other heart-disease risk factors to seek treatment, she said.
Merck of Whitehouse Station, N.J., has said it would communicate to influential doctors the company's confidence in the efficacy and safety of its cholesterol drugs, in the wake of the Arbiter study.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
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Publié le 19 novembre 2009 Copyright © 2009 Dowjones
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