Too much off-label regulation?

The Internet is buzzing about a Wall Street Journal op-ed piece in which ex-FDA deputy commissioner Scott Gottlieb (photo [1]) championed the sort of off-label promotions that make regulators crazy. Gottlieb cited a couple of cases in which drug makers have paid multi-million dollar fines for pushing meds in non-FDA-approved directions. The whole off-label promotion ban is wrong, Gottlieb says, and it hurts patients who might benefit from off-label uses if their docs only knew.

Yet, as the WSJ Health Blog points out, off-label marketing isn't allowed for a reason. Some of it amounts to cherry-picking studies that support new uses for a drug. Marketers often ignore the trials that conclude otherwise. But has the FDA gone too far in policing the practice? Debate is likely to continue.

- read the Health Blog item [2]
- here's the Pharmalot report [3]
- read Gottlieb's original op-ed [4]

Related Articles:
Rep decries off-label marketing "loophole." Report [5]
New warning for off-label Fentora. Report [6]