Off-Label Versus Unapproved: Parsing the Distinction

The Pharmalot blog has a post up today on the prosecution of pharma companies for encouraging off-label prescribing practices. The key bit:

Since 1997, when the Justice Department began receiving funding earmarked for fighting health care fraud, the AP notes the federal government has collected $11.87 billion in fines for various violations and returned the money to Medicare, Medicaid and other health care programs. The effort has largely been led by the US Attorney's office in Boston.

Whether law enforcement is having much effect is unclear. One could argue the recent spate of cases actually reflects older activity, and that companies have moved to take corrective steps by improving compliance procedures, implementing new policies and, in some cases, hiring an exec with a compliance background.

On the other hand, the recent episodes in which anonymous AstraZeneca and Pfizer employees have leaked material to various blogs, including this one, also suggests that off-label practices are alive and well, and industry compliance is either ineffective, incomplete or a sad example of 'saying one thing, but doing another.'

Last year I linked to coverage of a study that suggested that 20% of all prescriptions were for off-label purposes -- many of which were poorly supported by scientific research.  If those numbers are even somewhat accurate, it's a striking thing to consider.

Much of the criticism of the medical marijuana movement, for example, is premised on the idea that the scientific support for the use of marijuana is lacking. Propoponents of medical marijuana often reject that criticism, and the debate goes round and round. Whatever one's take on that issue, the prevalence of off-label prescribing suggests another line of argument: that in fact the scientific support for the use of "legitimate," FDA-approved drugs is actually surprisingly slim in about a fifth of all prescriptions. In other words, consumers may not be all that well justified in feeling safe using prescription meds, depending on the circumstances in a particular case.