Opinion ID: 799929
Heading Depth: 3
Heading Rank: 3

Heading: Criminal Case Against Schering

Text: In June 2001, the FDA's Division of Drug Marketing, Advertising, and Communications sent Schering Sales a letter notifying it that the FDA had identified various promotional activities that [were] in violation of the [FDCA] and its implementing regulations. (Information at 12-16, United States v. Schering Sales Corp., No. 06-CR-10250 (D.Mass. Aug. 29, 2006)). The letter cited a May 2001 American Society of Clinical Oncology Annual Meeting in San Francisco at which the FDA witnessed Schering sales representatives give purportedly false or misleading efficacy information about Temodar to visitors at the commercial exhibit hall booth, and promote[ ] Temodar for the unapproved use in first line therapy of anaplastic astrocytoma. ( Id. at 12-13). The FDA's letter requested that Schering immediately cease making such violative statements and any other promotional activities or materials for Temodar that make the same or similar claims or presentations. ( Id. at 13). In August 2006, the United States Attorney for the District of Massachusetts charged Schering Sales with conspiracy to make false statements to the federal government, in violation of 18 U.S.C. § 371. ( Id. at 12-16). The Government's one-count Information alleged that Schering Sales and its co-conspirators knowingly and willfully made material false statements to the FDA. ( Id. at 8). It stated that Schering Sales' response to the FDA June 2001 letter specifically asserted that Schering's home office had aggressively pursued sales of Intron A and Temodar for unapproved uses through numerous methods, including training the sales force to seek off-label sales, requiring the sales force to create business plans that emphasized detailed promotional goals to obtain off-label sales, and compensating the sales force partly on their success in achieving off-label sales. ( Id. ) Schering Sales pleaded guilty to the one-count Information pursuant to a written Settlement Agreement. ( See Amended Judgment, United States v. Schering Sales Corp., 06-CR-10250 (D.Mass. Feb 7, 2007)). Under the Settlement Agreement, Schering Sales agreed to pay fine of $180 million. ( Id. ) It also agreed to pay $255 million to resolve civil claims that it defrauded U.S. Government health benefit programs, including Medicare, Medicaid, and the Veteran's Administration. ( Id. )