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District Leads Nation in Confronting Unsafe Marketing Practices
Washington, D.C. – Councilmember David Catania (At-Large) said that yesterday’s record-breaking $2.3 billion settlement between the United States Justice Department and Pfizer Inc. underscores the need for greater regulation of the methods by which prescription drugs are marketed. He also noted that the landmark settlement demonstrated the necessity and appropriateness of the District’s SafeRx Act of 2008, which is now law. Last year, Catania authored SafeRx to curb the use of many of the abusive marketing practices found to have been committed by Pfizer, including the use of trips, gifts, meals, and massages to influence doctors’ prescribing decisions.
SafeRx also targets the serious, and potentially dangerous, practice of marketing drugs for “off-label” uses, or those not approved by the Food and Drug Administration (FDA). This practice is known to be pervasive throughout the pharmaceutical industry. For instance, as part of yesterday’s settlement, Pfizer admitted to marketing the drug Bextra for uses including acute and surgical pain relief that were specifically rejected by the FDA over safety concerns. Catania said that during the Bush Administration, an under-resourced and disinterested FDA made the widespread use of off-label marketing possible.
“Our doctors are bombarded by pharmaceutical representatives urging them to prescribe the latest and most expensive medications,” said Catania. “Until recently, no one, including the FDA, was monitoring these sales pitches to ensure that they were accurate and safe, not to mention aimed at promoting the most effective and least costly drugs. In the rare instance that the FDA uncovered an abuse, the most severe penalty it imposed was a letter saying ‘please stop.’ The drug companies simply thumbed their nose at these letters.”
In the absence of a consequential federal response to the problem, Catania’s SafeRx legislation established the first licensure requirements for pharmaceutical detailers (i.e., salesman) in the country. In doing so, the District became the first jurisdiction to create a professional code of conduct for detailers. The law also created a system of fines and penalties, including the revocation of one’s license, for those that violate these standards. Finally, SafeRx required detailers to have an appropriate educational background. Since its inception, the District has issued 1,867 licenses to pharmaceutical detailers.
In addition to regulating detailers, SafeRx instituted an academic detailing program to educate physicians on the latest developments in pharmaceutical research. As part of the program, academic detailers visit doctors and use scientifically tested information to promote the most effective and lowest cost prescription drugs for a given condition. The first phase of the District’s academic detailing program focused on the management of Type-II Diabetes. In only a short time, District representatives have visited 163 different physicians. The second phase is expected to be announced this month.
“Pharmaceutical detailers have come to play a huge role in our healthcare system. It is no longer acceptable to allow them to operate without appropriate standards and real consequences for violating those standards,” said Catania. “The costs to consumers and the risks to patient safety from the abuses committed by Pfizer and others are enormous. I am very pleased that the District is the first place in the country to confront this issue in a meaningful way.”
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