The Evolving “Game Face” FDA wears — Now Very Much in Evidence, at HQ in Raritan, NJ. . . .

After receiving an “Approvable Letter” from FDA in March 2008, Johnson & Johnson has encountered a rather significant set-back, on one candidate: JNJ will need to provide additional proof that it is appropriately monitoring the clinical investigators — for a host of potential maladies and mischief. I strongly suspect recent headlines about hidden conflicts in research animate this letter — though neither JNJ, nor FDA (per the usual practice of each) made the entire letter available to the public. [At right is JNJ's latest letter on DTC Ads.]

Here is the most-salient portion of the JNJ release, just this morning:

FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections

RARITAN, N.J., Nov 26, 2008 —

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring. . . .

The NDA for ceftobiprole was submitted to the FDA in May 2007, and, in March 2008, J&JPRD received an Approvable Letter regarding the ceftobiprole filing. J&JPRD responded to the FDA’s Approvable Letter in August 2008.

Ceftobiprole was approved earlier this year in Canada, and most recently it was approved in Switzerland. Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of ceftobiprole in the European Union for the treatment of complicated skin and soft tissue infections. . . .

More ominously, for its part, JNJ co-development partner Basilea says the FDA is unable to review the clinical data until “issues of data integrity have been resolved. . . .” That’s. Gonna’. Leave. A. Mark.

Ouch. Are you getting this, Fred?