Promo Violations Worse, Says US FDA

Drug industry promotions which violate US Food and Drug Administration regulations have increased over the past year, according to Lucy Rose, director of the FDA Division of Drug Marketing, Advertising and Communications.

She told an industry meeting recently that while she understood the pressures created by promotional budgets being reduced dramatically but sales goals remaining the same, companies should not set their representatives impossible targets. If goals are created that are higher than the entire universe of patients with the indication for which the product is approved, she said, the pressure is on the rep "to do what it takes to do the job." Moreover, she said, much of the training material which is sent to reps by company training departments includes details of "every off-label use that you could ever imagine," but then concludes: "Do not under penalty of death discuss this with any practitioner."

Ms Rose proposed that companies restructure their bonus schemes for reps based on finding out from physicians how successful the rep was in providing them with useful information about a particular product. They should be "creatively reimbursed," she suggested, based on the value they add in the practitioner's office.