As to the FDA investigation, Genentech noted that the agency had conducted a similar inquiry in 1992 and found no wrongdoing. "Genentech does not believe that it has violated any FDA laws," spokeswoman Laura Leber said.

News of the FDA and FTC inquiries come 10 days after a top Genentech executive and a major drug distribution company were indicted on federal criminal charges involving an alleged kickback scheme to a Minneapolis doctor to promote sales of Protropin. The indictment stemmed from an ongoing investigation by the inspector general's office of the Department of Health and Human Services.

Among the issues the FDA will look at is whether Genentech has used the foundation to promote Protropin for uses beyond those approved by the FDA, according to the FDA letter.