The worst fears of the drug industry—that state attorneys general (AGs) will add their muscle to the FDA's in marketing enforcement—may be seen in Merck's recent $58 million settlement of state consumer fraud claims arising from the marketing of since-withdrawn Vioxx.
The fact that it was a consortium of states that investigated and prosecuted this case, rather than the US Justice Department, may be attributed to the success of the White House in emasculating federal agencies.
In the Merck case, the state AGs won secondary commitments normally the exclusive province of the FDA:
- Refrain from using scientific data deceptively when marketing to doctors.
- Delay any DTC TV advertising for a pain medication if recommended by FDA.
- Submit all TV advertising campaigns to FDA for clearance before broadcasting
According to an analysis in May from the Washington law firm of McDermott, Will & Emery, in this settlement the AGs have “firmly positioned themselves as potent enforcers in their own right who have the will and the means both to extract significant financial penalties, and perhaps even more importantly, to impose significant going-forward constraints on the pharmaceutical and device industries.”
This outcome is precisely the opposite of what drug industry contributors aimed to get when they persuaded the Bush administration to push federal pre-emption of state tort laws. Their effort focused too much on labeling requirements and too little on fraud enforcement.
Now with the states emboldened and the prospect of a Democratic sweep in Washington in November, double trouble looms, especially if resources are found to beef-up FDA enforcement to complement the state efforts.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)