Nature Medicine | Spoonful of Medicine

The prosecution of pharma gets personal

Our September 2010 issue featured an Opinion piece written by Jeb White, a partner with the national whistleblower law firm of Nolan & Auerbach, P.A. in Philadelphia, Pennsylvania. The title was pretty self-explanatory: Masterminds behind pharmaceutical fraud deserve prison time.

It seems as though regulators are following this train of thought. The week Drug Topics has a piece about how the US Food and Drug Administration “has a new target in its continuing efforts to clean up pharmaceutical industry abuses: ”https://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=713115&sk=29aa4165af6185f84b80f4992efe0b55">individual corporate officials".

Recently, the agency targeted two VPs at McNeil Consumer Healthcare, a Fort Washington, Pennsylvania-based unit of Johnson & Johnson, following the massive recall of its over-the-counter pain reliever Tylenol. “[I]t appears the FDA spared [J&J CEO Bill Weldon] and other c-suite players because of the decentralized organization encompassing the many J&J units,” according to the Pharmalot blog.

That echoes a point made by Jeb White’s Opinion piece: “The complex organizational structure of most large corporations prevents government prosecutors from readily building a criminal case against a particular employee. Modern corporations are highly compartmentalized. For example, in the pharmaceutical or biotechnology industry, the research and development divisions operate largely separately from the marketing divisions that promote the resulting drugs.”

What do you think? Should the FDA be taking individuals to court or the companies they work for? Share your thoughts here in the comments section.

Comments

  1. Report this comment

    Alan said:

    Can we vote for both? It would depend on the particulars for each case, but I can imagine instances where both the individual and the company should be seen (and prosecuted) as culpable. Maybe the industry should be better regulated to prevent complex organizational structures from shielding top management.

  2. Report this comment

    Pat Walling said:

    I agree with Alan. It really has to depend on the case. I can imagine cascading failures of communication between several sections of a large corporation resulting in prosecutable errors, and I can also imagine devious machinations on the part of one or several individuals that cause harm to a company. And there are probably more legal issues of culpability I’m not even aware of, not being a lawyer myself.

    In unrelated news though, do you accept guest posts? Drop me a line, thanks.