Off-Label Promotion Analyzed, Fixes Involve Docs

From the April 6 2011 MedPage Today article

By Cole Petrochko, Staff Writer, MedPage Today

Healthcare professionals are the best defense against illegal off-label*** marketing of drugs, researchers found. “Our findings suggest that no regulatory strategy will be complete and effective without physicians themselves serving as a bulwark against off-label promotion,” Aaron S. Kesselheim, MD, MPH, of Harvard, and colleagues wrote in the April issue of PLoS Medicine. Despite regulations against off-label marketing, the practice appears to have fluorished in the last several years, the researchers noted. To get a better understanding of the problem, they analyzed whistleblower-initiated legal complaints filed in off-label marketing cases over the last 15 years…. … Prescriber-related practice complaints included: Encouraging healthcare professionals to prescribe for off-label use through false or unbalanced study data (76% of all prescriber-related practice complaints) Distributing free samples as a convenient source of off-label promotion (20%) Providing “lavish gifts” or honoraria to healthcare professionals (85%) Creating CME activity with speakers known to promote off-label use or through shell corporations (54%) Payer-related practice complaints included: Discussions with prescribers to ensure insurance reimbursement for off-label prescriptions (78% of all payer-related practice complaints) Discussions with payers to ensure insurance reimbursement for off-label prescriptions (35%) Advice on ways to bypass an insurer’s restrictions on a drug’s prescription (53%) Falsification of billing codes (48%)   ***Off-label use: In the United States, the regulations of the Food and Drug Administration (FDA) permit physicians to prescribe approved medications for other than their intended indications. This practice is known as off-label use [MedicineNet.com definition]

 

Related Articles

• Top Three Off-Label Marketing Strategies and Tactics (goodpromotionalpractices.com)
• Off-label marketing of medicines in the US is rife but difficult to control (eurekalert.org)
• More on Off-Label Promotion and the False Claims Act (druganddevicelaw.blogspot.com)
• A Godzilla Of A New Third Party Payer Dismissal (druganddevicelaw.blogspot.com)
• Off-label marketing of medicines in the US is rife but difficult to control (physorg.com)