What do consent decrees involving Schering-Plough, Abbott Laboratories and Genzyme have in common? In each case, the FDA also named the ceo and other high-ranking execs as defendants, not the just individual companies. However, the consent decree issued last week did not name Johnson & Johnson ceo Bill Weldon, or anyone else from the ‘c-suite’ at J&J or it McNeil Consumer Healthcare unit. Instead, the FDA named two McNeil Consumer Healthcare execs - the vp of quality and the vp of operations for OTC products.

There are several reasons for naming a ceo and these are determined, of course, by the variables in each situation - such as assessing responsibility, lines of reporting and the facilities involved, as well as other unique circumstances. And so the FDA does not always take the same approach. For instance, the consent decree signed in 2005 by GlaxoSmithKline for manufacturing violations appears not to have named any execs as defendants (see here).

Nonetheless, one could make a case that there is good reason to name the ceo. Arguably, the most noteworthy rationale is that such a move would send a message the c-suite is, ultimately, responsible not only for what took place but for remedying violations. There is value to the FDA, after all, in alerting other execs to the possibility they may also find themselves named for a series of over-the-top transgressions. But why was Weldon not named? We asked the FDA and received this response:

“Given the size of the firm, the corporate structure, where the violations occurred, and recent changes by McNeil and Johnson & Johnson related to management responsibilities for these facilities, the agency made a determination that the responsible officials named in the decree were the appropriate individuals that should be named to assure that the objectives of the agency were met,” an FDA spokeswoman wrote us. “We believe that this is consistent with how the agency has approached other cases once all the facts are considered.”

In other words, it appears the FDA spared Weldon and other c-suite players because of the decentralized organization encompassing the many J&J units; the violations occurred at plants in Puerto Rico and Fort Washington, Pennsylvania, and unspecified managerial changes. Whether this reasoning is consistent with past actions, however, is not entirely clear.

For instance, the other drugmakers that signed consent decrees are also large operations with various divisions, but at the end of the day, those units report to one executive - the ceo. And as in the case with J&J, the violations cited in those other episodes took place at disparate facilities. Ironically, the problems at the J&J plant in Fort Washington, Pa., is also the same location for the McNeil Consumer Healthcare offices, suggesting a larger degree of corporate oversight could have been expected than when reviewing other J&J locations.

As for managerial changes, Weldon and the J&J board decided last summer to name Ajit Shetty as a corporate vice president responsible for overseeing global manufacturing, quality and compliance. And last December, Alex Gorsky, worldwide chair of the medical device and diagnostics group (photo to the left), and Sheri McCoy, worldwide chair of the pharma group, were both promoted to to vice chairs of the executive committee, suggesting a succession horse race was under way. If the FDA is interested in assuring that “appropriate individuals” are named to achieve “agency objectives,” why not single out those who were recently given such responsibility? Then there is Peter Luther, who heads McNeil.

As for Weldon, some might argue he will soon retire. Officially, that is uncertain. When Gorsky and McCoy were promoted, the healthcare giant was adamant that Bill was going to stay on the job. Nonetheless, the FDA can accommodate any subsequent managerial changes. When Wyeth signed a consent decree in 2000, three execs were named, including Roy Sturgeon, who was senior vp of global quality assurance and quality control, and Bernard Poussot, who ran the pharma group and was later named ceo.

But by 2007, Sturgeon had retired from Wyeth and, therefore, was not responsble for overseeing the operations in question. As a result, he was no longer subject to the terms of the consent decree. Similarly, Poussot severed his ties to Wyeth two years ago after the drugmaker was acquired by Pfizer and a stipulation order was filed with the court indicating he was also no longer subject to the same consent decree (read here and here).

If there were other considerations involved in its reasoning for the J&J consent decree, the FDA is not saying. But under the circumstances, a few other episodes suggest the agency is being inconsistent and chose not to convey the sort of message that was sent with prior consent decrees. Weldon may have had the uncomfortable task of appearing before a congressional committee last year (see this), but he will not have to endure the rigors of being accountable for overseeing corrective actions that, ultimately, other pharma ceos and high-ranking execs had to bear. But what do you think?

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