A reported FDA plan, secretly developed to enforce the rarely used 36-year-old “strict liability” Park Doctrine against Forest Laboratories CEO Howard Solomon, reflects a poorly performed balancing of interests—given that the agency always forgives itself for the transgressions of its own subordinates.
Before media publicity forced the government to say Solomon had not (yet?) been personally excluded from participating in federal programs, he was reported to be facing separate sanctions for off-label marketing infractions that his company has already been penalized for—to the tune of $313 million.
As I understand it, the Park Doctrine under which this punishment would have been added, places strict, personal criminal liability on a company's highest officer based on the second part of “known or should have known” with respect to misdeeds by subordinates.
My observations over the years have been that FDA never enforces this “or should have known” element. Since the “or should have known” standard is never applied, is it any wonder that regulatory infractions by subordinate employees continue to go unpunished, or that the comparatively rare consequent acts of FDA enforcement against their employer corporation are then routinely written off as the “costs of doing business”?
This habitual winking at the Park Doctrine has allowed, especially in the off-label promotional claims area, the American consumer to be led astray.
FDA should either get serious by sending its Park Doctrine messages to industry in a consistent manner, every time, or accept that this is an enforcement weapon that it is afraid to use.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)