Glaxo settled with the USG this week (WSJ), agreeing to pay $3 billion on charges of off-label promotion and several other issues. (For general background on these suits, see Kesselheim, Mello & Studdert in PLoS Medicine 2011)
- Compared to Glaxo US revenues during the settlement period, this is a mere “speed bump” for them, akin to parking tickets for UPS or any other cost of doing business. Total off-label promotion settlements for all companies has been about $12 billion the last 15 years, averaging less than a billion per year. Annual US sales, about $350 billion.
- This will be one of the last US drug company settlements for off-label marketing. As previously discussed here at TIE, after Sorrell v. IMS Health, the companies will defend off-label marketing on First Amendment grounds. In a separate article, the WSJ discusses this today.