Health and Medical News and Resources

General interest items edited by Janice Flahiff

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]

 

April 11, 2011 - Posted by | Consumer Health, Public Health | , , ,

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