The FDA has been warning for months now that individual pharma executives could be prosecuted when their companies disobey the rules. Naturally, drugmakers and lawyers want more info on the agency's intentions. And it seemed as if they'd get that info once the agency released some promised criteria for determining which people to prosecute.
The FDA did issue criteria--they're just not very helpful criteria, as Forbes points out. They're so general, they could apply to practically any top manager at any drugmaker under investigation for off-label marketing infractions, Medicaid overbilling, or what have you. The agency guidance doesn't clarify the legal basis of using the "Park doctrine" to prosecute individual executives, either, the magazine notes.
Not to mention the fact that the FDA added some caveats in the fine print; as Pharmalot reports, the criteria aren't binding, and other factors besides those listed may come into play. FDA Law Blog complains that the "criteria aren't criteria at all," in that case. So how can a well-meaning pharma executive avoid prosecution? The Park decision says managers have a duty to root out any wrongdoing at their companies. Internal prosecutors, perhaps?
- read the Pharmalot post
- get more from Forbes
- check out the FDA Law Blog piece