FDA Warns Merck Over Marketing Efforts

WASHINGTON–Federal regulators warned Merck&Co. for improper marketing of its blockbuster arthritis drug Vioxx, saying the company had misrepresented the drug’s safety profile and minimized its potential risks, Tuesday’s Wall Street Journal reported.

The Food and Drug Administration, in a Sept. 17 warning letter, chided Merck (MRK) for its efforts to promote Vioxx to health professionals, which included audio conferences, a news release and statements made at medical conferences. FDA officials said the actions were “particularly troublesome” because the agency had previously objected to promotional material that it said also misrepresented Vioxx’s safety profile.

While the FDA sends out dozens of routine citations annually, it issues only a handful of these more-serious warning letters each year. The agency cited Merck for glossing over what might be a higher rate of heart problems among patients taking Vioxx when compared with those on another medication, as well as a risk of bleeding for patients taking the drug in addition to another widely prescribed medicine.

Among other things, the agency told Merck to develop a plan to immediately cease the activities it cited, as well as to send what’s typically known as a “dear doctor” letter to all health-care providers who were or may have been exposed to the misleading promotions. The letter has to be reviewed by the FDA and is intended to correct the false or misleading information Merck distributed.

Merck’s Vioxx is waging a bitter battle with Celebrex, a similar arthritis drug co-marketed by Pfizer Inc., of New York, and Pharmacia Corp., of Peapack, N.J. Both had amazingly successful drug launches in 1999 and quickly became staples in many medicine cabinets. But in the midst of trying to attract patients and their prescribing doctors, the marketers of both drugs have been cited by FDA officials for going too far. Vioxx is expected to bring Merck $3 billion in sales this year and is crucial to the company as it weathers a period of patent expirations — and steep sales declines — of some major drugs.

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