Restrictions On Promotion Of Off-Labe Medication Uses Raise Concerns

Armen Hareyan's picture

Off-Labe Medication

"Effortsto confine patients and doctors to FDA-approved uses" of medicationsthrough restrictions on the promotion of treatments for "off-label"uses by pharmaceutical companies -- whether through "educational meetings,peer review journal articles, or treatment guidelines issued by medicalspecialty societies and government researchers" -- raise the question:"Just who is in the best position to make these hard choices?" ScottGottlieb, a physician and a resident fellow at the American Enterprise Institute for Public Policy Research, writes in a Wall StreetJournal opinion piece.

Gottlieb writes, "In many cases, doctors don't easily learn about thesenew drug uses, or get targeted education on prescribing, without the role ofthe drug firm that is the only deep-pocketed actor with an incentive to sharethis kind of information."


However, federal officials argue that, through promotion of medications for"off-label" uses, the "medical community is goaded by the drugcompanies into filing 'false claims' with the government, where hospitals andhealth plans charge Medicare and Medicaid for drugs used for unapprovedindications," Gottlieb writes. He adds that, although related"prosecutions were aimed at a handful of bad actors who encouragedprescriptions for purposes far outside popular medical practice," the"scope of those prosecutions expanded to encompass a much broader slice ofmedical activity."

According to Gottlieb, although such prosecutions "might be ... tolerablein a world where the FDA rapidly adjudicates ... what belongs in and out ofdrug labels," the agency "reserves 10 months to consider supplementaluses for marketed drugs, and the entire process usually is much longer."He adds, "For some patients, that interval can be fatal."

He writes that "Attorney General Michael Mukasey could add to the staffmanual for his attorneys a requirement that they merely check with a publichealth authority" such as NIH to "see if a certain'off-label' use falls within the scope of appropriate medical care beforewaging a legal war" (Gottlieb, Wall Street Journal, 12/17).

Reprintedwith permission from You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign upfor email delivery at . The Kaiser Daily Health PolicyReport is published for, a free service of The Henry J.Kaiser Family Foundation.


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