Healthy Skepticism Library item: 19071

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
The FDA Criteria For Going After Pharma Executives
Pharmalot 2011 Feb 8
http://www.pharmalot.com/2011/02/the-fda-criteria-for-going-after-pharma-executives/

Full text:

Nearly a year ago, the FDA wrote US Senator Chuck Grassley that criteria had been developed to determine which cases should be selected for prosecuting individual executives (read the letter). The move came after growing criticism that drugmakers paid huge fines to settle allegations of fraud, but higher ups were never held responsible and the payouts were seen as a cost of doing business.
Since then, FDA deputy chief for litigation Eric Blumberg gave a speech reiterating agency interest in targeting pharma execs (back story). These moves also come as the Health and Human Services Office of Inspector General pushes for measures to make it possible to ban pharma execs from doing business with federal health programs, if their companies have been convicted of fraud.
The FDA plan, though, has been to use the Park doctrine, which says a corporate official can be convicted of a misdemeanor based solely on his or her position of responsibility and ability to prevent underlying violations of the Food, Drug & Cosmetic Act. The doctrine also stipulates there is no requirement that an exec acted personally in any wrongdoing, or had knowledge of the wrongdoing.
But the FDA never released the criteria – until late last month. So what are the factors to consider? Whether the violation involves actual or potential harm to the public; whether the violation is obvious; whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings; whether the violation is widespread and/or serious; the quality of legal and factual support for the proposed prosecution; and whether the proposed prosecution is a prudent use of FDA resources.
To what extent these will be deemed helpful to those trying to avoid trouble is unclear. As the FDA explains, the criteria “do not create or confer any rights or benefits for or on any person, and do not operate to bind FDA. Further, the absence of some factors does not mean that a referral is inappropriate where other factors are evidence” (here is the Regulatory Procedures Manual).
In other words, there is wiggle room, especially since these are not binding. Or as the FDA Law blog carps, the criteria are not really criteria at all. In fact, these are not so different from the sort of litmus test used to assess most any violation. As a result, pharma execs and their lawyers may be gnashing their teeth. Perhaps the agency will one day fine tune its criteria, or not. Meanwhile, of course, it is up to prosecutors to prosecute. But maybe the open-ended nature of this list is deliberate – leave them guessing, as they say.