Saturday, September 11, 2010

The FDA's "Park Doctrine" and BP

BP issued a 200-page investigation report this week into the Deepwater Horizon disaster that resulted in eleven deaths and spilled an estimated 205 million gallons of oil into the Gulf over 87 days. It concluded that the failures were multiple and complex.1

BP summarized, “Multiple companies, work teams and circumstances were involved over time." BP, Halliburton and Transocean have repeatedly pointed fingers at each other.

Representative Ed Markey, D-Massachusetts commented on the report, "Of their own eight key findings, they only explicitly take responsibility for half of one…BP is happy to slice up blame, as long as they get the smallest piece."2

The lack of a BP mea culpa caught my attention because pharma industry management cannot blame shift because of the "Park Doctrine."

Park, a CEO, was found guilty on all counts involving food held in a building contaminated by rodents. His personal defense claimed that he had an organizational structure responsible for such matters.

Chief Justice Burger delivered the opinion of the court, “…by reason of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct the violation complained of, and that he failed to do so…the imposition of this duty, and the scope of the duty, provide the measure of culpability…”3

One could summarize the US versus Park case as: “The buck stops here.”

For years, every FDA conference speaker has mentioned this landmark Supreme Court case at least once. This is because it’s an underlying tenant of FDA regulation enforcement—It is ultimately the responsibility of management to control its operation and to comply with the regulations, regardless whether parts of the operation have been delegated to others in the organization or third-party providers.

However, it looks like this is now more than an idle threat.

FDA Commissioner, Margaret Hamburg cited an internal committee recommendation to increase the appropriate use of misdemeanor prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable. Criteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions.4

One has to believe that the timing of dusting off the 1975 Park Doctrine at the FDA Commissioner’s Office is no coincidence. Things could get interesting.

1Deepwater Horizon Accident Investigation Report, September 8, 2010.
2BP Report Spreads Blame Across Gulf Spill Actors, CNN Wire Staff, September 8, 2010.
3U.S versus Park, 421 U.S. 658 (U.S. Sup. Ct., 1975)
4Letter from Margaret Hamburg, FDA commissioner, to The Honorable Chuck Grassley, ranking member of the Senate Finance Committee, Mar. 4, 2010.

The QA Pharm

No comments:

Post a Comment