Big Pharma - "new rules"

Representatives of health care marketing firms, patient advocacy groups and pharmaceutical companies this week are in Washington, D.C., to express support for loosening rules regarding drug companies' ability to market medications for off-label uses, the Wall Street Journal reports (Mundy, Wall Street Journal, 4/18).

According to the Journal, the drug industry has recently become concerned over a "potential regulatory backlash" stemming from recent issues with the marketing of Vioxx and Vytorin, growing criticism from the presidential candidates regarding drug pricing and ongoing investigations by three congressional committees into drug-industry marketing practices.

A coalition of 10 drug companies -- including Pfizer, Bayer, AstraZeneca and Johnson & Johnson, and several patient-advocacy organizations, including the National Alliance on Mental Illness and the National Organization for Rare Disorders -- on Friday plans to submit to FDA its arguments against stricter marketing limits on off-label uses for prescription drugs. FDA currently is seeking comments on its proposed off-label promotion guidelines. The coalition is in favor of allowing companies to distribute peer-reviewed articles that inform physicians and hospitals of off-label uses for prescription drugs currently on the market.

The Journal reports that "worries about new rules" and the "chilly climate" in Washington, D.C., regarding prescription drug companies was apparent at a conference on Thursday sponsored by the drug-marketing publication DTC Perspectives. About 60% of respondents to a poll conducted during the conference said they were concerned about stricter federal rules on television advertising of drug products. According to the Journal, an "idea the drug marketers don't like" is a proposal that calls for a contact number to be included in all advertisements to allow consumers to make direct complaints to FDA.

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