The Office of Inspector General (OIG) recently released its Fiscal Year (FY) 2011 Work Plan. The OIG FY2011 Work Plan discusses the specific audits and evaluations OIG has underway or plans to initiate in the upcoming year ("programs") with respect to the operations of the Department of Health and Human Services (HHS). Below is a list of new FDA-related programs included in the OIG FY2011 Work Plan.

  • Complaint Investigation Process: The OIG will review the adequacy of FDA's complaint investigation process, upon which the agency relies in its efforts to protect the public against injury and illness from contaminated or harmful foods, feed, drugs, cosmetics, medical devices and biological products. The OIG will also review FDA's processes for categorizing and using complaints to identify potentially significant trends or patterns in reported illnesses or injuries.  
  • Safety and Effectiveness of Part D Drugs: The OIG will review whether the drugs used in the Part D program were previously found to be safe and effective by FDA in accordance with statute (21 U.S.C. § 355). To ensure that drugs are safe and effective, FDA requires that drugs used by the public be approved and registered. As part of a safety initiative, CMS instituted a policy effective January 1, 2010, to ensure that Part D beneficiaries receive only drugs that are properly registered with FDA. The OIG will determine whether Part D beneficiaries were dispensed drugs that FDA had deemed safe and effective.  
  • FDA's Oversight of Postmarketing Surveillance Studies of Medical Devices: Under section 522 of the FDCA, FDA may require manufacturers of medical devices to complete postmarketing surveillance for any moderate- to high-risk medical device (Class II or III) that, if it failed, has a reasonable likelihood of serious adverse health outcomes. The OIG will examine the extent to which FDA has required postmarketing studies of medical devices, the level of compliance among sponsors that have been required to perform such studies and FDA's oversight of sponsors' study commitments. The OIG will also identify trends and challenges associated with postmarketing surveillance studies.  
  • FDA Reportable Food Registry: The OIG will determine the extent to which food facilities comply with key requirements of the FDA's Reportable Food Registry to track foodborne illness. The OIG will also determine whether there are any known instances of reportable foods that facilities did not report to FDA as required.  
  • FDA's Oversight of INDs: The OIG will review FDA's process for evaluating INDs, including an assessment of FDA's timeliness and identification of challenges to the IND review process.  
  • Submission of Electronic Drug Labels: The OIG will review FDA's oversight of drug manufacturers' compliance with the requirement to electronically submit to FDA complete and accurate drug labels for currently marketed prescription drugs. The OIG will examine the accuracy and completeness of electronic labels submitted to FDA and will also identify any factors that result in inaccurate or missing information.  
  • Billing for Immunosuppressive Drugs: The OIG will review Medicare Part B immunosuppressive drug claims to determine whether they were billed according to their FDA-approved labels and whether Medicare paid for immunosuppressive drugs that should not have been used in combination with other immunosuppressive drugs.  
  • Payments for Off-Label Anticancer Pharmaceuticals and Biologics: The OIG will determine whether patients with particular indications were prescribed anti-cancer drugs approved by FDA for such indications before resorting to anti-cancer drugs not approved for those indications and, if so, whether there were improvements in the patients' medical conditions before the use of off-label drugs. If the beneficiaries' medical conditions improved before the use of off-label drugs, the OIG will determine how much Medicare could have saved had anti-cancer drugs continued to be used within indicated usage.  
  • Medicaid Payments for Drugs Not Approved for Use by Children: The OIG will review Medicaid-paid claims to determine whether payments were for drugs not approved by the FDA for use by children.  

The OIG has also identified the following areas for continued review in FY 2011 as Work in Progress Programs:

  • Oversight of State Food Facility Inspections: OIG will continue to review FDA's oversight of food facility inspections conducted by states under contract with FDA and determine the extent to which FDA is meeting its program guidelines, and the extent to which deficiencies are identified and corrected.  
  • 510(k) Process for Device Approval: OIG will continue to review FDA's internal controls and quality review procedures for the 510(k) device approval process and examine the extent to which manufacturers submit data on long-term safety under the 510(k) process and FDA's post-marketing surveillance of such medical devices.  
  • FDA's Policies and Procedures for Resolving Scientific Disputes: OIG will also continue to review the FDA Center for Devices and Radiological Health's (CDRH) policies and procedures for resolving scientific disputes about approval of device and assess the extent to which regulations, policies and procedures were followed during the dispute resolution process.  

For more information on the FY 2011 OIG Work Plan, please see the more comprehensive Alston & Bird client advisory available online.