FDA flubs off-label enforcement

When it comes to policing off-label marketing, the FDA is no SWAT team, a new report from the government's auditor shows. It's more like the Keystone Cops, ill-equipped to crack down even on blatant marketing abuses, the Associated Press reports. There's no staff exclusively assigned to monitor off-label marketing, and when the staff that monitors all prescription-drug advertising manages to catch a drugmaker promoting off-label uses, it takes an average of seven months for them to issue a warning--and an average of four more months for the company to fix the problem.

The agency tries to focus its attention on misrepresentations that could affect human health, the report found, but it lacks a system to track all the information it receives.

The General Accountability Office investigated off-label marketing enforcement at the request of Sen. Chuck Grassley, who, as you know, has been hounding drugmakers on various marketing-related issues all year. Whether the report will lead to any action--or just another set of hearings--remains to be seen.

- see the AP story [1]

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Rep decries off-label marketing "loophole" [4]