Restrictions on Promotion of Medications for ‘Off-Label’ Uses Raise Concerns, Opinion Piece States

"Efforts to confine patients and doctors to FDA-approved uses" of medications through 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 medical specialty societies and government researchers" -- raise the question: "Just who is in the best position to make these hard choices?" Scott Gottlieb, a physician and a resident fellow at the American Enterprise Institute for Public Policy Research, writes in a Wall Street Journal opinion piece.

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

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

According to Gottlieb, although such prosecutions "might be ... tolerable in a world where the FDA rapidly adjudicates ... what belongs in and out of drug labels," the agency "reserves 10 months to consider supplemental uses 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 staff manual for his attorneys a requirement that they merely check with a public health authority" such as NIH to "see if a certain 'off-label' use falls within the scope of appropriate medical care before waging a legal war" (Gottlieb, Wall Street Journal, 12/17).