In Public Citizen v. U.S. Department of Health & Human Services, No. 11-1681 (D.D.C. Sept. 5, 2014), a public interest group challenged the decision of HHS to withhold from a FOIA production various compliance materials submitted by Pfizer Inc. and Purdue Pharma L.P., which intervened and submitted affidavits in support of HHS’ position.  Plaintiff had requested all annual reports submitted by the companies to HHS pursuant to Corporate Integrity Agreements that resolved government allegations of off-label promotion of pharmaceutical products.  HHS withheld several categories of materials pursuant to Exemption 4, which covers “trade secrets and commercial or financial information obtained from a person and privileged or confidential.”  The withheld materials consisted of reportable events summaries, disclosure log summaries, information regarding actions taken in response to screening and removal obligations for ineligible persons, and documents reflecting the content of detailing sessions between sales reps and health care providers.  The court had little trouble finding that the materials were “commercial,” in that materials described basic business operations and thus served “a commercial function” or were “of a commercial nature.”  Plaintiff argued that the materials could not satisfy the “confidential” prong of Exemption 4 because some of the materials may pertain to illegal activity.  The court found that even if the activities described in the materials might be deemed illegal, the activities retained their commercial and confidential nature.  The court accepted the companies’ arguments that they had invested considerable resources in developing business practices that allowed them to stay within the bounds of the law in a complex regulatory environment where it is not always easy to determine whether a given practice is legal or illegal.  Public disclosure of this information, the court agreed, would provide a free roadmap to competitors who would not have to invest the same resources.  The court also noted that the companies maintain tight internal controls on the materials.  Accordingly, the court denied plaintiff’s motion for  summary judgment and granted summary judgment to HHS.